RILUTEK 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

RILUTEK 50mg film-coated tablets

Riluzole

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 symptoms 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. See section 4.

Contents of the package leaflet

1. What is RILUTEK and what is it used for
2. What you need to know before you take RILUTEK
3. How to take RILUTEK
4. Possible side effects
5. Storage of RILUTEK
6. Contents of the pack and other information

1. What is RILUTEK and what is it used for

What is RILUTEK

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

What is RILUTEK used for

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

ALS is a type of motor neuron disease that affects the nerve cells responsible for sending signals to the muscles, causing weakness, muscle wasting, and paralysis.

The destruction of nerve cells in motor neuron disease may be caused by excess glutamate (a chemical messenger) in the brain and spinal cord. RILUTEK stops the release of glutamate, which may help prevent damage to nerve cells.

For more information, ask your doctor about ALS and why you have been prescribed this medicine.

2. What you need to know before you take RILUTEK

Do not take RILUTEK

? if you are allergicto riluzole or any of the other ingredients of this medicine (listed in section 6),

? if you have any liver diseaseor high levels of certain liver enzymes (transaminases) in your blood.

? if you are pregnantor breast-feeding.

Warnings and precautions

Talk to your doctor before taking RILUTEK:

• if you have liver problems: yellowing of the skin or whites of the eyes (jaundice), generalized itching, feeling of dizziness, nausea
• if your kidneys do not work properly
• if you have a fever: this may be due to a lower number of white blood cells, which can increase the risk of infection

If any of the above circumstances apply to you, or if you are not sure, tell your doctor who will advise you what to do.

Children and adolescents

If you are under 18 years of age, RILUTEK is not recommended as there is no available information in this population.

Using RILUTEK with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

DO NOT take RILUTEK if you are pregnant or think you may be pregnant, or if you are breast-feeding.

Talk to your doctor before taking RILUTEK if you think you might be pregnant or if you plan to breast-feed.

Driving and using machines

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

RILUTEK contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take RILUTEK

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

The recommended dose is one tablet twice a day.

The tablets should be taken by mouth, every 12 hours, at the same time each day (e.g. in the morning and at night).

If you take more RILUTEK than you should

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

If you forget to take RILUTEK

If you miss a dose, skip this dose and take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

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

Talk to your doctor immediately

• if you have a fever(high temperature) because RILUTEK can cause a decrease in the number of white blood cells. Your doctor may tell you to have blood tests to check the number of white blood cells, which are important for fighting infections.

• if you experience any of the following symptoms: yellowing of the skin or whites of the eyes (jaundice), generalized itching, feeling of dizziness, or nausea, as these may be signs of liver disease(hepatitis). Your doctor will tell you to have regular blood tests while taking RILUTEK to make sure this does not happen.

• if you experience coughing or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).

Other side effects

Very common side effects(may affect more than 1 in 10 people) of RILUTEK are:

• fatigue
• dizziness
• high levels of certain liver enzymes (transaminases) in the blood

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

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

• anemia
• allergic reactions
• inflammation of the pancreas (pancreatitis)

Frequency not known(cannot be estimated from the available data):

• skin rash

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of RILUTEK

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 blister after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

6. Contents of the pack and other information

What RILUTEK contains

• The active substance is riluzole.
• The other ingredients are:

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

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

Appearance and packaging

The tablets are film-coated, white, and capsule-shaped. 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 for oral use.

Marketing Authorisation Holder

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne

France

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder.

This leaflet was approved in (month/year)