PATIENT INFORMATION: LEAFLET FOR THE USER

Methadone Hydrochloride DTF (Sugar Free) 1mg/1ml Oral Solution

Contains Methadone Hydrochloride 1mg/1ml

The name of your medicine is Methadone Hydrochloride DTF (sugar free) 1mg/1ml Oral Solution, which will be referred to as

Methadone Solution throughout the rest of this document.

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 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 effect not listed in the leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What is Methadone Solution and what is it used for?

2.    Before you take Methadone Solution

3.    How to take Methadone Solution

4.    Possible side effects

5.    How to store Methadone Solution

6.    Further information

1.    WHAT IS METHADONE SOLUTION AND WHAT IT IS USED FOR

The name of your medicine is Methadone Hydrochloride DTF (sugar free) 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride.

The product is used to treat opioid drug addiction and to treat moderate to severe pain.

2.    BEFORE YOU TAKE METHADONE SOLUTION

Do not take Methadone Solution if:

•    you are allergic (hypersensitive) to methadone or any other

ingredients in this liquid (see section 6 for all of the ingredients). An allergic reaction can include a rash, itching or shortness of breath

•    you are having 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')

•    you are dependent on any other drugs including alcohol

•    you are in labour.

•    you are at risk of developing an obstruction of the intestine.

•    you have a head injury and the pressure inside your brain is higher than it should be. You may be getting bad headaches.

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 methadone.

Take special care with Methadone Solution

Before you take this medicine, tell your doctor if:

•    you have a history of asthma or breathing difficulties

•    you have liver or kidney problems

•    you have epilepsy

•    you have or have recently had a head injury

•    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. 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 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 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

•    rifampicin, used to treat tuberculosis (TB)

•    medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone

•    medicines to stop you feeling sick (metoclopramide or domperidone)

•    medicines to treat heart irregularities (mexiletine)

•    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

•    other opioid drugs (e.g. morphine)

•    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 or you are taking any other medicines, talk to your doctor before taking Methadone Solution. In these situations your doctor may decide to monitor your heart with an electrocardiogram (ECG) at the start of the treatment to ensure these effects do not occur.

Pregnancy and breast-feeding

•    If you are pregnant, think you might be pregnant or intend to become pregnant, speak with your doctor before using this medicine.

•    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

•    it is not recommended to breast-feed if you are taking Methadone Solution.

Driving and using machines

Methadone 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.

Important information about what is in Methadone Solution:

This medicine contains colours - quinoline yellow (E104) and sunset yellow (E110).

These may cause allergic reactions.

3. HOW TO TAKE METHADONE SOLUTION

Always take Methadone Solution exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Under no circumstances should you inject this medicine as injecting it may cause serious and permanent damage to your body with possibly fatal consequences.

Using this medicine

This medicine contains 1mg of methadone in each 1ml and should be taken by mouth

Adults

For addiction

•    the starting dose is 10mg to 20mg (10ml to 20ml) each day

•    the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day until you show no signs of withdrawal or intoxication.

For pain

•    the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours

•    the dose may be changed by your doctor.

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 Solution than you should

•    talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you

•    the signs you may notice are difficulty in breathing; feeling very drowsy which may lead to a stupor or coma; very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness. In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart attack which could lead to death.

If you forget to take Methadone Solution 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 using Methadone Solution

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.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Methadone Solution 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 Methadone Solution.

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.

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

•    worsening 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)

•    constipation

•    sweating a lot more than usual

•    feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure

•    small pupils

•    breast growth and production of breast milk

•    difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms

•    dry mouth, eyes or nose, facial flushing

•    feeling drowsy, confused or restless

•    changes in your mood, feeling “high” or over excited

•    seeing or hearing things that are not there (hallucinations)

•    headache, rashes

•    low body heat (hypothermia)

•    lower sexual urge or desire

•    painful 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 solution.

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.

5. HOW TO STORE METHADONE SOLUTION Keep out of the reach and sight of children

Do not use Methadone Solution after the expiry date which is stated on the label. The expiry refers to the last day of that month. Once you have opened the bottle you are advised to dispose of it after 4 weeks.

•    Store in an upright position.

•    Store below 25°C

•    Do not refrigerate

•    Protect from light

If it is out of date or you no longer want it, take it back to the pharmacy

Do not use Methadone Solution 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.

6. FURTHER INFORMATION

What Methadone Solution contains

The active ingredient is Methadone Hydrochloride.

Each 1ml of solution contains 1mg of methadone hydrochloride.

The other ingredients are lycasin, potassium sorbate, hydrochloric acid, quinoline yellow (E104), sunset yellow (E110), green s (E142) and purified water.

What Methadone Solution looks like and contents of the pack

The appearance of the product is a green solution supplied in an amber glass bottle containing 500ml of solution.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation is held by:

Ayrton Saunders Ltd,

9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU,

UK

The medicine is made by Pharmasol Ltd,

North Way,

Walworth Industrial Estate,

Andover,

Hampshire,

SP10 5AZ,

UK

This leaflet was revised April 2012

If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help quoting product licence number PL 16431/0183

25.04.2012 420x297 mm

Font Arial (regular, bold), size 9 pt, leading 13 pt