RILUZOL SUN 50 mg FILM-COATED TABLETS

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.

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.

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/.