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METHADONE HYDROCHLORIDE DTF 1MG/1ML ORAL SOLUTION

Active substance(s): METHADONE HYDROCHLORIDE

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52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

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● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

52mm x 98mm

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution

500ml

Page 4

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
DUMMY
L1566
PHARMACODE

52mm x 98mm

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

DUMMY
PHARMACODE

If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

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52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

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52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
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13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

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52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

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● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

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The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.






What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It comes in a brown glass bottle holding 100ml or 500ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

DUMMY
PHARMACODE
0

10

20

30

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Keep out of the sight and reach of children.

ce
nt
ral
ner
vous
system

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

L1566

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Glass)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125591

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1566

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1519

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

1 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

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52mm x 98mm

Page 1

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52mm x 100mm

52mm x 98mm

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52mm x 96mm

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52mm x 97mm

methadone dtf
#1 mg/#1 ml
oral solution
Base Page

52mm x 144mm

0

10

20

30

BRAILLE TRANSLATION

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Glass)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125591

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1566

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1519

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

2 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

ner
vous
system

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
DUMMY
L1566
PHARMACODE

methadone dtf
#1 mg/#1 ml
oral solution
ce
nt
ral

● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

52mm x 98mm

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution

500ml

Page 4

52mm x 98mm

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

DUMMY
PHARMACODE

If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.






What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It comes in a brown glass bottle holding 100ml or 500ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

DUMMY
PHARMACODE
0

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

20

30

BRAILLE TRANSLATION

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Keep out of the sight and reach of children.

ce
nt
ral
ner
vous
system

10

L1566

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Glass)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125591

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1566

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1519

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

3 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
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Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

ce
nt
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system

52mm x 98mm
● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm
500ml

Page 4

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
E8T77RBF1

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

52mm x 98mm
If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine., SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

0

10

20

30

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.

ce
nt
ral
ner
vous
system

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

E8T77RBF1

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

539

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125393

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

E8T77RBF1

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1516

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

1 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

03/04/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

2

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Page 1

Page 10

52mm x 100mm

52mm x 98mm

Page 4

52mm x 98mm

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52mm x 98mm

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Page 6

52mm x 96mm

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52mm x 96mm

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52mm x 96mm

Page 8

52mm x 98mm

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52mm x 96mm

Page 9

52mm x 100mm

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Page 16

52mm x 98mm

52mm x 97mm

methadone dtf
#1 mg/#1 ml
oral solution
Base Page

52mm x 144mm

0

10

20

30

BRAILLE TRANSLATION

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

539

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125393

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

E8T77RBF1

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1516

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

2 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

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Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

ner
vous
system

● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
E8T77RBF1

methadone dtf
#1 mg/#1 ml
oral solution
ce
nt
ral

52mm x 98mm

Page 10

52mm x 100mm
500ml

Page 4

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

52mm x 98mm
If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

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52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine., SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

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52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

0

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

20

30

BRAILLE TRANSLATION

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
ce
nt
ral
ner
vous
system

10

E8T77RBF1

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

539

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125393

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

E8T77RBF1

Tabbed:

N/A

Pack Size:

500ml

Previous Item Code:

L1516

MAIN BODY TEXT

500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

3 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

03/04/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

2

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

ce
nt
ral

ner
vous
system

52mm x 98mm
● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm
2500ml

Page 4

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
E8TH2RBF1

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time)
to make up for a forgotten dose.

52mm x 98mm
If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
2500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

0

10

20

30

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.

ce
nt
ral
ner
vous
system

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

E8TH2RBF1

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

TBC

Pharmacode:

540

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution

Dimensions:

52 x 781mm

EAN Code:

5 016119 125997

APPROVALS

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Folded Size:

52 x 144mm

Strength:

1mg/1ml

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E8TH2RBF1

Tabbed:

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2500ml

Previous Item Code:

L1517

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52mm x 97mm

52mm x 98mm

Page 1

Page 10

52mm x 100mm

52mm x 98mm

Page 4

52mm x 98mm

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52mm x 98mm

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Page 6

52mm x 96mm

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52mm x 98mm

52mm x 97mm

methadone dtf
#1 mg/#1 ml
oral solution
Base Page

52mm x 144mm

0

10

20

30

BRAILLE TRANSLATION

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

TBC

Pharmacode:

540

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution

Dimensions:

52 x 781mm

EAN Code:

5 016119 125997

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

E8TH2RBF1

Tabbed:

N/A

Pack Size:

2500ml

Previous Item Code:

L1517

MAIN BODY TEXT

2500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

2 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

28/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

ner
vous
system

● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
E8TH2RBF1

methadone dtf
#1 mg/#1 ml
oral solution
ce
nt
ral

52mm x 98mm

Page 10

52mm x 100mm
2500ml

Page 4

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time)
to make up for a forgotten dose.

52mm x 98mm
If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution

6. Contents of the pack and other information

Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
2500ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

0

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

20

30

BRAILLE TRANSLATION

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
ce
nt
ral
ner
vous
system

10

E8TH2RBF1

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

TBC

Pharmacode:

540

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution

Dimensions:

52 x 781mm

EAN Code:

5 016119 125997

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

E8TH2RBF1

Tabbed:

N/A

Pack Size:

2500ml

Previous Item Code:

L1517

MAIN BODY TEXT

2500ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

3 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

28/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

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● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

52mm x 98mm

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution

5000ml

Page 4

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
DUMMY
L1565
PHARMACODE

52mm x 98mm

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

DUMMY
PHARMACODE

If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

Page 15

52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







6. Contents of the pack and other information
What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
5000ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

DUMMY
PHARMACODE
0

10

20

30

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.

ce
nt
ral
ner
vous
system

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

L1565

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125690

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1565

Tabbed:

N/A

Pack Size:

5000ml

Previous Item Code:

L1518

MAIN BODY TEXT

5000ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

1 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Page 1

Page 10

52mm x 100mm

52mm x 98mm

Page 4

52mm x 98mm

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52mm x 98mm

Page 5

Page 6

52mm x 96mm

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52mm x 96mm

Page 12

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Page 13

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Page 8

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52mm x 96mm

Page 9

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Page 15

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Page 16

52mm x 98mm

52mm x 97mm

methadone dtf
#1 mg/#1 ml
oral solution
Base Page

52mm x 144mm

0

10

20

30

BRAILLE TRANSLATION

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125690

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1565

Tabbed:

N/A

Pack Size:

5000ml

Previous Item Code:

L1518

MAIN BODY TEXT

5000ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

2 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

Page 2

Page 3

52mm x 97mm

52mm x 98mm

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as
Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of
medicines called Narcotic Analgesics.
Methadone is used:
● to treat opioid drug addiction
● to treat moderate to severe pain
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
● you are allergic to methadone or any other ingredients of this medicine (listed in section 6).
An allergic reaction can include a rash, itching or shortness of breath
● you have severe breathing problems or a history of asthma. You must not use this medicine
during an asthma attack. If you give this medicine to yourself (self-administration), wait until the
asthma attack has passed and you are fully recovered
● you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have
taken a MAOI medicine in the past two weeks (see ‘Other medicines and Methadone Solution’)
● you are dependent on any other drugs
● you are in labour

Page 1

ner
vous
system

Page 11

52mm x 98mm

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.
Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086
DUMMY
L1565
PHARMACODE

methadone dtf
#1 mg/#1 ml
oral solution
ce
nt
ral

● you have phaeochromocytoma, a tumour of the adrenal glands
● you have a bowel disorder known as paralytic ileus
● you have or have recently had a head injury
● children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
before taking methadone.
Warnings and precautions
Talk to your doctor before taking Methadone Solution if:
● you have liver or kidney problems
● you have problems with your gallbladder and bile duct
● you have epilepsy
● you are addicted to alcohol
● you have low thyroid function (hypothyroid)
● you have problems with your adrenal glands. These are linked to your kidneys
● you have an enlarged prostate gland
● you have low blood pressure
● you are in shock
● you have a muscle weakness disease called myasthenia gravis
● you have bowel problems

Page 10

52mm x 100mm

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

52mm x 98mm

1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

Methadone Hydrochloride DTF 1mg/1ml Oral Solution

5000ml

Page 4

52mm x 98mm

Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
● if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital
straight away. Take the medicine pack with you
● the signs you may notice are difficulty in breathing;
feeling very drowsy which may lead to a stupor or coma;
very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness.
In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart
attack which could lead to death.
If you forget to take Methadone Solution
● if you forget a dose do not take it. Wait until the next dose is due and take only that amount
● do not take a double dose (two doses at the same time) to make up for a forgotten dose.

DUMMY
PHARMACODE

If you stop taking Methadone Solution
● do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal
effects
● your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to
Methadone Solution.
An allergic reaction may include:
● swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
● severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
● heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
● if your breathing becomes slow and shallow
● worsening of the pressure inside your head if you already have this condition following an
11
injury to your brain or brain disease.

Page 5

Page 6

52mm x 96mm

52mm x 96mm

● you have a history of irregular heart beat
● you have a history of heart disease
● you have a family history of people dying suddenly without cause
● you have low potassium, sodium or magnesium levels
● you are pregnant or breast-feeding
● you are extremely ill or an older person. You may be more sensitive to the medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines bought without a prescription, including herbal medicines. This is because
methadone can affect the way some other medicines work. Also some medicines can affect the
way methadone works.
You must not take Methadone Solution:
● at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).
Some medicines can increase the risk of heart problems when used with methadone.
Talk to your doctor before taking methadone if you are taking:
● medicines for heart problems such as verapamil and enalapril
● medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:
● medicines that dull your senses such as:
- medicines for depression (for example, SSRIs such as fluvoxamine and fluoxetine, SNRIs
such as venlafaxine, TCAs such as amitriptyline)
- medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● serotonergic medicines used to treat migraine, such as sumatriptan
● cimetidine, used to treat stomach ulcers
● rifampicin, used to treat tuberculosis (TB)
● medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone
● medicines that make your urine acidic such as ascorbic acid (vitamin C)
● narcotic painkillers such as codeine and pentazocine
● naloxone used to reverse the effects of opioid drugs
● medicines used to stop opioid drugs working such as naltrexone and buprenorphine
● medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor
may have to change the amount of methadone you take whilst on these medicines
● antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
● medicines used to treat fungal infections such as ketoconazole or fluconazole

Page 12

Page 7

52mm x 98mm

Keep taking the medicine but tell your doctor straight away if you get any of the following side
effects:
● if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
● feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
● feeling weak, tired
● weight gain
● water retention
● constipation
● rash, that may appear and disappear
● sweating a lot more than usual
● blurred vision, small pupils, dry eyes
● feeling of dizziness
● changes in your mood, feeling “high” or over excited, feeling drowsy
● seeing or hearing things that are not there (hallucinations).
12

13

● colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions.
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Taking this medicine
● this medicine contains 1mg of methadone in each 1ml
● take this medicine by mouth.
Adults
For addiction
● the starting dose is 10mg to 20mg (10ml to 20ml) each day
● the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
● the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
● the dose may be changed by your doctor.
Older people and very ill people
● if you have to have repeated doses of this medicine, the doctor may want to monitor you
more closely.

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52mm x 98mm

Uncommon (affects less than 1 in 100 people)
● feeling dizzy, particularly when standing up. This may be a sign that you have low blood
pressure
● headache
● feeling down (dysphoria), agitation, confusion, difficulty sleeping
● itching, rashes
● dry mouth or nose, inflammation of the tongue, facial flushing
● breast growth and production of breast milk
● difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle
spasms
● low body heat (hypothermia)
● lower sexual urge or desire
● painful periods or lack of periods.

52mm x 100mm

Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you
sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
● Do not drive while taking this medicine until you know how it affects you.
● It is an offence to drive if this medicine affects your ability to drive.
● However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Methadone Solution contains methyl and proypyl parahydroxybenzoates, sucrose, liquid maltitol,
tartrazine and sunset yellow:
● methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
● sucrose (0.9g per 5ml) and liquid maltitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sucrose should be taken into account in patients with diabetes mellitus.
Sucrose may be harmful to your teeth

Page 14

52mm x 96mm

Page 9

52mm x 98mm

● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as
ondansetron, used to treat nausea and vomiting
● medicines used to treat Parkinson’s disease and atropine
● mexiletine used to treat unusual heart rhythms.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can
make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadone Solution if you are pregnant or likely to become
pregnant
● take care if you are taking a pregnancy test as the methadone may interfere with the results
● you should not take this medicine whilst you are in labour
● do not breast-feed if you are taking Methadone Solution. Talk to your doctor or midwife if you
are thinking of breast-feeding while you are taking methadone as it may affect your baby.

Page 13

52mm x 96mm

Page 8

Page 16

52mm x 98mm

The following side effects have also been reported
● loss of appetite
● swollen arms and legs. This may be a sign of your body holding onto more water than usual
● reduction in blood platelets, which increase the risk of bleeding or bruising
● low potassium and magnesium which will be found by blood tests
● eye disorders in newborn babies
● reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the
methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone
solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
14

52mm x 97mm

5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator. Protect from light
Do not use after the expiry date (month, year) stated on the label and carton
Use within 1 month of opening
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your
pharmacist
● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.







6. Contents of the pack and other information
What Methadone Solution contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110),
green s (E142), poloxamer 188, simethicone emulsion 30% and purified water.
What Methadone Solution looks like and contents of the pack
● A green solution.
It is available in plastic bottles of 500ml, 2500ml and 5000ml. Other pack sizes are available.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds,
LS11 9XE, UK.
This leaflet was last revised in 03/2017.

15

16

Base Page

52mm x 144mm
5000ml

Methadone
Hydrochloride
DTF 1mg/1ml
Oral Solution

CD
Each 1ml contains 1mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216), propylene glycol (E1520), liquid maltitol (E965),
sucrose, E102 and E110.
See leaflet for further information.

DUMMY
PHARMACODE
0

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0086

20

30

BRAILLE TRANSLATION

Administration: For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while
taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.

methadone dtf methadone dtf
#1 mg/#1 ml #1 mg/#1 ml
oral solution oral solution

Storage: Do not store above 25°C, do not store in refrigerator.
Protect from light. Use within 1 month of opening.
Keep out of the sight and reach of children.
ce
nt
ral
ner
vous
system

10

L1565

40

50

80

90

100

JOB SPECIFICATION

Product Name:

Keyline Ref:

UKLB136

Pharmacode:

TBC

Methadone Hydrochloride DTF 1mg/1ml
Oral Solution (Plastic)

Dimensions:

52 x 781mm

EAN Code:

5 016119 125690

APPROVALS

No. of Colours: 3 + Varnish

Folded Size:

52 x 144mm

Strength:

1mg/1ml

New Item Code:

L1565

Tabbed:

N/A

Pack Size:

5000ml

Previous Item Code:

L1518

MAIN BODY TEXT

5000ml

Supplier Code:

N/A

Font Type:

Font Size:

Page Number:

3 of 3

Univers Condensed
Univers Bold Condensed

6.25pt

PREFLIGHT
VERSION:

Bottle Size:

Date:

Date:

COLOURS

29/03/17

-

Operator:

Operator:

DH

-

-

70

JOB INFORMATION

ARTWORK
VERSION:

1

60

Design Icon: CNS

Print
Colours:

Third Party Approval Required

TICK APPLICABLE BOX

PANTONE
7474

PANTONE
405

BLACK

877

485

Non-print
Colours:

Signature:

KEYLINE

Authority Approval Supplied

BRAILLE

SUBSTRATE

YES

N/A

Date:
TICK APPLICABLE BOX

Regulatory Sign-off

BRAILLE

NO

Name:

Name:
BLACK

YES

Signature:

Date:

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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