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METHADONE 1 MG/ML ORAL SOLUTION SUGAR FREE

Active substance(s): METHADONE HYDROCHLORIDE

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ARTWORK INFORMATION:
PRODUCT:

Methadone 1mg/ml Oral Solution Sugar Free

LICENCE:

PL 17507/0032

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 210 mm (h) x 297 mm (w) [flat]
A1000082/3

VERSION:

1; 13/05/2015

INK:

Black

A1000082/3
0000/0/AM

ID CODE:

APPROVED BY
HEALTH AUTHORITY:

Patient Information Leaflet

Methadone 1mg/ml
Oral Solution Sugar Free
Methadone Hydrochloride

Read all of this leaflet carefully before you start taking Methadone 1mg/ml Oral Solution Sugar Free (now called Methadone Oral
Solution throughout the leaflet). It contains important information on how to take it.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or your pharmacist.
● This medicine has been prescribed 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 get serious, or if you have any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet






1. What is Methadone Oral Solution and what is it for
2. Before taking Methadone Oral Solution
3. How to take Methadone Oral Solution
4. Possible side effects
5. Storing Methadone Oral Solution
6. Further information
● you are dependent on any other drugs
1. What is Methadone Oral
● you are in labour
Solution and what is it for
● children must not be given this medicine.
The name of your medicine is Methadone
● you have liver or kidney problems
1mg/1ml Oral Solution Sugar Free (now called
● you have a bowel problem called ulcerative
Methadone Oral Solution throughout the
colitis.
leaflet). It contains methadone hydrochloride
● you are addicted to alcohol
as an active ingredient. This belongs to a group
● you have recently had a head injury.
of medicines called Narcotic Analgesics.
Do not take this medicine if any of the above
points apply to you. If you are not sure, talk to
Methadone is used to treat opioid drug
your doctor before taking methadone.
addiction.

2. Before taking Methadone Oral
Solution
X Do not use this medicine 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 (selfadministration), 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’)

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! Take special care with Methadone
Oral Solution:

Before you take this medicine, tell your doctor if:
● you have epilepsy
● 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 methadone.

! 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 methadone can
affect the way some other medicines work.
Also some medicines can affect the way
methadone works.
You must not take Methadone Oral 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
medicine 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
● 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 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.
If any of the above apply to you, talk to your
doctor before taking Methadone Solution.

! Taking Methadone Oral Solution with
food and drink

● Do not drink alcohol whilst taking
Methadone Oral Solution. This is because
Methadone Oral Solution can make you feel
sleepy and drinking alcohol will make you
even more sleepy.

! Pregnancy and Breast-feeding

● talk to your doctor before taking Methadone
Oral 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 Oral Solution.

! Driving and using machines

● Methadone Oral Solution will severely affect
your ability to drive or use machines, whilst
taking it and afterwards. You should only
start doing these activities again with the
permission of your doctor.
The medicine can affect your ability to drive as
it may make you sleepy or dizzy.
● 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
continued, please turn over...

13/05/2015 11:24



● 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.

i

Important information about what is
in Methadone Oral Solution:

This product also contains Tartrazine (E102)
and Sunset Yellow (E110), which may cause
allergic reactions.

3. How to take Methadone Oral
Solution
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
• t his medicine contains 1mg of methadone in
each 1ml
• t ake this medicine by mouth.
Adults
• t he starting dose is 10mg to 20mg (10ml to
20ml) each day
• t he doctor can increase this to 40mg to
60mg (40ml to 60ml) each day.
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 Methadone Oral
Solution than you should

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! If you forget to take Methadone Oral
Solution

• if you forget a dose do not take it. Wait until
the next dose is due and take only that
amount
•d
 o not take a double dose (two doses at the
same time) to make up for a forgotten dose.

! If you stop taking Methadone Oral
Solution:

• do not stop taking this medicine unless your
doctor tells you to as you may suffer
withdrawal effects
• y our doctor will tell you how to lower the
dose gradually.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Methadone Oral Solution
can cause side effects although not everyone
gets them.
Stop taking this medicine and see a doctor
straight away if you have an allergic reaction
to Methadone Oral Solution.
An allergic reaction may include:
• s welling of your face, lips, tongue or throat or
difficulty breathing or swallowing
• s evere itching of your skin with raised lumps.
Stop taking this medicine and see a doctor
straight away if you have any of the following:
•h
 eart 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 become slow and shallow.

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
•w
 orsening of the pressure inside your head if
you already have this condition following an
injury to your brain or brain disease.
Tell your doctor if you get any of these side
effects:
• feeling sick (nausea) or being sick (vomiting)
• c onstipation
• s weating a lot more than usual
• feeling dizzy, particularly when standing up.
This may be a sign that you have low blood
pressure
• s mall pupils
•b
 reast growth and production of breast milk
•d
 ifficulty in passing water (urine), pain in the
lower back and abdomen caused by muscle
spasms
•d
 ry mouth, eyes or nose, facial flushing
• feeling drowsy, confused or restless
• c hanges in your mood, feeling “high” or over
excited
• s eeing or hearing things that are not there
(hallucinations)
•h
 eadache, rashes
• low body heat (hypothermia)
• lower sexual urge or desire
•p
 ainful periods or lack of periods.
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 Oral Solution.
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 (Website: www.mhra.gov.uk/
yellowcard).By reporting side effects you can
help provide more information on the safety of
this medicine.

5. Storing Methadone Oral
Solution
•K
 eep out of the reach and sight of children.
•D
 o not store above 25ºC. Store in the
original container. Discard after 4 weeks of
first opening.
•D
 o not use Methadone Oral Solution after
the expiry date which is stated on the bottle
after Exp:. The expiry date refers to the last
day of that month.
•M
 edicines should not be disposed via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
Methadone 1 mg/ml Oral Solution Sugar Free
is a clear green solution.
Each 1 ml of oral solution contains 1 mg of
methadone hydrochloride. It also contains:
Tartrazine (E102), Sunset yellow (E110),
Green S (E142), sodium saccharin,
hydrochloric acid, sodium benzoate (E211),
glycerol and purified water.
Each bottle contains 500ml of oral solution.
A double ended 5ml and 2.5ml polypropylene
spoon is also included to help measure the
dose.
Marketing Authorisation holder:
Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street, Ruislip,
Middlesex, HA4 7TL
PL 17507/0032
Manufacturer:
Percuro Medica Ltd.
Unit 5 Powergate Business Park, Volt Avenue,
Park Royal, London NW10 6PW

For information in large print,
tape, CD or Braille, telephone
01895 627 420
This leaflet was updated in May 2015.
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If you accidentally take an overdose of your
medicine, either call your doctor straight away,
or go to your nearest hospital casualty
department. Do not drive yourself there as you
may begin to feel sleepy. Always take any
remaining medicine, the container and the
label with you, so that the medicine can be
identified.

You may experience the following symptoms if
you take too much of this medicine:
•D
 ifficulty in breathing
•E
 xtreme drowsiness, being unaware (stupor)
or loss of consciousness (coma)
•V
 ery small pupils
•C
 old and clammy skin
•A
 very slow pulse rate
•M
 uscle weakness.
In extreme cases, heart and blood pressure
can be affected, leading to heart attack and
death.

13/05/2015 11:24

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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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