PACKAGE LEAFLET: INFORMATION FOR THE USER

This product is available using the above name Lioresal 10mg Tablets but will be referred to as Lioresal Tablets throughout this leaflet.

What you need to know about Lioresal Tablets

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 Tablets are and what they are used for

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

3.    How to take Lioresal Tablets

4.    Possible side effects

5.    How to store Lioresal Tablets

6.    Further information

1.    What Lioresal Tablets are and what they are used for

Lioresal Tablets contain 10mg of the active ingredient baclofen.

Baclofen is a muscle-relaxant drug. Lioresal Tablets are 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 Tablets

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

■    you think you may be allergic to baclofen or to any of the other ingredients of the tablets, (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 Tablets:

■    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 wheat flour? (The tablets

contain small amounts of wheat starch. They are suitable for people with coeliac disease, however if you have a wheat allergy (different from coeliac disease), you should not take this medicine.)

If the answer to any of these questions is YES, tell your doctor or pharmacist because Lioresal Tablets 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

■    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 Tablets 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 Tablets passes into breast milk. Your doctor will discuss with you whether you should breastfeed whilst taking Lioresal Tablets.

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 Tablets. 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

■    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 Tablets.

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

Children and adolescents:

Lioresal Tablets are not suitable for use in children under 33kg body weight.

3. How to take Lioresal Tablets

The doctor will tell you how many Lioresal Tablets to take and when to take them. 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 Tablets 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 Tablets suddenly. If the doctor decides to stop your treatment with Lioresal Tablets, 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 Tablets, you may find it helps to take them with food or a milk drink.

Adults

■    The usual dose is 20mg (2 tablets) three times a day.

■    The maximum daily dose is 100mg (10 tablets) except if you are in hospital when a higher dose may be used.

Children (0 to < 18 years)

Children's treatment is adjusted to their body weight. Children's treatment usually starts with a very low dose (approximately 0.3mg/kg/day), in 2-4 divided doses (preferably in 4 doses). The dosage is then gradually increased until it becomes sufficient for the child's individual requirements, this may be between 0.75 and 2mg/kg body weight. The total daily dose should not exceed a maximum of 40mg/day in children below 8 years of age. In children over 8 years of age a maximum daily dose of 60mg/day may be given. Lioresal Tablets are not suitable for use in children below 33kg body weight.

Patients with kidney problems

You will probably be given a much lower dose. The doctor will decide what the dose should be.

What if you forget to take a dose?

If you forget to take a dose, take the next dose at the usual time. dO NOT take a double dose.

What if you take too much?

If you accidentally take too many Lioresal Tablets, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.

4. Possible side effects

Lioresal Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

The side effects listed below have been reported:

More than 1 in 10 people have experienced:

Tiredness, sleepiness, nausea (feeling sick).

Up to 1 in 10 people have experienced:

Excessively weak limbs or feeling tired and exhausted, aching muscles

Headache, dizziness or light-headedness

Breathing difficulties

Sleeplessness

Mood changes, confusion, hallucinations or nightmares Dry mouth

Problems with their eyes

Unsteadiness, trembling or other problems with muscle control Low blood pressure (fainting)

Stomach problems including retching, vomiting, constipation and diarrhoea

Excessive sweating, rash

Increased need to pass urine or pain on passing urine.

Up to 1 in 1,000 people have experienced:

Numbness or tingling in hands or feet

Increased muscle spasm

Disturbed sense of taste

Slurred or slow speech

Stomach ache

Liver problems

Difficulty in passing urine

Sexual problems in men, e.g. impotence

Convulsions (particularly in epileptics).

Very rarely (less than 1 in 10,000) people have experienced:

Hypothermia (low body temperature).

Other side-effects (how often they happen is not known)

Raised, itchy rash (urticaria - also known as nettle rash or hives). Slow heart beat.

Increase in blood sugar.

Symptoms caused by stopping treatment suddenly (see '3. How to take Lioresal Tablets').

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to adjust the dose or give you a different medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Lioresal Tablets

■    The expiry date for these tablets is given on the carton. Do not use after this date.

■    Do not store above 25°C. Protect from heat and moisture.

■    Keep out of the sight and reach of children.

■    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.

■    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

6.    Further information

What Lioresal Tablets contain

Each tablet contains 10mg of baclofen.

Lioresal Tablets also contain the following inactive ingredients: silicon dioxide, microcrystalline cellulose, magnesium stearate, povidone and wheat starch.

What Lioresal Tablets look like and contents of the pack

The tablets are white or faintly yellow, round, flat with bevelled edges and are coded 'CG' on one side and 'KJ' and a breakline on the reverse.

Lioresal Tablets are available as blister packs of 60 tablets.

Manufacturer

This product is manufactured by: Novartis Farma S.p.A., Via Provinciale Schito, 131, 80058 Torre Annunziata, Napoli, Italy.

Or

Novartis Farma, Estrada de Casais, Alto do Forte 2735 Rio de Mouro, Portugal.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 04423/0194 POM

LIORESAL® is a registered trademark of Novartis AG.

Leaflet revision and issue date (Ref): 03.07.15

To request a copy of this leaflet in Braille, large print or audio please call 01302 552940 and ask for the Regulatory Department.

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