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RILUTEK 50 mg FILM-COATED TABLETS

RILUTEK 50 mg FILM-COATED TABLETS

Ask a doctor about a prescription for RILUTEK 50 mg FILM-COATED TABLETS

5.0(3)
Doctor

Anastasiia Hladkykh

Psychiatry15 years of experience

Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

Key areas of expertise:

  • Addiction treatment: alcohol and drug dependence, gambling addiction, compulsive behaviours, codependent relationships.
  • Support for families of addicted individuals, behavioural correction within the family system, guidance for maintaining remission.
  • Mental health: depression, bipolar disorder, obsessive-compulsive disorder (OCD), anxiety disorders, phobias, PTSD, generalised anxiety, emotional trauma, and the psychological impact of loss or emigration.
  • Psychoeducation: explaining complex mental health concepts in simple language, helping patients and their families understand diagnoses and treatment steps.
Therapeutic approach:
  • Client-centred, straightforward, and empathetic – focused on practical outcomes and emotional stabilisation.
  • Prescribes medications when needed, but always aims to minimise unnecessary pharmaceutical use.
  • Certified in multiple evidence-based methods: CBT, NLP (Master Practitioner), Ericksonian hypnosis, symbol drama, art therapy, and systemic therapy.
  • Each consultation results in a clear, structured plan – patients leave knowing exactly what to do next.
Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
  • More than 18 publications in international peer-reviewed journals, translated into several languages.
  • Volunteer work with Ukrainian refugees and military personnel at the University Clinic of Regensburg.
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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use 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:

  • dizziness
  • numbness or tingling of the mouth
  • vomiting
  • drowsiness
  • rapid heartbeat
  • diarrhea
  • headache
  • abdominal pain
  • pain

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.

België/Belgique/ Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

????????

Swixx Biopharma EOOD

???.: +359 (0)2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium

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

Ceská republika

Sanofi s.r.o.

Tel: +420 233 086 111

Magyarország

SANOFI-AVENTIS Zrt.

Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: +49 (0)180 52 52 010

Tel. from abroad: +49 69 305 21 131

Nederland

Sanofi B.V.

Tel: +31 20 245 4000

Eesti

Swixx Biopharma OÜ

Tel: +372 640 10 30

Norge

sanofi-aventis Norge AS

Tlf: +47 67 10 71 00

Ελλ?δα

Sanofi-Aventis Μονοπρ?σωπη AEBE

Τηλ: +30 210 900 16 00

Österreich

sanofi-aventis GmbH

Tel: +43 1 80 185 – 0

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

sanofi-aventis Sp. z o.o.

Tel.: +48 22 280 00 00

France

Sanofi Winthrop IndustrieTél : 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Hrvatska

Swixx Biopharma d.o.o.

Tel: +385 1 2078 500

Portugal

Sanofi - Produtos Farmacêuticos, Lda.

Tel: +351 21 35 89 400

România

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Slovenija

Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600

Italia

Sanofi S.r.l.

Tel: 800 536389

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κ?προς

C.A. Papaellinas Ltd.

Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

Swixx Biopharma SIA

Tel: +371 6 616 47 50

United Kingdom

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +44 (0) 800 035 2525

This leaflet was approved in (month/year)

Alternatives to RILUTEK 50 mg FILM-COATED TABLETS in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to RILUTEK 50 mg FILM-COATED TABLETS in Poland

Dosage form: Tablets, 50 mg
Active substance: riluzole
Importer: Sun Pharmaceutical Industries Europe B.V.
Prescription not required
Dosage form: Tablets, 50 mg
Active substance: riluzole
Prescription required

Alternative to RILUTEK 50 mg FILM-COATED TABLETS in Ukraine

Dosage form: tablets, 50 mg
Active substance: riluzole
Dosage form: solution, 50 mg/ml in 2 ml ampoule
Prescription required
Dosage form: solution, 50 mg/ml, 2 ml in ampoule
Prescription required
Dosage form: lyophilizate, 3 ampoules with lyophilizate and 3 ampoules with 2 ml solvent
Prescription required
Dosage form: capsules, 15 capsules in a blister
Prescription required
Dosage form: solution, 50 mg/ml, 2 ml in ampoule
Prescription required

Online doctors for RILUTEK 50 mg FILM-COATED TABLETS

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for RILUTEK 50 mg FILM-COATED TABLETS – subject to medical assessment and local rules.

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He offers compassionate, evidence-based support for individuals dealing with:

  • depression and anxiety disorders
  • bipolar affective disorder
  • schizophrenia and other psychotic conditions
  • psychosomatic symptoms and chronic stress
  • treatment planning and medication adjustment
Dr. Laafif combines scientific expertise with human empathy, helping patients restore emotional balance, improve daily functioning, and regain confidence in their recovery journey.
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Anastasiia Hladkykh

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Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

Key areas of expertise:

  • Addiction treatment: alcohol and drug dependence, gambling addiction, compulsive behaviours, codependent relationships.
  • Support for families of addicted individuals, behavioural correction within the family system, guidance for maintaining remission.
  • Mental health: depression, bipolar disorder, obsessive-compulsive disorder (OCD), anxiety disorders, phobias, PTSD, generalised anxiety, emotional trauma, and the psychological impact of loss or emigration.
  • Psychoeducation: explaining complex mental health concepts in simple language, helping patients and their families understand diagnoses and treatment steps.
Therapeutic approach:
  • Client-centred, straightforward, and empathetic – focused on practical outcomes and emotional stabilisation.
  • Prescribes medications when needed, but always aims to minimise unnecessary pharmaceutical use.
  • Certified in multiple evidence-based methods: CBT, NLP (Master Practitioner), Ericksonian hypnosis, symbol drama, art therapy, and systemic therapy.
  • Each consultation results in a clear, structured plan – patients leave knowing exactly what to do next.
Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
  • More than 18 publications in international peer-reviewed journals, translated into several languages.
  • Volunteer work with Ukrainian refugees and military personnel at the University Clinic of Regensburg.
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With a personalised, evidence-based approach, Dr. Nalkin helps patients restore physical function, reduce pain, and improve quality of life through targeted therapy and long-term support.

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  • Sleep disturbances – insomnia, daytime sleepiness, fragmented sleep.
  • Anxiety, depression, and stress-related conditions.

Dr. Agapova helps patients manage complex neurological symptoms like pain, numbness, weakness, poor sleep, and emotional distress. Her consultations focus on accurate diagnosis, clear explanation of findings, and tailored treatment plans.

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  • schizoaffective disorder;
  • schizophrenia;
  • personality disorders.
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  • Post-traumatic stress disorder (PTSD)
  • Psychosomatic symptoms and sleep disturbances
  • Health anxiety (hypochondria)
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