RILUZOL PMCS 50 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Riluzol PMCS 50 mg film-coated tablets EFG

(riluzol)

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

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

Contents of the leaflet:

1. What is Riluzol PMCS 50 mg film-coated tablets EFG and what is it used for
2. What you need to know before taking Riluzol PMCS 50 mg film-coated tablets EFG
3. How to take Riluzol PMCS 50 mg film-coated tablets EFG
4. Possible side effects
5. Storage of Riluzol PMCS 50 mg film-coated tablets EFG
6. Package contents and additional information

1. What is Riluzol PMCS 50 mg film-coated tablets EFG and what is it used for

The active substance of Riluzol PMCS 50 mg film-coated tablets EFG is riluzole, which acts on the nervous system.

Riluzol PMCS 50 mg film-coated tablets EFG are used in patients with amyotrophic lateral sclerosis (ALS).

ALS is a form of motor neuron disease in which the damage to the nerve cells responsible for sending instructions to the muscles leads to weakness, muscle loss, and paralysis.

The destruction of nerve cells in motor neuron disease may be due to the presence of too much glutamate (a chemical messenger) in the brain and spinal cord. Riluzol PMCS 50 mg film-coated tablets EFG stop the release of glutamate, which may help prevent damage to nerve cells.

Consult your doctor for more information about ALS and why this medicine has been prescribed for you.

2. What you need to know before taking Riluzol PMCS 50 mg film-coated tablets EFG

Do not take Riluzol PMCS 50 mg film-coated tablets EFG

• if you are allergic to riluzole or any of the other ingredients of this medicine (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 or pharmacist before taking Riluzol PMCS 50 mg film-coated tablets EFG:

• if you have any type of liver problem: yellowing of the skin or whites of the eyes (jaundice), itching all over the body, nausea, vomiting.

• if your kidneys do not work well.

• if you notice any sign of fever: it may be due to a reduced number of white blood cells, which may increase the risk of infection.

If you are in any of the above situations or have doubts, inform your doctor, who will decide what to do.

Children and adolescents

If you are under 18 years old. The use of Riluzol PMCS 50mg film-coated tablets EFG is not recommended in children due to the lack of available information in this population.

Other medicines and Riluzol PMCS 50 mg film-coated tablets EFG

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and breastfeeding

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

DO NOT take Riluzol PMCS 50 mg film-coated tablets EFG if you are or think you may be pregnant or if you are breastfeeding.

Driving and using machines

You can drive or use any type of machine or tool, unless after taking this medicine you feel dizzy or faint.

Riluzol PMCS contains sodium

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

3. How to take Riluzol PMCS 50 mg film-coated tablets EFG

Follow the exact instructions for taking this medicine as indicated by your doctor. If in doubt, 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., in the morning and at night).

If you take more Riluzol PMCS 50 mg film-coated tablets EFG than you should

If you take too many tablets, go to your doctor or the nearest hospital emergency department 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, indicating the medicine and the amount.

If you forget to take Riluzol PMCS 50 mg film-coated tablets EFG

If you forget to take a tablet, skip that dose completely and take the next tablet at the usual time. Do not take a double dose to make up for the missed doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

IMPORTANT

Tell your doctor immediately

• if you notice any sign of fever (increased temperature), as Riluzol PMCS 50 mg film-coated tablets EFG may cause a decrease in the number of white blood cells. Your doctor may want to take a blood sample to check 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 Riluzol PMCS 50 mg film-coated tablets EFG to ensure this does not happen.

• if you experience cough or difficulty breathing, as they may be signs of lung disease (called interstitial lung disease).

Other side effects

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

• fatigue,
• dizziness,
• high blood levels of certain liver enzymes (transaminases).

Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

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

Frequency not known(cannot be estimated from available data):

• skin rash.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this 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 medicine.

5. Storage of Riluzol PMCS 50 mg film-coated tablets EFG

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Riluzol PMCS 50 mg film-coated tablets EFG

The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.

The other ingredients are:

Core of the tablet: anhydrous calcium hydrogen phosphate, granulated microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol 400.

Appearance of the product and package contents

Riluzol PMCS 50 mg film-coated tablets EFG are round, biconvex, almost white film-coated tablets, 8 mm in diameter.

Riluzol PMCS 50 mg film-coated tablets EFG are available in packs of 10, 30, 50, 56, 60, 90, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s., Telcská 377/1, Michle, Praha 4, 140 00, Czech Republic

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

Austria Riluzol PMCS 50 mg Filmtabletten

Czech Republic Riluzol PMCS

Denmark Riluzol PMCS 50 mg filmovertrukne tabletter

Spain Riluzol PMCS 50 mg comprimido recubierto con película

France Riluzole PMCS 50 mg, comprimé pelliculé

Poland Riluzol PMCS

Romania Riluzol PMCS 50 mg comprimate filmate

Sweden Riluzol PMCS 50 mg filmdragerade tabletter

Slovakia Riluzol PMCS 50 mg filmom obalené tablety

Date of the last revision of this leaflet:

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