Package leaflet: Information for the user

Riluzol PMCS, 50 mg, film-coated tablets
Riluzolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Riluzol PMCS is and what it is used for
What you need to know before taking Riluzol PMCS
How to take Riluzol PMCS
Possible side effects
How to store Riluzol PMCS
Contents of the pack and other information

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

The active substance in Riluzol PMCS is riluzole, which acts on the nervous system.
Riluzol PMCS is used in patients with amyotrophic lateral sclerosis (ALS - Sclerosis Lateralis Amyotrophica).
Amyotrophic lateral sclerosis is a form of motor neuron disease in which nerve cells responsible for transmitting signals to muscles are damaged, leading to muscle weakness, atrophy, and paralysis.
Nerve cell degeneration in motor neuron disease may be caused by excessive levels of glutamate (a neurotransmitter) in the brain and spinal cord. Riluzol PMCS inhibits the release of glutamate, which may help prevent damage to nerve cells.
Please consult your doctor for further explanations regarding amyotrophic lateral sclerosis and the reason why this medicine has been prescribed for you.

2. Important information before using Riluzol PMCS

When not to use Riluzol PMCS

if the patient is allergic to riluzole or any of the other ingredients of this medicine (listed in section 6),
if the patient has liver disease or increased activity of certain liver enzymes (aminotransferases) in the blood,
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Riluzol PMCS, discuss this with your doctor or pharmacist.

if the patient has any liver problems: yellowing of the skin or whites of the eyes (jaundice), itching, nausea, vomiting,
if the patient has kidney function disorders,
if the patient has fever: this may indicate too low a number of white blood cells, which may increase the risk of infection.

If any of the above information applies to the patient or the patient is unsure,
they should contact their doctor, who will decide on the appropriate course of action.
Children and adolescents
If the patient is under 18 years of age, the use of Riluzol PMCS is not recommended, as there is no information available for this patient group.
Riluzol PMCS and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist.
DO NOT take Riluzol PMCS if the patient is pregnant or suspects she is pregnant, or if she is breastfeeding.
Driving and operating machinery
The patient may drive or use tools or operate machinery if vertigo or dizziness does not occur after taking this medicine.
Riluzol PMCS contains sodium
Riluzol PMCS contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Riluzol PMCS

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The usual dose is one tablet twice daily. The tablets should be taken orally, every 12 hours,
at the same time each day (e.g. morning and evening).
Use of a higher than recommended dose of Riluzol PMCS
If a patient takes more tablets than prescribed, they should immediately contact
their doctor or the nearest hospital emergency department.
Missing a dose of Riluzol PMCS
If a patient forgets to take a tablet, they should skip that dose completely and take the next
tablet at the usual scheduled time. Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
IMPORTANT INFORMATION
You should contact your doctor immediately if:

you develop fever (raised body temperature), because Riluzol PMCS may reduce the number of white blood cells. Your doctor may order a blood test to check your white blood cell count, which is important in fighting infections;
you experience any of the following symptoms: yellowing of the skin or whites of the eyes (jaundice), itching, nausea, vomiting, as these may be signs of liver disease (hepatitis). During treatment with Riluzol PMCS, your doctor may order regular blood tests to ensure that liver disease is not occurring;
you develop cough or breathing difficulties, as these may be symptoms of a lung disease (called interstitial lung disease).

Other adverse reactions
Very common (may affect more than 1 in 10 people):

feeling of fatigue,
nausea,
increased activity of certain liver enzymes (aminotransferases) in blood.

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

dizziness,
drowsiness,
headache,
numbness or tingling of the lips,
increased heart rate,
abdominal pain,
vomiting,
diarrhoea,
pain.

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

anaemia,
allergic reactions,
pancreatitis.

Unknown (frequency cannot be estimated from the available data):

rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Riluzol PMCS

No special precautions for storage of the medicinal product are required.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Riluzol PMCS contains
The active substance is riluzole. Each coated tablet contains 50 mg of riluzole.
The other ingredients are:
Tablet core: calcium hydrogen phosphate anhydrous, granulated microcrystalline cellulose,
sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
Coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 400.

What Riluzol PMCS looks like and contents of the pack
Riluzol PMCS is available as almost white, round coated tablets with a diameter of 8 mm.
Riluzol PMCS is supplied in packs containing 56 or 100 coated tablets.

Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorised in the European Economic Area countries 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 pelicula
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