RILUTEK

Package leaflet: Information for the user

RILUTEK 50mg film-coated tablets

Riluzole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:
  1. What RILUTEK is and what it is used for
  2. What you need to know before taking RILUTEK
  3. How to take RILUTEK
  4. Possible side effects
  5. How to store 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 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 neuron disease in which damage to the nerve cells responsible for sending signals to the muscles leads to muscle weakness, atrophy, and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by excessive glutamate (a chemical messenger) in the brain and spinal cord. RILUTEK reduces the release of glutamate, which may help prevent nerve cell damage.
Please consult your doctor for further information about ALS and the reason why this medicine has been prescribed to you.

2. What you should know before taking RILUTEK

Do not take RILUTEK

• if you are allergic to riluzole or to any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease or increased blood levels of certain liver enzymes (transaminases),
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor before taking RILUTEK:

• if you have liver problems: yellowing of the skin or the white part of the eye (jaundice),
  itching all over the body, feeling unwell, or nausea
• if your kidneys are not working properly
• if you develop fever: this could be due to a decrease in white blood cells; such a decrease may increase the risk of infections
  If any of the above situations occur, or if you are unsure, consult your doctor, who will decide on the appropriate course of action.

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

Other medicines and RILUTEK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
DO NOT take RILUTEK if you are pregnant or think you might be pregnant, or if you are breastfeeding. If you think you may be pregnant or plan to breastfeed, consult your doctor before taking RILUTEK.

Driving and using machines
You may drive or operate tools and machinery unless, after taking this medicine, you feel dizzy or experience a sensation of light-headedness.

RILUTEK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RILUTEK

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet twice daily.
The tablets should be taken orally, every 12 hours, at approximately the same times each day (for example, 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, skip the missed dose and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use 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
Contact your doctor immediately

• if you develop fever (raised temperature), as RILUTEK may cause a decrease in the number of white blood cells. Your doctor may ask you to have a blood test to check your white blood cell count, which is important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or the whites of the eyes (jaundice), itching all over the body, feeling unwell or becoming unwell, as these may indicate liver disease (hepatitis). Your doctor may perform regular blood tests while you are taking RILUTEK to ensure this does not occur.
• if you develop cough or difficulty breathing, as these may be signs 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
• malaise
• increased blood levels of certain liver enzymes (transaminases)

Common side effects (may affect more than 1 in 100 but less than 1 in 10 people) of RILUTEK are:

• dizziness
• numbness or tingling of the mouth
• vomiting
• somnolence
• increased heart rate
• diarrhoea
• headache
• abdominal pain
• pain

Uncommon side effects (may affect more than 1 in 1,000 but less than 1 in 100 people) of RILUTEK are:

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

Not known: frequency cannot be determined from the available data

• skin rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RILUTEK

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What RILUTEK contains

• The active substance is riluzole.
• The excipients are:
  Core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, sodium croscarmellose.
  Coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

Description of the appearance of RILUTEK and pack contents
The tablets are film-coated, capsule-shaped, and white. Each tablet contains 50 mg of riluzole and is marked on one side with "RPR 202". RILUTEK is available in packs of 56 tablets for oral administration.

Marketing Authorization Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For further information about this product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: +49 (0)180 2 222010

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
From abroad: +33 1 57 63 23 23

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Ísland
Vistor hf.
Sími: +354 535 7000

Italia
Sanofi S.r.l.
Tel: 800 536389

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

Luxembourg/Luxemburg (Belgique/Belgien)
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

Portugal
Sanofi-Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

United Kingdom
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

This summary of product characteristics was last approved on {MM/YYYY}