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METHADONE 1MG-ML ORAL SOLUTION SUGAR-FREE

Active substance(s): METHADONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER D02775

Methadone 1mg in 1ml Oral Solution sugar-free
Methadone Hydrochloride

(This medicine will be referred to as Methadone oral solution in this leaflet)
If any of the conditions above apply to you, please consult your
Read all this leaflet carefully before you take Methadone
doctor.
oral solution

In this leaflet:
1. What Methadone oral solution is and what it is used for
2. Before you take Methadone oral solution
3. How to take Methadone oral solution
4. Possible side effects
5. Storing Methadone oral solution
6. Further information
This leaflet contains a summary of the information available for
this medicine. You should ask your doctor or pharmacist if you are
unsure about any aspect of this medicine.

1. What Methadone oral solution is and what it is
used for
Methadone is a synthetic opiate (a morphine-like drug) used
in the treatment of addiction in order to reduce withdrawal
symptoms.

2. Before you take Methadone oral solution
Do not take Methadone oral solution if:
• you are allergic (hypersensitive) to methadone or any of the
ingredients of this medicine (listed in section 6)
• you have a head injury and the pressure inside your brain is
higher than it should be (check this with your doctor). You
might be getting bad headaches
• you are suffering from alcoholism
• you are in labour
• you are taking, or have recently stopped taking, a type of
medicine called Monoamine Oxidase Inhibitors (MAOIs) which
are used to treat depression
• you are at risk of developing an obstruction of the intestine
• you have any problems with your breathing or any chronic lung
disease
• you are having an asthma attack. Do not take your dose until
you have completely recovered.
• you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
medicinal product
Methadone oral solution is not suitable for children.
Take special care with Methadone oral solution
Tell your doctor if:
• you have history of asthma or breathing difficulties
• you have bowel problems
• you have liver or kidney problems
• you have a history of convulsions, fits or epilepsy
• you have a history of low blood pressure
• you have a history of under-active thyroid gland, or problems
with your adrenal glands
• you have a history of enlarged prostate gland
• you have condition that causes severe muscle weakness and
fatigue (myasthenia gravis)
• you are in shock.

Methadone may affect the electrical signals which control your
heart contractions, particularly at high doses.
Tell your doctor if:
• you have a history of heart problems
• you have liver disease
• you have any blood abnormalities such as low levels of
potassium or magnesium
• you have a history of sudden death in the family.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Tell your doctor if you are taking any of the following:
• medicines used to treat addiction e.g. naltrexone and
buprenorphine
• cimetidine (a medicine used to treat stomach ulcers)
• drugs used to treat epilepsy (e.g. phenytoin and
carbamazepine)
• naloxone (a medicine used to treat an overdose of opioid
medicines)
• antibiotics (medicines used to treat bacterial infections)
• antifungals (medicines used to treat fungal infections)
• medicines that make urine more acidic e.g. ammonium
chloride
• antiviral drugs including some medicines used to treat HIV
e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and
abacavir
• metoclopramide or domperidone (medicines used to stop you
feeling and being sick)
• mexiletine (a drug used to treat heart irregularities)
• medicines used to treat depression including fluvoxamine,
tricyclic antidepressants such as amitriptyline and imipramine,
or MAOIs including moclobemide
• CNS depressants (medicines that act on the brain and cause
drowsiness or sleepiness)
• other opioid type drugs e.g. morphine
• pentazocine (a pain killer)
• medicines used to help you relax (tranquillisers)
• medicines used to help you to sleep (sedatives).

Other medicines you may be taking can also affect the heart.
You must tell your doctor about any other medicines that you
are taking as they may be dangerous if they are taken with
methadone. In these situations your doctor may decide that it is
necessary to monitor your heart with an electrocardiogram (ECG)
at the start of treatment to ensure that these effects do not occur.
Taking Methadone oral solution with food and drink
You must not drink alcohol whilst you are taking Methadone oral
solution as this could cause serious side effects.
Pregnancy, breast-feeding and labour
Methadone oral solution should not be taken during labour. If
you are pregnant or breast-feeding you should discuss this with
your doctor before taking Methadone oral solution.
Continued overleaf

If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

3. How to take Methadone oral solution
You must only take Methadone oral solution by mouth. Under
no circumstances should you inject this product as injection may
cause serious and permanent damage to your body with possibly
fatal consequences.
Your doctor will tell you how much Methadone oral solution you
need to take, and how often you need to take it. It is important
that you do not take more than the dose agreed with your doctor.
You can become dependant on Methadone oral solution.
Adults:
The usual initial dose is 10-20mg a day. The dose will be slowly
increased until you show no signs of withdrawal or intoxication.
Elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated
doses with caution.
Children:
Not recommended. There is a serious risk of poisoning. Remember
to keep your medicine safely where children can not get it.
If you forget to take Methadone oral solution
During a course of treatment it is important that, should you miss
a dose, you take the dose as soon as you remember. However, if it
is almost time for you to take your next dose, miss the dose and
wait until the next scheduled dose.
DO NOT TAKE A DOUBLE DOSE.
If you take more Methadone oral solution than you should
If you take too much Methadone oral solution, you can experience
the following:
• difficulty in breathing
• extreme sleepiness, fainting or coma
• pin point pupils
• muscle weakness
• cold and clammy skin
• slow heartbeat, low blood pressure, heart attack or shock. in
severe cases death may occur.

4. Possible side effects
Like all medicines, Methadone oral solution can cause side effects,
though not everybody gets them.
Side effects which may occur include:
• dizziness (including vertigo), drowsiness, hallucinations
• nausea (feeling sick) or vomiting (being sick), constipation, a dry
mouth
• headaches, raised pressure in the brain
• rashes or itching
• sweating
• reduced blood pressure (you may feel dizzy on standing up)
• pin point pupils
• confusion, mood changes
• fast or slow beating of the heart, a feeling of trembling in the
heart
• facial flushing
• spasms of the tubes from the gall bladder or urinary bladder
• difficulty in passing water
• a reduction in sex drive
• a reduction in body temperature
• dependence on methadone.
This product contains sunset yellow which may cause allergic
reaction
If any of the side effects get serious or you notice side effects not
listed in this leaflet please contact your doctor or pharmacist.

5. Storing Methadone oral solution
Keep out of the reach and sight of children.
This product has an expiry date on the bottle label. This will have
been checked by your pharmacist or doctor. If you have a product
that has passed the given expiry date, return it to your pharmacist
or doctor for safe disposal. Once you have opened the bottle you
are advised to dispose of it after 4 weeks.
Store below 25°C.

6. Further information
What Methadone oral solution contains:
The active ingredient is Methadone Hydrochloride 1mg in 1ml.
The other ingredients are Maltitol liquid, Hydrochloric acid,
sodium benzoate (E211), purified water and colours E110 (sunset
yellow FCF), E142 (green S) and quinoline yellow (E104).
What Methadone oral solution looks like and the contents of
the pack:
Methadone oral solution is a bright green liquid, supplied in
amber glass bottles, each containing 500, 100, 50 or 30ml of the
solution, or it is supplied in HDPE plastic bottles, each containing
5L, 2.5L, 1L or 500ml.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharma, Bampton Road, Harold Hill, Essex RM3 8UG,
UK
Product licence number: PL 00156/0321
Date of Revision: January 2014
If this leaflet is difficult to see or read, please contact the
marketing authorisation holder for help.

In the event of overdose you should seek medical assistance
immediately even if you feel well as you may be suffering
methadone poisoning.
D02775

• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or
pharmacist
• This medicine has been prescribed for you personally and
you should 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 notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist

Driving and using machinery
The ability to drive or use machinery may be severely affected
during and after treatment with methadone. You must not drive or
use machinery until you are told that you can do so by your doctor.
This 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
• 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.
Important information about some of the ingredients
Methadone oral solution contains:
• Colouring agent E110 which may cause an allergic reaction.

2775-B

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02775
Paper size: 170 x 30mm
Version Control Date

By

Version A Created 30/01/14 AC
Version B

03/02/14 AC

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Grand Fromage Creative Ltd
Amherst House, 22 London Road
Sevenoaks, Kent TN13 2BT
t:+44 (0)1732 456 187
e:alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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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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