Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rilutek

Document Subject

Generated Narrative: MedicinalProductDefinition mp68bcf84e560e25281fc234537e658487

identifier: http://ema.europa.eu/identifier/EU/1/96/010/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: RILUTEK 50 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-68bcf84e560e25281fc234537e658487

identifier: http://ema.europa.eu/identifier/EU/1/96/010/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rilutek

Attesters

What is in this leaflet

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

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 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 your doctor before taking RILUTEK:

• 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 If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.

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

Pregnancy, breast-feeding and fertility 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 lightheaded after taking this medicine.

RILUTEK contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 medicine, ask your doctor or pharmacist.

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 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).

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

• dizziness
• numbness or tingling of the mouth
• vomiting
• sleepiness
• increase in heartbeat
• diarrhoea
• headache
• abdominal pain
• pain

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

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

Not known: frequency cannot be estimated from the available data

• rash

Reporting of side effects If you get 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 to be taken orally.

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

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

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

Belgi /Belgique/ Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika Sanofi s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l.
Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l : 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l.
Tel: 800 536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last approved in {MM/YYYY}.