PACKAGE LEAFLET: INFORMATION FOR THE USER

RILUZOLE 50MG FILM-COATED TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What riluzole is and what it is used for

2.    What you need to know before you take riluzole

3.    How to take riluzole

4.    Possible side effects

5.    How to store riluzole

6.    Contents of the pack and other information

1. WHAT RILUZOLE IS AND WHAT IT IS USED FOR What riluzole is

The active substance in Riluzole 50mg film-coated tablets is riluzole which acts on the nervous system.

What riluzole is used for

Riluzole 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. Riluzole 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RILUZOLE Do not take riluzole

-    if you are allergic (hypersensitive) to riluzole or any of the other ingredients of this medicine (listed in section 6),

-    if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),

-    if you are pregnant or breast-feeding.

Warnings and precautions

Talk to you doctor or pharmacist before taking riluzole:

-    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 any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.

Children and adolescents

The use of riluzole is not recommended in children and adolescents less than 18 years of age because there is no information available in this population.

Other medicines and riluzole

Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding

You MUST NOT take riluzole if you are pregnant or breast-feeding or think you may be pregnant.

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

Driving and using machines

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

3. HOW TO TAKE RILUZOLE

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 riluzole than you should

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

If you forget to take riluzole

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 medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

IMPORTANT

Tell your doctor immediately

-    if you experience any fever (increase in temperature) because riluzole 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 riluzole 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 (may affect more than 1 in 10 people) of riluzole are:

-    tiredness

-    feeling sick

-    increased blood levels of some enzymes    of the liver (transaminases).

Common side effects (may affect up to 1 in 10 people) of riluzole are:

-    dizziness    -    numbness or tingling of the    -    vomiting

mouth

-    sleepiness    -    increase in heart beat    -    diarrhoea

-    headache    -    abdominal pain    -    pain

Uncommon side effects (may affect up to 1 in 100 people) of riluzole are:

-    anaemia

-    allergic reactions

-    inflammation of the pancreas (pancreatitis).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet.

5. HOW TO STORE RILUZOLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Riluzole 50mg film-coated tablets contain

The active substance of Riluzole 50mg film-coated tablets is riluzole.

Each film-coated tablet contains 50 mg of riluzole.

The other ingredients are:

Core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;

Coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What Riluzole 50mg film-coated tablets look like and contents of the pack

White, capsule-shaped film-coated tablet, engraved with “RPR 202” on one side.

Riluzole 50mg film-coated tablets are available in a pack of 56 film-coated tablets.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer

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

This leaflet was last revised in October 2012. ’Zentiva’ is a registerd trademark © 2012 Zentiva