RILUTEK 50 mg film-coated tablets

What RILUTEK is

The active substance in RILUTEK is riluzole which acts on the nervous system.

What RILUTEK is used for

RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).

ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.

The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord. RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.

Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.

Do not take RILUTEK

• if you are allergic (hypersensitive) to riluzole or any of the other ingredients of RILUTEK,
• if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
• if you are pregnant or breast-feeding.

Take special care with RILUTEK

Tell your doctor;

• if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick
• if your kidneys are not working very well
• if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection
• if you are less than 18 years of age. The use of RILUTEK is not recommended in children because there is no information available in this population. If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast feeding.

If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.

Driving and using machines

You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.

The recommended dose is one tablet, twice a day.
The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).

If you take more RILUTEK than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take RILUTEK

If you forget to take your tablet, leave out that dose completely and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten tablet.

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

Like all medicines, RILUTEK can cause side effects, although not everybody gets them.

IMPORTANT
Tell your doctor immediately

• if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells. Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
• if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
• if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).

Very common side effects (affecting more than 1 in 10 patients) of RILUTEK are:

• tiredness
• feeling sick
• increased blood levels of some enzymes of the liver (transaminases).

Common side effects affecting between 1 in 10 and 1 in 100 patients of RILUTEK are - - - dizziness sleepiness headache - - - numbness or tingling of the mouth increase in heart beat abdominal pain - - - vomiting diarrhoea pain

Uncommon side effects (affecting between 1 in 100 and 1 in 1000 patients) of RILUTEK are:

• anaemia
• allergic reactions
• inflammation of the pancreas (pancreatitis).

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.

Keep out of the reach and sight of children.

Do not use RILUTEK after the expiry date which is stated on the carton and the blister.

What RILUTEK contains

• The active substance is riluzole.
• The other ingredients are: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium; Coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What RILUTEK looks like and content of the pack

The tablets are film-coated, capsule-shaped and white. Each tablet contains 50 mg of riluzole and is engraved with ?RPR 202? on one side.
RILUTEK is available in a pack of 56 tablets (4 blister cards of 14 tablets each) to be taken orally.

Marketing Authorisation Holder

Aventis Pharma S.A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France

Manufacturer

Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgique Belgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien

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eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022

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Deutschland Sanofi-Aventis Deutschland GmbH Tel 49 0180 2 222010 Norge sanofi-aventis Norge AS Tlf 47 67 10 71 00

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Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

This leaflet was last approved in {MM/YYYY}.