Leaflet: information for the user

Riluzol Aurovitas 50 mg film-coated tablets

Read this 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. Do not give it to others even if they have similar symptoms to yours, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Riluzol Aurovitas

3.How to take Riluzol Aurovitas

4.Possible side effects

5.Storage of Riluzol Aurovitas

6.Contents of the pack and additional information

What is Riluzol Aurovitas

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

What is Riluzol Aurovitas used for

Riluzol 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 muscles and produces weakness, muscle wasting, and paralysis.

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

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

Do not take Riluzol Aurovitas

-if you are allergic to riluzol or any of the other ingredients in this medication (listed in section 6).

-if you have any liver disease or elevated levels of certain liver enzymes (transaminases) in your blood.

-if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor before starting to use Riluzol Aurovitas:

-if you haveliver problems: yellowing of the skin or white of the eyes (jaundice), generalized itching, feeling of dizziness, nausea.

-if yourkidneysdo not function correctly.

-if you havefever: it may be due to a lower number of white blood cells, which may increase the risk of infections.

If you are affected by any of the circumstances mentioned above or are unsure, inform your doctor so they can advise you on what to do.

Children and adolescents

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

Other medications and Riluzol Aurovitas

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

Pregnancy and breastfeeding

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

Do not take riluzol if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and operating machinery

You may 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”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 of day 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, consult your doctor or pharmacist immediately or call the Toxicological 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 compensate for the missed dose.

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

If you interrupt treatment with Riluzol Aurovitas

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

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

Important

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

-swelling of the face, tongue, or throat.

-difficulty swallowing.

-hives and difficulty breathing.

Consult your doctor immediately

-if you havefever(elevated temperature), because riluzol may cause a decrease in the number of white blood cells. Your doctor may instruct 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 the white 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 riluzol 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 side effects (may affect more than 1 in 10 people)

-fatigue.

-uncomfortable feeling.

-increase in levels of some liver enzymes (transaminases) in the blood. It 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.

-inflammation of the pancreas (pancreatitis).

Unknown frequency (cannot be estimated from available data)

• skin rash.

* The data from studies indicate that Asian patients may be more susceptible to presenting alterations in liver function tests than Caucasian patients.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton and on the blister pack.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 drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Riluzol Aurovitas

Core of the tablet: calcium hydrogen phosphate, gluten-free pregelatinized cornstarch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet: OPADRY AMB white 03F28689, which contains: hypromellose, macrogol 6000, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Film-coated tablets, oval and biconvex, white or off-white in color, and with the mark RL 50.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700 - 487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area with the following names:

Bélgica: Riluzol AB 50 mg filmomhulde tabletten

España: Riluzol Aurovitas 50 mg comprimidos recubiertos con película EFG

Francia: Riluzole Arrow 50 mg, comprimé pelliculé

Italia: Riluzolo Aurobindo 50 mg compresse rivestite con film

Portugal: Riluzol Aurovitas

Last review date of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).