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■    Do not take it for a longer time than your doctor prescribes it.

■    Take this medicine by mouth.

■    The strength of this liquid is 1 mg (milligram) in each ml.

If you feel that the effect of Eptadone is too strong or too weak, talk your doctor or pharmacist.

For drug addiction

■    The usual dose is 10 to 20 mg (10 to 20 mis) each day

•    The dose may increase to between 40 and 60 mg (40 to 60 ml) each day.

This will depend on how the medicine affects you

■    Always take the dose prescribed by your doctor.

For moderate to severe pain

•    The usual dose is 5 to 10 mg (5 to 10 mis), every 6 to 8 hours

■    Your doctor may change the amount you take each day. This will depend on how the medicine affects you.

If you take more Eptadone than you should

If you take more Eptadone than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you.

The following effects may happen:

■    problems breathing ■ feeling very sleepy, nearly unconscious or even in a coma

•    very small pupils in your eyes

•    cold and clammy skin

•    a very slow pulse

*    muscle weakness.

In extreme cases your breathing or blood flow may stop and you may have a heart attack. If you forget to take Eptadone

*    If you forget a dose, do not take this medicine when you remember.

*    Wait until the next dose is due and take only one dose. Do not double the dose.

Do not stop taking Eptadone without talking to your doctor first

This is because you may get side effects. If you need to stop taking Eptadone, your doctor will slowly stop it.

Possible side effects

Like all medicines, Eptadone can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Very Common (affects more than 1 in 10 people)

■ breathing problems or asthma made worse

* headache, feeling weak, sleepy or confused, difficulty sleeping, feeling restless or irritable or changes in your mood, feeling empty-headed

■    problems with your sight or your pupils getting smaller (miosis)

■    feeling sick (nausea), being sick (vomiting), constipation, dry mouth or loss of appetite

■    low blood pressure and feeling dizzy (especially when you stand up), slower heart rate, faster or uneven heart beats (palpitations)

* increased pressure inside your brain, particularly if you already have this problem

■    difficulty in passing water, pain in your stomach area

■    loss of sex drive or sexual impotence

■    excessive sweating, flushing of your face or itching.

Uncommon (affects less than 1 in 100 people)

■    extreme weakness leading to your heart stopping

■    changes in a test called an electrocardiogram or ‘ECT’

■    bleeding inside the body

■    increased levels in the blood of a hormone called prolactin.

You may notice that some of the side effects become less severe with time.

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 Eptadone

Keep the bottle in the outer carton (20ml, 40ml, 60ml and 100ml container) or store in the original package (1000ml).

■    Keep out of the reach and sight of children.

■    Do not use this medicine after the expiry date (month, year) stated on the container.

■    Once the bottle is opened, you should use the 100ml and 1000ml containers within 12 months.

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 Eptadone contains

■    The active substance is methadone hydrochloride. Each 1 ml of Eptadone contains 1 milligram of methadone hydrochloride.

■    The other ingredients are sucrose, glycerol, citric acid monohydrate, lemon flavour (including Citropten, Citral, and ethanol), sodium benzoate, tartrazine (E102), brilliant blue (E133) and purified water.

Eptadone 1 mg/ml is a green solution for oral use.

It is available in the following packs:

•    1 mg/ml oral solution in a 20ml single-dose container. Each bottle contains 20mg methadone hydrochloride

•    1 mg/ml oral solution in 40ml single-dose container. Each bottle contains 40mg methadone hydrochloride

•    1 mg/ml oral solution in 60ml single-dose container. Each bottle contains 60mg methadone hydrochloride

•    1 mg/ml oral solution in 100ml and 1000ml multidose containers, with measuring cup. Each bottle contains 100mg and 1000mg, respectively.

Marketing Authorisation Holder and Manufacturer:

L. Molteni & C. dei F.lli Alitti Society di Esercizio SpA- Strada Statale 67, Fraz. Granatieri - 50018 Scandicci (Firenze) - Italy

For any information about this medicine, please talk to the Marketing Authorisation Holder.

Distributed in the UK by:

Dee Pharmaceuticals Ltd, Office 3K6 Redwither Tower, Redwhiter Business Park, Wrexham LL13 9XT - Tel / Fax: +44(0)1978661993

This leaflet was last revised in August 2010.

Package Leaflet: Information for the user

Eptadone® 1 mg/ml oral solution Methadone hydrochloride

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, please 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 effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Eptadone is and what it is used for

2.    Before you take Eptadone

3.    How to take Eptadone

4.    Possible side effects

5 How to store Eptadone 6. Further information

1._What Eptadone is and what it is used for

Eptadone contains a medicine called methadone. This belongs to a group of medicines which act on your nervous system like morphine and diamorphine (also called heroin). They are sometimes called ‘opiates’. Eptadone is a liquid medicine which should only be taken by your mouth.

Eptadone is used:

■    to treat addiction to medicines like morphine or heroin (opiates). It acts as a substitute for the addictive drugs. Eptadone is addictive and may cause symptoms of dependence but it is less addictive than medicines like heroin or morphine.

■    to treat moderate to severe pain.

Before you take Eptadone

Do not take Eptadone if:

■    you are allergic (hypersensitive) to methadone hydrochloride or any of the other ingredients of Eptadone (listed in section 6)

■    you are addicted to medicines which are not like morphine or heroin (‘opiate’ medicines)

* you have ever had breathing or lung problems such as asthma or COPD

■    you are having an asthma attack

■    you are going into labour or are in labour

■    you are a child.

Do not take Eptadone if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Eptadone.

Take special care with Eptadone

Check with your doctor or pharmacist before taking your medicine if:

*    you have kidney problems

*    you have liver problems

*    you have a severe headache or have recently had a head injury

*    you have a raised pressure inside your skull

*    you have heart problems, such as a problem with the way your heart beats

*    you have been told by your doctor that you have an ‘electrolyte imbalance’ such as ‘hypokalaemia’

*    you have low blood pressure

*    you are in shock (you may have a very low blood pressure which can lead to collapse)

*    you have an under-active thyroid gland

*    you have a ‘hyper-active adrenal gland’

*    you are a man who has prostate problems

*    you are elderly (over 65 years of age).

*    you are generally unwell.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Eptadone.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Eptadone can affect the way some medicines work. Also some other medicines can affect the way Eptadone works.

Do not take this medicine, and tell your doctor, if you are taking:

■    medicines for depression called MAOIs (MonoAmine Oxidase Inhibitors)

or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine and tranylcypromine.

Tell your doctor if you are taking any of the following medicines:

■    medicines for fungal infections such as fluconazole, itraconazole or ketoconazole

■    medicines for epilepsy such as barbiturates, phenytoin or carbamazepine

■    medicines for diarrhoea such as loperamide or co-phenotrope

■    medicines that make your urine acid such as ammonium chloride • medicines used to stop opiates working such as naltrexone

■    medicines used to treat addiction such as buprenorphine

■    medicines for depression such as fluoxetine, paroxetine, sertraline, nefazodone or fluvoxamine

■    medicines for HIV such as nevirapine, delavirdine, didanosine stavudine, zidovudine, ritonavir, abacavir or efavirenz

■    antibiotics such as rifampicin, clarithromycin or erythromycin

■    strong painkillers such as morphine, butorphanol, nalbuphine, pentazocine

*    naloxone used to reverse the effects of opiate medicines

■    octreotide used to treat some types of cancer and to reduce secretions

■    verapamil used for heart problems

■    ‘cannabinoids’ used for pain, such as dronabinol and nabilone.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Eptadone.

Taking Eptadone with food and drink

Do not drink alcohol while taking this medicine. This is because alcohol may increase the side effects of methadone such as breathing problems and feeling dizzy because of low blood pressure. Do not drink grapefruit juice while you are taking this medicine. This is because grapefruit juice can change the effect of methadone.

Pregnancy and breast-feeding

*    Do not take Eptadone if you are going into labour or are in labour.

■    Talk to your doctor before taking Eptadone if you are pregnant or likely to become pregnant.

■    Talk to your doctor before taking Eptadone if you are breast-feeding. This is because small amounts may pass into the mother's milk.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines:

Eptadone may make you feel drowsy and less alert and will affect your ability to drive

or use any tools or machines.

*    This will happen while you are taking it, and also for some time afterwards.

*    Only start driving or using tools or machines when your doctor says it is OK.

Important information about some of the ingredients of Eptadone

Eptadone contains:

*    40 grams of sucrose (a type of sugar) in each 100 ml. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. If you have diabetes, you also need to take this into account

*    a small amount of ethanol (alcohol) - less than 100 milligrams in each 100 ml. A10 mg dose of Eptadone will contain 0.01 ml of ethanol.

*    glycerol - when taken in large amounts it may cause headache, stomach upset and diarrhoea.

■ colour - tartrazine (E102). This may cause allergic reactions.

How to take Eptadone

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

*    Do not take more or less than the dose you have been told.

*    Do not take it more or less often than you have been told.