RILUZOL AUROVITAS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Riluzol Aurovitas 50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, because 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Riluzol Aurovitas and what is it used for
2. What you need to know before taking Riluzol Aurovitas
3. How to take Riluzol Aurovitas
4. Possible side effects
5. Storage of Riluzol Aurovitas
6. Package Contents and Additional Information

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

What is Riluzol Aurovitas

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

What is Riluzol Aurovitas used for

Riluzole 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. Riluzole 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 Aurovitas

Do not take Riluzol Aurovitas

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

Warnings and Precautions

Consult your doctor before starting to use Riluzol Aurovitas:

• 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 are unsure, inform your doctor so that they can tell you what to do.

Children and Adolescents

If you are under 18 years of age. Riluzole is not recommended for use in children, as there is no available information in this population.

Other Medications and Riluzol Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Pregnancy and Breastfeeding

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

DO NOT take riluzole if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and Using Machines

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

Riluzol Aurovitas contains sodium

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

3. How to take Riluzol Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet twice a day.

The tablets should be taken orally, every 12 hours, at the same time each day (e.g., morning and evening).

If you take more Riluzol Aurovitas than you should

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

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

If you forget to take Riluzol Aurovitas

Do not take a double dose to make up for the missed dose.

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

If you interrupt treatment with Riluzol Aurovitas

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

You must stop taking riluzole and see your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or pharynx.
• difficulty swallowing.
• hives and difficulty breathing.

Consult your doctor immediately

• if you have a fever (increased temperature), because riluzole can cause a decrease in the number of white blood cells. Your doctor may tell you 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 signs of liver disease (hepatitis). Your doctor may perform periodic blood tests while you are taking riluzole to ensure this does not occur.
• if you experience coughing or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).

Very Common Side Effects (may affect more than 1 in 10 people)

• fatigue.
• discomfort.
• increased levels of certain liver enzymes (transaminases) in the blood. This may be associated with jaundice* (see section 2).

Common Side Effects (may affect up to 1 in 10 people)

• dizziness.
• drowsiness.
• headache.
• numbness or tingling sensation in the mouth.
• increased heart rate.
• abdominal pain.
• vomiting.
• diarrhea.
• pain.

Uncommon Side Effects (may affect up to 1 in 100 people)

• allergic reactions, swelling of the face, lips, tongue, or throat associated with difficulty breathing and/or swallowing (angioedema).
• anemia.
• pancreatitis (inflammation of the pancreas).

Frequency Not Known (cannot be estimated from available data)

• skin rash.

• study data indicate that Asian patients may be more susceptible to alterations in liver function tests than Caucasian patients.

Reporting Side Effects:

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

5. Storage of Riluzol Aurovitas

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

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.

Blister packs (aluminum/aluminum). This medication does not require special storage conditions.

Blister packs (aluminum/PVC): Keep the blister pack in the outer packaging to protect it from light. This medication does not require special temperature storage conditions.

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 you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Riluzol Aurovitas

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

Tablet core:calcium hydrogen phosphate, pregelatinized corn starch without gluten, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Tablet coating:OPADRY AMB white 03F28689, which contains: hypromellose, macrogol 6000, titanium dioxide (E171).

Appearance of the Product and Package Contents

Film-coated tablets, oval and biconvex, white or almost white, and marked with RL 50.

Blister packs containing 28, 30, 56, and 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700 - 487 Amadora

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Riluzol AB 50 mg film-coated tablets

Spain: Riluzol Aurovitas 50 mg film-coated tablets EFG

France: Riluzole Arrow 50 mg, film-coated tablet

Italy: Riluzolo Aurobindo 50 mg film-coated tablets

Portugal: Riluzol Aurovitas

Date of the Last Revision of this Package Leaflet: February 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/).