PATIENT INFORMATION LEAFLET

Methadone 1mg/ml Oral Solution B.P. Sugar Free

(Methadone Hydrochloride 1mg/ml)

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

•    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.

In this leaflet

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

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

The name of your medicine is Methadone 1mg/ml Oral Solution B.P. Sugar Free. It is a solution to be swallowed and is intended for adult use only.

What is it for?

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.

2. Before you take the medicine

Do not take the medicine if you:

•    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.

Children must not be given this medicine.

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

•    Heart disease or other heart problems such as angina.

•    Liver disease, including Hepatitis C.

•    Kidney disease.

•    Problems with your thyroid gland.

•    Enlargement of your prostate gland.

•    Hormonal problems.

•    A family history of sudden death.

•    Low levels of potassium or magnesium in your blood.

•    Asthma.

•    Or if you are elderly, or extremely ill, as these people can react differently to thismedicine.

•    Epilepsy.

•    Low blood pressure.

•    Shock.

•    Problems withyour adrenal glands.

•    Bowel problems.

•    Muscle weakness problems called myasthenia gravis.

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.

•    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.

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

•    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.

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

•    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.

Pregnancy and breast feeding

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.

Use by children (Age 12 and below)

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

Driving and using machinery

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.

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

◦    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

◦    It wasnotaffecting 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.

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