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

Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

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 only 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 Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for


• 2. Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution


• 3. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution


• 4. Possible side effects


• 5. How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution


• 6. Further information

What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for

The name of your medicine is Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Methadone is used:

• to treat opioid drug addiction


• to treat moderate to severe pain

Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Do not take Methadone Solution and tell your doctor if:

• you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath


• you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), 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


• you are in labour


• 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 liver or kidney problems


• you have epilepsy


• you are addicted to alcohol


• 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.

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

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 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


• 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, talk to your doctor before taking Methadone Solution.

Taking Methadone Solution with food and drink

Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and Breast-feeding

• talk to your doctor before taking Methadone Solution if you are pregnant or likely to become pregnant


• 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


• do not 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:

• methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine


• liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.

How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine

• this medicine contains 1mg of methadone in each 1ml


• take this medicine 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.

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

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

If you forget to take Methadone Solution

• if you forget a dose do not take it. 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 taking 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Methadone 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.

How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

• Keep out of the reach and sight of children


• Store below 25°C. Protect from light


• Do not use after the expiry date (month, year) stated on the label and carton


• 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.

Further information

What Methadone Solution contains

• The active ingredient is methadone hydrochloride


• The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965), patent blue (E131) and purified water.

What Methadone Solution looks like and contents of the pack

• A green solution.

It comes in a brown glass bottle holding 30ml, 40ml, 50ml, 100ml or 500ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd.

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last approved in December 2009

P0492