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METHADOSE 20MG/1ML ORAL CONCENTRATE

Active substance(s): METHADONE HYDROCHLORIDE

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PAGE 2 - 52mm x 97mm

Methadose® 20mg/1ml Oral Concentrate Methadone Hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
● 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 only for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
● 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.
In this leaflet
1. What Methadose is and what it is used for
2. Before you take Methadose
3. How to take Methadose
4. Possible side effects
5. How to store Methadose
6. Further information

PAGE 3 - 52mm x 98mm

PAGE 4 - 52mm x 96mm

PAGE 5 - 52mm x 96mm

1. What Methadose is and what it is used for
The name of your medicine is Methadose 20mg/1ml. It contains methadone hydrochloride. This
belongs to a group of medicines called Narcotic Analgesics.
Methadose is used to treat opioid drug addiction.
2. Before you take Methadose
Do not take Methadose and tell your doctor if:
● you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6
below). 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 ‘Taking other medicines’)
● you are dependent on any other drugs
● you are in labour
● 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 Methadose.
Take special care with Methadose
Before you take this medicine, tell your doctor 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
● 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
Methadose.
Taking other medicines
Please 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
Methadose can affect the way some other medicines work. Also some medicines can affect the way
Methadose works.
You must not take Methadose:
● 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 Methadose. Talk to your
doctor before taking Methadose 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, fluvoxamine,
fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● cimetidine, used to treat stomach ulcers

PAGE 9 - 52mm x 98mm

PAGE 10 - 52mm x 98mm

PAGE 11 - 52mm x 96mm

PAGE 1 - 52mm x 100mm

Methadose®
20mg/1ml
Oral Concentrate
Methadone Hydrochloride

CD
Each 1ml contains 20mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216) and propylene glycol (E1520).
See leaflet for further information.
Administration: For oral use. This product is intended for
use with a diluent. 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: Discard 3 months after opening.
Once diluted it has a 3 months shelf life.
Do not store above 25°C, do not store in a refrigerator.
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 0427/0100 L1522

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.
Children
Children must not take this medicine.
If you take more Methadose 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.
If you forget to take Methadose
● 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.
If you stop taking Methadose
● 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.

BASE PAGE - 52mm x 144mm

Methadose®
20mg/1ml
Oral Concentrate
Methadone Hydrochloride

CD
Each 1ml contains 20mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216) and propylene glycol (E1520).
See leaflet for further information.
Administration: For oral use. This product is intended for
use with a diluent. 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: Discard 3 months after opening.
Once diluted it has a 3 months shelf life.
Do not store above 25°C, do not store in a refrigerator.
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 0427/0100

L1522

4. Possible side effects
Like all medicines, Methadose 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
Methadose.
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 injury to
your brain or brain disease.
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).
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

PAGE 6 - 52mm x 98mm
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
● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide 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 Methadose.
Taking Methadose with food and drink
Do not drink alcohol whilst taking Methadose. This is because Methadose can make you feel sleepy
and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.








PAGE 7 - 52mm x 98mm
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadose 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 Methadose. Talk to your doctor or midwife if you are thinking of
breast-feeding while you are taking methadone as it may affect your baby.
Driving and using machines
Methadose 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.

PAGE 12 - 52mm x 96mm
● 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.
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.
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 Methadose.
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.

PAGE 13 - 52mm x 98mm
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.








5. How to store Methadose
Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator
Take back to the pharmacy 3 months after you first open it or 3 months after it has been diluted
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 Methadose if you notice anything wrong with the medicine. Talk to your pharmacist
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

PAGE 8 - 52mm x 100mm
Important information about what is in Methadose:
This medicine contains:
● methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may
happen some time after starting the medicine.
3. How to take Methadose
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or
pharmacist if you are not sure.
Taking this medicine
● this medicine contains 20mg of methadone in each 1ml
● take this medicine by mouth
● this medicine is intended for use with another liquid to dilute it with (diluent). Your pharmacist or
prescriber should dilute the concentrate to provide the appropriate concentration of drug in a
5ml dose.
Adults
● the starting dose is 10mg to 20mg (0.5ml to 1ml) each day
● the doctor can increase this to 40mg to 60mg (2ml to 3ml) each day.

PAGE 14 - 52mm x 97mm
6. Further information
What Methadose 20mg/1ml Oral Concentrate contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), caramel (E150) and purified water.
What Methadose 20mg/1ml Oral Concentrate looks like and contents of the pack
● Before dilution: a pale brown liquid
● After dilution: the colour will range from green to blue depending upon the concentration
It comes in a brown glass bottle holding 150ml 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 02/2016.

PAGE 2 - 52mm x 97mm

PAGE 3 - 52mm x 98mm

PAGE 4 - 52mm x 96mm

PAGE 5 - 52mm x 96mm

PAGE 6 - 52mm x 98mm

PAGE 7 - 52mm x 98mm

PAGE 8 - 52mm x 100mm

PAGE 1 - 52mm x 100mm

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PAGE 10 - 52mm x 98mm

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PAGE 12 - 52mm x 96mm

PAGE 13 - 52mm x 98mm

PAGE 14 - 52mm x 97mm

methadose
#20 mg/#1 ml
oral
concentrate
BASE PAGE - 52mm x 144mm

Braille reads:

methadose
#20 mg/#1 ml
oral
concentrate

PAGE 2 - 52mm x 97mm

Methadose® 20mg/1ml Oral Concentrate Methadone Hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
● 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 only for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
● 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.
In this leaflet
1. What Methadose is and what it is used for
2. Before you take Methadose
3. How to take Methadose
4. Possible side effects
5. How to store Methadose
6. Further information

PAGE 3 - 52mm x 98mm

PAGE 4 - 52mm x 96mm

PAGE 5 - 52mm x 96mm

1. What Methadose is and what it is used for
The name of your medicine is Methadose 20mg/1ml. It contains methadone hydrochloride. This
belongs to a group of medicines called Narcotic Analgesics.
Methadose is used to treat opioid drug addiction.
2. Before you take Methadose
Do not take Methadose and tell your doctor if:
● you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6
below). 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 ‘Taking other medicines’)
● you are dependent on any other drugs
● you are in labour
● 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 Methadose.
Take special care with Methadose
Before you take this medicine, tell your doctor 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
● 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
Methadose.
Taking other medicines
Please 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
Methadose can affect the way some other medicines work. Also some medicines can affect the way
Methadose works.
You must not take Methadose:
● 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 Methadose. Talk to your
doctor before taking Methadose 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, fluvoxamine,
fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down
called tranquillisers
● cimetidine, used to treat stomach ulcers

PAGE 9 - 52mm x 98mm

PAGE 10 - 52mm x 98mm

PAGE 11 - 52mm x 96mm

PAGE 1 - 52mm x 100mm

Methadose®
20mg/1ml
Oral Concentrate
Methadone Hydrochloride

CD
Each 1ml contains 20mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216) and propylene glycol (E1520).
See leaflet for further information.

methadose
#20 mg/#1 ml
oral
concentrate

Administration: For oral use. This product is intended for
use with a diluent. 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: Discard 3 months after opening.
Once diluted it has a 3 months shelf life.
Do not store above 25°C, do not store in a refrigerator.
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 0427/0100 L1522

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.
Children
Children must not take this medicine.
If you take more Methadose 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.
If you forget to take Methadose
● 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.
If you stop taking Methadose
● 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.

BASE PAGE - 52mm x 144mm

Methadose®
20mg/1ml
Oral Concentrate
Methadone Hydrochloride

CD
Each 1ml contains 20mg Methadone Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates
(E218 and E216) and propylene glycol (E1520).
See leaflet for further information.
Administration: For oral use. This product is intended for
use with a diluent. 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: Discard 3 months after opening.
Once diluted it has a 3 months shelf life.
Do not store above 25°C, do not store in a refrigerator.
Keep out of the sight and reach of children.

ce
nt
ral

ner
vous
system

Braille reads:

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK.
PL 0427/0100

methadose
#20 mg/#1 ml
oral
concentrate

L1522

4. Possible side effects
Like all medicines, Methadose 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
Methadose.
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 injury to
your brain or brain disease.
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).
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

PAGE 6 - 52mm x 98mm
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
● St. John’s Wort - a herbal preparation for depression
● cyclizine, domperidone and metoclopramide 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 Methadose.
Taking Methadose with food and drink
Do not drink alcohol whilst taking Methadose. This is because Methadose can make you feel sleepy
and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.








PAGE 7 - 52mm x 98mm
Pregnancy and Breast-feeding
● talk to your doctor before taking Methadose 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 Methadose. Talk to your doctor or midwife if you are thinking of
breast-feeding while you are taking methadone as it may affect your baby.
Driving and using machines
Methadose 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.

PAGE 12 - 52mm x 96mm
● 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.
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.
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 Methadose.
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.

PAGE 13 - 52mm x 98mm
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.








5. How to store Methadose
Keep out of the sight and reach of children
Store below 25°C but not in a refrigerator
Take back to the pharmacy 3 months after you first open it or 3 months after it has been diluted
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 Methadose if you notice anything wrong with the medicine. Talk to your pharmacist
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

PAGE 8 - 52mm x 100mm
Important information about what is in Methadose:
This medicine contains:
● methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may
happen some time after starting the medicine.
3. How to take Methadose
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or
pharmacist if you are not sure.
Taking this medicine
● this medicine contains 20mg of methadone in each 1ml
● take this medicine by mouth
● this medicine is intended for use with another liquid to dilute it with (diluent). Your pharmacist or
prescriber should dilute the concentrate to provide the appropriate concentration of drug in a
5ml dose.
Adults
● the starting dose is 10mg to 20mg (0.5ml to 1ml) each day
● the doctor can increase this to 40mg to 60mg (2ml to 3ml) each day.

PAGE 14 - 52mm x 97mm
6. Further information
What Methadose 20mg/1ml Oral Concentrate contains
● The active ingredient is methadone hydrochloride
● The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
propylene glycol (E1520), caramel (E150) and purified water.
What Methadose 20mg/1ml Oral Concentrate looks like and contents of the pack
● Before dilution: a pale brown liquid
● After dilution: the colour will range from green to blue depending upon the concentration
It comes in a brown glass bottle holding 150ml 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 02/2016.

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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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