Riluzol Pmcs

Package Leaflet: Information for the User

Riluzol PMCS, 50 mg, Film-Coated Tablets

Riluzolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Riluzol PMCS and what is it 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 - Amyotrophic Lateral Sclerosis).
Amyotrophic lateral sclerosis is a form of motor neuron disease in which the attack on motor neurons responsible for transmitting information to muscles leads to weakness, muscle atrophy, and paralysis.
The destruction of motor neurons in motor neuron disease may be caused by an excessive amount of glutamate (a neurotransmitter) in the brain and spinal cord. Riluzol PMCS inhibits the release of glutamate, which may help prevent damage to motor neurons.
You should consult your doctor for more information about amyotrophic lateral sclerosis and the reason for prescribing the medicine to you.

2. Important information before taking Riluzol PMCS

When not to take Riluzol PMCS

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

Warnings and precautions

Before taking Riluzol PMCS, discuss it with your doctor or pharmacist.

• -if you have any liver problems: yellowing of the skin or whites of the eyes (jaundice), itching, nausea, vomiting,

if you have kidney function disorders,

• if you have a fever: this may indicate a low white blood cell count, which can increase the risk of infection.

If any of the above information applies to you or you are not sure, you should contact your doctor, who will decide what to do.

Children and adolescents

If you are under 18 years of age, taking Riluzol PMCS is not recommended, as there is no information available for this patient group.

Riluzol PMCS and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice.
DO NOT take Riluzol PMCS if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

You can drive or operate machinery if you do not feel dizzy or lightheaded after taking this medicine.

Riluzol PMCS contains sodium

Riluzol PMCS contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Riluzol PMCS

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is one tablet twice a day. Take the tablets orally, every 12 hours, at the same time each day (e.g., morning and evening).

Taking a higher dose of Riluzol PMCS than recommended

If you take more tablets than recommended, contact your doctor or the nearest emergency department immediately.

Missing a dose of Riluzol PMCS

If you forget to take a tablet, skip it completely and take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Riluzol PMCS can cause side effects, although not everybody gets them.

IMPORTANT INFORMATION

Seek medical attention immediately:

• if you have a fever (increased body temperature), as Riluzol PMCS may cause a decrease in white blood cell count. Your doctor may order a blood test to check your white blood cell count, which is important for fighting infections,
• if 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). While taking Riluzol PMCS, your doctor may order regular blood tests to ensure you do not have liver disease,
• if you have a cough or difficulty breathing, as these may be symptoms of lung disease (interstitial lung disease).

Other side effects

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

• feeling tired,
• nausea,
• increased activity of certain liver enzymes (aminotransferases) in the blood.

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

• dizziness,
• drowsiness,
• headache,
• numbness or tingling of the mouth,
• rapid heartbeat,
• abdominal pain,
• vomiting,
• diarrhea,
• pain.

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

• anemia,
• allergic reactions,
• pancreatitis.

Rare(cannot be estimated from the available data):

• rash.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Riluzol PMCS

There are no special precautions for storage of the medicinal product.
Keep the medicine 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Riluzol PMCS contains

The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
The other ingredients are:
Tablet core: calcium hydrogen phosphate anhydrous, microcrystalline cellulose granules, sodium croscarmellose, colloidal silica anhydrous, 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, film-coated tablets with a diameter of 8 mm.
Riluzol PMCS is supplied in packs containing 56 or 100 film-coated tablets.

Marketing authorization holder and manufacturer

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

This medicinal product 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 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

Date of last revision of the package leaflet: