Riluzole Zentiva

Patient Information Leaflet: Information for the User

Riluzole Zentiva 50 mg film-coated tablets

riluzole
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Riluzole Zentiva is and what it is used for

What Riluzole Zentiva is
The active substance in Riluzole Zentiva is riluzole, which acts on the nervous system.
What Riluzole Zentiva is used for
Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neuron disease in which damage to nerve cells responsible for sending signals to muscles leads to muscle weakness, muscle atrophy, and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by excessive glutamate (a chemical messenger) in the brain and spinal cord. Riluzole Zentiva inhibits the release of glutamate, which may help prevent damage to nerve cells.
Please consult your doctor for further information on ALS and why this medicine has been prescribed to you.

2. What you need to know before taking Riluzole Zentiva

Do not take Riluzole Zentiva

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

Warnings and precautions
Talk to your doctor before taking Riluzole Zentiva

• if you have liver problems: yellowing of the skin or the white part of the eye (jaundice),
  itching all over the body, feeling unwell, or nausea
• if your kidneys are not working properly
• if you develop fever: this could be due to a decrease in white blood cells; such a decrease may increase the risk of infections

If any of the above conditions occur, or if you are unsure, consult your doctor,
who will decide what action to take.
Children and adolescents
If you are under 18 years of age. The use of Riluzole Zentiva is not recommended because there is no
available information in this population.
Other medicines and Riluzole Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy, breastfeeding and fertility
YOU MUST NOT take Riluzole Zentiva if you are pregnant or think you might be pregnant, or if you are breastfeeding.
If you think you may be pregnant or if you intend to breastfeed, consult your doctor before taking Riluzole Zentiva.
Driving and using machines
You may drive or operate any tools or machinery unless, after taking this medicine,
you experience dizziness or a sensation of light-headedness.

3. How to take Riluzole Zentiva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
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 evening).
If you take more Riluzole Zentiva than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
If you forget to take Riluzole Zentiva
If you forget to take a tablet, skip the missed dose and take the next tablet at your usual scheduled time.
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

IMPORTANT
Contact your doctor immediately

• if you develop fever (raised body temperature), because Riluzole Zentiva can cause a decrease in the number of white blood cells. Your doctor may ask you to have a blood test to check your white blood cell count, as these cells are important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or the white part of the eye (jaundice), itching all over the body, feeling unwell or becoming ill, as these may indicate liver disease (hepatitis). Your doctor may carry out regular blood tests while you are taking Riluzole Zentiva to ensure this does not occur.
• if you develop cough or breathing difficulties, as these may be signs of a lung disorder (called interstitial lung disease).

Other side effects

Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva are:

• fatigue
• malaise
• increased blood levels of certain liver enzymes (transaminases)

Common side effects (may affect more than 1 in 100 people but less than 1 in 10) of Riluzole Zentiva are:

• dizziness
• numbness or tingling of the mouth
• vomiting
• somnolence
• increased heart rate
• diarrhoea
• headache
• abdominal pain
• pain

Uncommon side effects (may affect more than 1 in 1,000 people but less than 1 in 100) of Riluzole Zentiva are:

• anaemia
• allergic reactions
• inflammation of the pancreas (pancreatitis)

Not known: frequency cannot be estimated based on available data

• rash

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Riluzole Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Riluzole Zentiva contains

• The active substance is riluzole.
• The other components are:
  Core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium croscarmellose.
  Coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

Description of the appearance of Riluzole Zentiva and contents of the pack
The tablets are film-coated, capsule-shaped, and white. Each tablet contains 50 mg of riluzole, with “RPR 202” engraved on one side.
Riluzole Zentiva is available in packs of 28, 56, 98, 112, or 168 tablets for oral use.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturers
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

България (Bulgaria)
Zentiva, k.s.
Тел: +359 244 17136
[email protected]

Česká republika (Czech Republic)
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Danmark (Denmark)
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Deutschland (Germany)
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Eesti (Estonia)
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Ελλάδα (Greece)
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

España (Spain)
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Hrvatska (Croatia)
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]

Ísland (Iceland)
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]

Italia (Italy)
Zentiva Italia S.r.l.
+39-02-38598801
[email protected]

Κύπρος (Cyprus)
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Latvija (Latvia)
Zentiva, k.s.
Tel: +371 67893939
[email protected]

Lietuva (Lithuania)
Zentiva, k.s.
Tel: +370 52152025
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Magyarország (Hungary)
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]

Nederland (Netherlands)
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Norge (Norway)
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]

Österreich (Austria)
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

Polska (Poland)
Zentiva Polska Sp. z o.o.
Tel: +48 22 375 92 00
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351 210 601 360
[email protected]

România (Romania)
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Slovenija (Slovenia)
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Slovenská republika (Slovakia)
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Sverige (Sweden)
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]

Annex IV
Scientific conclusions and grounds for the variation to the terms of the marketing authorizations

Scientific conclusions
Taking into account the evaluation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Reports (PSURs) for riluzole, the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
In view of the available data from spontaneous reports of skin rash, including in some cases a close temporal relationship, a positive de-challenge and/or re-challenge, the PRAC concluded that a causal relationship between riluzole and skin rash is at least a reasonable possibility, and that the product information for medicinal products containing riluzole should be updated accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.

Grounds for the variation to the terms of the marketing authorizations
Based on the scientific conclusions regarding riluzole, the CHMP considers that the benefit-risk balance of medicinal products containing riluzole remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends the variation of the terms of the marketing authorizations.