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METHADONE MIXTURE 1MG/ML

Active substance(s): METHADONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Methadone Mixture 1mg/ml
(Methadone Hydrochloride)

Proof No.

1

Date

01.03.2016

23633912

01.03.2016
Date

The medicine can affect your ability to drive as it may make you sleepy
• Heart disease or other heart problems such as angina.
or dizzy.
• Liver disease, including Hepatitis C.
• Kidney disease.
• Do not drive while taking this medicine until you know how it affects
• Problems with your thyroid gland.
you.
• Enlargement of your prostate gland.
• It is an offence to drive if this medicine affects your ability to drive.
• Hormonal problems.
• However, you would not be committing an offence if:
• A family history of sudden death.
◦ The medicine has been prescribed to treat a medical or dental
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• Low levels of potassium or magnesium in your blood.
problem and
• Asthma.
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◦ You have taken
it according
to the instructions given by the prescriber
Methadone Mixture 1mg/ml
• OrProduct
if you Title
are elderly, or extremely ill, as these people can react
or in the information provided with the medicine and
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differently to this medicine.
◦ It was not affecting your ability to drive safely.
• Epilepsy.
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Leaflet
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• Low blood pressure.
Talk to your doctor or pharmacist if you are not sure whether it is safe
Pack Size
500ml
• Shock.
for you to drive while taking this medicine.
• Problems
adrenal glands.
IG Code with your
23633912
• Bowel problems.
Turn over
x 297mm
flat (105mm
x 148mm
folded)
Dimensions
• Muscle
weakness210mm
problems
called
myasthenia
gravis.

1

This medicine may make you drowsy. If affected do not drive or
operate machinery. People are affected differently so your doctor will
advise you when it is safe to drive again.

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Driving and using machinery

210mm x 297mm flat (105mm x 148mm folded)

Children should not take this medicine as they may be at greater risk
from its effects.

Dimensions

Use by children (Age 12 and below)

23633912

Talk to your doctor or pharmacist if you have any of the
following:

When pregnant it is especially important that you follow the instruction
for treatment given by your doctor or clinic. Do not use this medicine
whilst in labour. Talk to your doctor before breast feeding.

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Children must not be given this medicine.

Pregnancy and breast feeding

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• Are also taking heroin and/or other illegal substances.
• Are dependent on any other non opioid drugs.
• Are allergic to any of the ingredients listed under ‘further
information’.
• Have shallow breathing or other breathing difficulties. Do not use
during an asthma attack.
• Have taken antidepressants known as Monoamine Oxidase Inhibitors
(MAOIs) including moclobenide within the past two weeks.
• Have or have recently had a head injury.
• Are at risk of a type of blocked bowel called paralytic ileus following
abdominal surgery.
• Are addicted to alcohol.
• Are in labour.
Ask your doctor for advice if any of these apply to you.

500ml

Do not take the medicine if you:

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2. Before you take the medicine

• Other Methadone products or buprenorphine.
• Cimetidine for stomach ulcers or heartburn.
• Drugs for the treatment of HIV infection (known as CYP 3A4
inhibitors).
• The antibiotic medicine Ciprofloxacin.
• Medicines for fungal infections.
• Drugs which make the urine more alkaline, including potassium
citrate.
• Fluvoxamine, a medicine used to treat depression.
Ask your doctor if you are unsure if any of these apply.

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The product works to prevent withdrawal symptoms in people who are
addicted to opioid drugs such as heroin. It is important that it is taken
regularly to reduce the risk of withdrawal symptoms occurring.

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The doctor may need to reduce the dose of Methadone if
taking these medicines:

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What is it for?

The name of your medicine is Methadone Mixture 1mg/ml. It is a
solution to be swallowed and is intended for adult use only.

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1.  What is the medicine and
what does it do?

• Rifampicin for tuberculosis.
• Phenytoin, Phenobarbital or Carbamazepine for epilepsy.
• Some drugs used for the treatment of HIV infection including
Nevirapine, efavirenz and abacavir.
• Drugs which make the urine more acid, including ammonium
chloride.

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The doctor may need to increase the dose of Methadone if
taking these medicines:

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1. What is the medicine and what does it do?
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. How to store the medicine
6. Further information

Methadone Mixture 1mg/ml

In this leaflet

• Alcohol on a regular basis, including binge drinking (See Section 3).
• Any drugs which affect the heart.
• Drugs which affect the salt levels in your body.
• Desipramine or other drugs for depression.
• Medicine for mental illness.
• Painkillers (other than Methadone).
• Sleeping tablets/mixtures or any other tranquillisers.
• Naloxone or naltrexone for drug or alcohol addiction.
• Metoclopramide or domperidone to stop feeling or being sick.
• Zidovudine, didanosine or stavudine for the treatment of HIV
infections.

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• 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.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Also talk to your doctor or pharmacist if you are already
taking any of the following:
These medicines may have a different effect when taking
Methadone.

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Read all this leaflet carefully before you
start taking this medicine.

Important information about some of the ingredients of this
medicine
This medicine contains 8.8g of sucrose per 20ml dose. This should
be taken into account in patients with diabetes mellitus. It contains
colouring agents (E102 and E110) which may cause allergic reactions.

3. How to take the medicine

This medicine has been prescribed for you personally. Do not
pass it on to others as it may harm them.
Dose: Always take your medicine as prescribed by your doctor. The

usual starting dose is 2 to 4 x 5ml spoonfuls by mouth daily, but doctors
sometimes prescribe different doses to this. Follow the doctor’s
instructions carefully. The dose should be taken all at once and
preferably at the same time every day.
If you take too much see a doctor straight away.

Effects when taken with alcohol or illegal substances

The risk of overdose and serious harm is greatly increased if taken with
alcohol, heroin and/or other illegal substances. Do not mix these with
your Methadone.

Effects when treatment is stopped

Stopping this medication abruptly will cause side effects, possibly
severe. Follow the doctor’s instructions carefully for coming off this
medicine gradually.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.
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 the medicine

Do not store above 25°C.
Keep out of the sight and reach of children.
Keep the medicine in a locked cupboard if possible.
Do not use the medicine after any expiry date which may appear on the
label. Medicines should not be disposed of via wastewater or household
waste. Return any unused medicine to your pharmacist. These measures
will help protect the environment.

6. Further information
What the medicine contains

The active substance is methadone hydrochloride 1mg per ml.
The other ingredients are benzoic acid solution (E210, propylene
glycol), syrup, tartrazine (E102), sunset yellow (E110), green S dye
(E142) and purified water.

What the medicine looks like

The medicine is a green coloured liquid.

4. Possible side effects

Marketing Authorisation Holder and Manufacturer

Like all medicines, Methadone 1mg/ml can have side effects although
not everybody gets them.

This leaflet was last revised in March 2016

Thornton and Ross Ltd., Huddersfield, HD7 5QH, England.

Important side effects:

• Shallow breathing. This may lead to unconsciousness and death.
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An allergic reaction which may include:
• Swelling of your face, lips, tongue or throat or difficulty breathing or
swallowing.
• Severe itching of your skin with raised lumps or rash.

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If you think you have the following serious side effects or symptoms,
stop taking this medicine immediately and see a doctor straight away.

01.03.2016
Date

1

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Proof No.

23633912

210mm x 297mm flat (105mm x 148mm folded)

01.03.2016

Dimensions

Date

23633912

1

500ml

Proof No.

IG Code

210mm x 297mm flat (105mm x 148mm folded)

Leaflet

Dimensions

Pack Size

23633912

Component

IG Code

Times New Roman

Methadone Mixture 1mg/ml

Black
If any of the side effects gets serious or you notice any side Process
effect not
Component
Leaflet
included above, please tell your doctor or pharmacist straightKeyline
away.(non-printing)
They
what to do.
Packwill
Sizetell you500ml

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• Pinpoint pupils.
• Low blood pressure on standing up, facial flushing.
• Worsening of existing asthma.
• Nausea, vomiting, constipation and dry mouth.
• Hallucinations, confusion, mood changes, anxiety, depression, lower
sexual urge or desire.
• Increase in pressure within the head, particularly if pressure is already
raised for other reasons, dizziness/vertigo, headache and drowsiness.
• Difficulty in passing water (urine), passing less water (urine) than
usual.
• Reduction in the body’s normal production of adrenal hormones.
• Low body heat (hypothermia).
• Abnormal rapid, slow, or irregular heartbeat.
• Pain in the lower back and abdomen caused by muscle spasms.
• When taken for a long period of time, it is possible that you may
become dependent on Methadone Mixture. Long term use may cause
excessive sweating and irregularities in the make-up of the blood
(increased
number
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Box of white blood cells, increased protein or antibody
levels). Erectile function, ejaculate volume and testosterone levels
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may be reduced Methadone
in men. Mixture 1mg/ml

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Other possible side effects:

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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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