Riluzole Aurovitas 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Riluzol Aurovitas 50 mg Film-coated Tablets EFG

Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effect is not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

What Riluzol Aurovitas is

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

What Riluzol Aurovitas is 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, loss of muscle mass, 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. Riluzole inhibits the release of glutamate, which may help prevent damage to nerve cells.

For further information, consult your doctor regarding ALS and the reason why this medicine has been prescribed for you.

2. What you need to know before starting Riluzol Aurovitas

Do not take Riluzol Aurovitas

• if you are allergic to riluzole or to any of the other ingredients of this medicine (listed in section 6).
• if you have any liver disease or elevated 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), widespread itching, feeling unwell, nausea.
• if your kidneys are not functioning properly.
• if you have fever: this may be due to a reduced number of white blood cells, which could increase the risk of developing infections.

If any of the above conditions apply to you, or if you are unsure, inform your doctor so that they can advise you on what to do.

Children and adolescents

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

Other medicines and Riluzol Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 medicine.

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

Driving and using machines

You may drive or operate tools or machinery, unless you feel dizzy or confused after taking this medicine.

Riluzol Aurovitas contains sodium

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

3. How to take Riluzol Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet twice daily.

The tablets should be taken orally every 12 hours, at the same time each day (for example, in the morning and at night).

If you take more Riluzol Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Riluzol Aurovitas

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

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

If you stop taking Riluzol Aurovitas

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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.

Contact your doctor immediately

• if you have fever (raised temperature), because riluzole may cause a decrease in the number of white blood cells. Your doctor may ask you to have blood tests to monitor your white blood cell count, which are important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or whites of the eyes (jaundice), widespread itching, dizziness or nausea, as these 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 cough or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).

Very common adverse effects (may affect more than 1 in 10 people)

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

Common adverse 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.
• diarrhoea.
• pain.

Uncommon adverse 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).
• anaemia.
• inflammation of the pancreas (pancreatitis).

Frequency not known (cannot be estimated from available data)

• skin rash.

• data from studies indicate that Asian patients may be more susceptible to liver function test abnormalities than Caucasian patients.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Riluzole Aurovitas

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

Do not use this medicine after the expiry date stated on the outer packaging and on the blister. The expiry date refers to the last day of the month indicated.

Aluminium/aluminium blisters: This medicine does not require any special storage conditions.

Aluminium/PVC blisters: Keep the blister in the outer packaging to protect it from light. This medicine does not require any special temperature storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Riluzol Aurovitas

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

Tablet core: calcium hydrogen phosphate, pregelatinized maize starch (gluten-free), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and pack contents

Film-coated oval biconvex tablets, white or slightly white in colour, marked "RL 50".

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700 - 487 Amadora

Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Belgium: Riluzol AB 50 mg filmomhulde tabletten

Spain: Riluzol Aurovitas 50 mg comprimidos recubiertos con película EFG

France: Riluzole Arrow 50 mg, comprimé pelliculé

Italy: Riluzolo Aurobindo 50 mg compresse rivestite con film

Portugal: Riluzol Aurovitas

Date of the most recent review of this leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).