1

Ciba

LIORESAL® Liquid

(baclofen)

Patient Information Leaflet

What you need to know about Lioresal Liquid

Your doctor has decided that you or your child need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don't understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Lioresal Liquid is and what it's used for

2. Things to consider before you start to take Lioresal Liquid

3. How to take Lioresal Liquid

4. Possible side effects

5. How to store Lioresal Liquid

6. Further information

1. What Lioresal Liquid is and what it's used for

Lioresal Liquid is a syrup containing 5 mg of the active ingredient, baclofen, in each 5 ml.

Baclofen is a muscle-relaxant drug. Lioresal Liquid is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular

accidents, spinal cord diseases and other nervous system disorders.

2. Things to consider before you start to take Lioresal Liquid

Some people MUST NOT take Lioresal Liquid. Talk to your doctor if:

•    you think you may be allergic to baclofen or to any of the other ingredients of the liquid, (These are listed at the end of the leaflet.)

•    you have ever had a stomach ulcer.

You should also ask yourself these questions before taking Lioresal Liquid:

•    Have you had a stroke?

•    Do you have epilepsy?

•    Do you suffer from any mental illness?

•    Are you being treated for high blood pressure?

•    Do you have Parkinson's disease?

•    Do you suffer from any liver, kidney or lung disease?

•    Do you have diabetes?

•    Do you have difficulties in urinating?

•    Are you pregnant or breast feeding?

•    Do you have an intolerance to some sugars? (The liquid contains sorbitol.)

If the answer to any of these questions is YES, tell your doctor or pharmacist because Lioresal Liquid might not be the right medicine for you.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

•    Other medicines to relax muscles e.g. tizanidine

•    Medicines to treat mood disorders such as lithium or tricyclic antidepressants such as amitriptyline

•    Medicines for high blood pressure e.g. diltiazem

•    Other drugs which also affect the kidney, e.g. ibuprofen

•    Medicines for Parkinson's disease e.g. levodopa or carbidopa

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•    Medicines which slow down the nervous system, e.g. anti-histamines such as promethazine, sedatives such as temazepam, opiates for pain relief such as morphine and anti-convulsants (anti-epileptic medicines such as carbamazepine).

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should not use Lioresal during pregnancy unless your doctor advises you to do so. Tell your doctor if you are pregnant, or planning to become pregnant.

Only a very small amount of Lioresal passes into breast milk. Your doctor will discuss with you whether you should breast-feed whilst taking Lioresal.

Will there be any problems with driving or using machinery?

Some people may feel drowsy and/or dizzy or have problems with their eyes while they are taking Lioresal Liquid. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until these effects have worn off.

Other special warnings

•    Lioresal Liquid contains

1.Small amounts of the preservatives methyl and propyl hydroxybenzoate. These can sometimes cause allergic reactions which might appear some time after first taking the medicine.

2.Sodium 1.6mg/mL. Take this into consideration if you are on a controlled sodium diet.

3.Sorbitol. This can have a mild laxative effect and you might be affected if you take more than 25 ml of Lioresal Liquid per day. Calorific value 2.6 kcal/g sorbitol.

•    Be careful when drinking alcohol - it may affect you more than usual.

•    Your doctor may want to give you a check up from time to time while you are taking Lioresal Liquid.

•    If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Lioresal Liquid.

3. How to take Lioresal Liquid

The doctor will tell you how much Lioresal Liquid to take and when to take it. Always follow his/her instructions carefully. The dose will be on the pharmacist's label. Check the label carefully. If you are not sure, ask your doctor or pharmacist.

The doctor will tell you the best time to take the medicine. Some people take it only at night or before doing a task such as washing, dressing, shaving, etc.

The final dose of Lioresal depends on how each person responds to the drug. You will be started on a low dose, and this will be increased gradually over a few days, under the supervision of the doctor, until you are having the dose which is right for you. If the starting dose is too high, or if the dose is increased too quickly, you may experience side effects, particularly if you are elderly, have kidney problems or have had a stroke.

You should not stop taking Lioresal Liquid suddenly. If the doctor decides to stop your treatment with Lioresal Liquid, the dose will be reduced gradually to prevent withdrawal symptoms such as muscle spasms and increased muscle rigidity, fast heart rate, fever, confusion, hallucinations, changes in mood and emotion, mental disorders, feeling persecuted or convulsions (fits).

If you feel sick after taking Lioresal Liquid, you may find it helps to take it with food or a milk drink.

Adults

•    The usual dose is 20 mg (20 ml) three times a day.

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5.    How to store Lioresal Liquid

Keep all medicines out of the reach and sight of children.

Store the elixir below 25°C. Protect from light. Do not refrigerate. Any syrup which has been diluted with water can be stored at room temperature for up to 14 days.

Do not take the elixir after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Lioresal Liquid, please take any which is left back to your pharmacist to be destroyed. Only keep it if the doctor tells you to. Do not throw it away with your normal household water or waste. This will help to protect the environment.

6.    Further information

Lioresal Liquid is clear, slightly yellow syrup with a raspberry flavour containing 5 mg of the active ingredient, baclofen, in each 5 ml. The liquid also contains the inactive ingredients sorbitol, methyl and propyl hydroxybenzoate, carmellose sodium, raspberry flavour and water.

The liquid comes in 300 ml bottles with child-proof closures.

The product licence holder is Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England.

Lioresal Liquid is manufactured by Novartis Pharmaceuticals UK Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.

This leaflet was revised in May 2015.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370. LIORESAL is a registered trade mark Copyright Novartis Pharmaceuticals UK Limited

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