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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 RILUZOL SUN 50 mg FILM-COATED TABLETS

Contents of the leaflet

  1. Introduction
  2. What is Riluzol SUN and what is it used for
  3. What you need to know before taking Riluzol SUN
  4. How to take Riluzol SUN
  5. Possible side effects
  6. Conservation of Riluzol SUN
  7. ADDITIONAL INFORMATION

Introduction

Package Leaflet: Information for the User

Riluzol SUN50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

  1. What is Riluzol SUN and what is it used for
  2. What you need to know before taking Riluzol SUN
  3. How to take Riluzol SUN
  4. Possible side effects

5 Conservation of Riluzol SUN

  1. Package contents and additional information

1. What is Riluzol SUN and what is it used for

What is Riluzol SUN

The active ingredient of Riluzol SUN is riluzole, which acts on the nervous system.

What is Riluzol SUN used for

Riluzol SUN 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 loss, and paralysis.

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

For more information, consult your doctor about ALS and the reason why you have been prescribed this medication.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Riluzol SUN

Do not take Riluzol SUN

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Riluzol SUN:

  • 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 function properly
  • if you have a fever: it may be due to a lower number of white blood cells, which can increase the risk of infection

If you are affected by any of the above circumstances or if you have any doubts, inform your doctor so that they can indicate what you should do.

Children and adolescents

If you are under 18 years of age, the use of Riluzol SUN is not recommended, as there is no available information on this population.

Taking Riluzol SUN with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medications.

Pregnancy and breastfeeding

DO NOT take Riluzol SUN if you are pregnant or think you may be pregnant, or if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and using machines

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

Riluzol SUN containssodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Riluzol SUN

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet twice a day.

Tablets should be taken orally, every 12 hours, at the same time each day (e.g., in the morning and at night).

If you take more Riluzol SUN than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Riluzol SUN

If you forget to take a tablet, skip this dose and take the next tablet at the usual time.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

IMPORTANT

Consult your doctor immediately

  • if you have a fever (increased temperature), as Riluzol SUN may cause a decrease in the number of white blood cells. Your doctor may indicate that you need to have blood tests to monitor the number of white blood cells, which are important in 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 they may be a sign of liver disease (hepatitis). Your doctor may perform periodic blood tests while you are taking Riluzol SUN to ensure that this does not occur.
  • if you experience cough or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).

Other side effects

The very common side effects(may affect more than 1 in 10 patients) of Riluzol SUN are:

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

The common side effects(may affect up to 1 in 10 people) of Riluzol SUN are:

  • vertigo
  • sleepiness
  • headache
  • numbness or tingling of the mouth
  • increased heart rate
  • abdominal pain
  • vomiting
  • diarrhea
  • pain

The uncommon side effects(may affect up to 1 in 100 people) of Riluzol SUN are:

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

The side effects with unknown frequencyare:

  • skin rash

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Riluzol SUN

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and blister. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Riluzol SUN 50 mg film-coated tablets

  • The active ingredient is riluzole. Each film-coated tablet contains 50 mg of riluzole.
  • The other ingredients are:

Core: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), povidone (K-30) (E1201), sodium croscarmellose (E468), anhydrous colloidal silica (E551), talc, magnesium stearate (E572)

Coating: Opadry white 03B68903 consisting of hypromellose 6 CP, titanium dioxide (E171), talc, macrogol 400.

Appearance of the product and package contents

The tablets are white to off-white, round, biconvex, with the inscription "538" on one side and smooth on the other side.

Riluzol SUN is available in a package of 56 or 98 tablets (4 or 7 blisters of 14 tablets each) for oral use.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Riluzol SUN 50 mg Filmtabletten

Italy: Riluzolo SUN 50 mg compresse rivestite con film

Spain: Riluzol SUN 50 mg comprimidos recubiertos con película EFG

United Kingdom (Northern Ireland): Riluzole 50 mg film-coated tablets.

This package leaflet was approved inJanuary 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

Online doctors for RILUZOL SUN 50 mg FILM-COATED TABLETS

Discuss questions about RILUZOL SUN 50 mg FILM-COATED TABLETS, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

Doctor

Svitlana Medvedkova

Neurology23 years of experience

Neurologist of the highest qualification category, Doctor of Medical Sciences and Professor, with 23 years of clinical experience and 19 years of teaching experience. Areas of expertise include general neurology, physical and rehabilitation medicine, and medical psychology.

Conditions and areas of care:

  • Acute and chronic vascular diseases of the brain and spinal cord, including stroke prevention

  • Demyelinating diseases, including multiple sclerosis

  • Neurodegenerative diseases, including Parkinson’s disease

  • Disorders of the peripheral nervous system, including spinal conditions, mono- and polyneuropathies, and cranial nerve disorders; autonomic nervous system disorders

  • Migraines, headaches and dizziness

  • Traumatic injuries of the central and peripheral nervous systems

  • Cognitive difficulties, including problems with memory and concentration

  • Emotional and neurotic disorders, including anxiety and depressive symptoms, panic attacks and increased anxiety; fatigue and chronic fatigue syndrome

  • Sleep disorders, including insomnia, difficulty falling asleep and disrupted sleep patterns

  • Rehabilitation following strokes, injuries and other neurological conditions, both in the acute and recovery stages

The doctor follows an evidence-based approach and has participated in international clinical research (GCP) for over 20 years. Their work includes developing personalised prevention, rehabilitation and cognitive programmes.

Consultation format: online consultations and remote follow-up care.

Book a video appointment
€136
Doctor
5.0(7)

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.
Book a video appointment
€156
Doctor

Elizaveta Marinicheva

Psychiatry5 years of experience

Elizaveta Marinicheva is a psychiatrist who has been practising since 2022. She received her medical degree from the University of Milan (Università degli Studi di Milano, UNIMI) and holds official authorisation to practise medicine in Italy (Abilitazione all'esercizio della professione medica). She is a member of the Milan Medical Association (Ordine dei Medici di Milano).

She is currently completing her specialist training in psychiatry at Sapienza University of Rome (Sapienza Università di Roma). She has also received additional training in psychoanalysis and has completed more than 500 hours of personal psychoanalytic therapy.

In her practice, Dr Marinicheva combines a modern medical approach to mental health with careful consideration of each patient's individual history and current condition. When pharmacotherapy is required, treatment decisions are based on the principles of evidence-based medicine and current international clinical guidelines, including NICE, APA, WFSBP and CANMAT.

Dr Marinicheva provides online psychiatry consultations for anxiety, low mood, emotional instability, sleep problems, chronic stress and other conditions affecting mental wellbeing and quality of life. During a consultation, she assesses the patient's symptoms and overall condition, discusses potential treatment approaches and, when clinically appropriate, recommends medication and an appropriate follow-up plan.

Book a video appointment
€166
Doctor
5.0(1)

Daria Portnova

Psychiatry31 years of experience

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations. In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life. Patients consult Dr Daria Portnova for the following concerns: 

  • existential crises and complex life situations;
  • loss, grief, and emotional exhaustion;
  • relationship difficulties, separation, and divorce;
  • psychological and psychiatric trauma, including complex PTSD (cPTSD);
  • anxiety disorders: generalised anxiety disorder and panic disorder;
  • social anxiety and social phobia;
  • obsessive-compulsive disorder (OCD);
  • sleep disorders;
  • depressive disorders;
  • bipolar affective disorder;
  • schizoaffective disorder;
  • schizophrenia;
  • personality disorders.

Dr Portnova combines psychiatric assessment with a psychotherapeutic approach. She works with evidence-based methods, including cognitive behavioural therapy (CBT) and third-wave approaches such as ACT, FACT, and CFT. Consultations are focused on clear clinical understanding, practical recommendations, and ongoing support over time.

Book a video appointment
€116
Doctor
5.0(24)

Taisiia Proida

Psychiatry7 years of experience
Licence no. 70352

Taisiia Proida is a general practitioner with a specialization in mental health and a cognitive behavioral therapist (CBT), a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care. She specialises in consultations and ongoing support for a wide range of mental health concerns, including: 

  • Mood disorders: depression, bipolar disorder, postpartum depression.
  • Anxiety disorders: generalised anxiety, OCD, panic attacks, phobias.
  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders. She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

Book a video appointment
€170

Frequently Asked Questions

RILUZOL SUN 50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in RILUZOL SUN 50 mg FILM-COATED TABLETS is riluzole. This information helps identify medicines with the same composition but different brand names.

RILUZOL SUN 50 mg FILM-COATED TABLETS is manufactured by Sun Pharmaceutical Industries (Europe) B.V.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Psychiatrists, Neurologists, General medicine doctors, Pain medicine doctors, Anaesthesiologists may assess whether RILUZOL SUN 50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, RILUZOL SUN 50 mg FILM-COATED TABLETS is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (riluzole) include EMYLIF 50 mg ORALLY DISINTEGRATING TABLETS, RILUTEK 50 mg FILM-COATED TABLETS, RILUZOL AUROVITAS 50 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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