Riluzole Zentiva

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Riluzole Zentiva 50 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 50 mg of riluzole. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet  
The tablets are capsule-shaped, white and engraved with “RPR 202” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with 
amyotrophic lateral sclerosis (ALS). 
 
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS 
(see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical 
ventilation and tracheotomy-free. 
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, 
fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be 
effective in the late stages of ALS. 
 
Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva 
should not be used in patients with any other form of motor neurone disease. 
 
4.2 Posology and method of administration 
 
Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in 
the management of motor neurone diseases. 
 
Posology 
 
The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). 
No significant increased benefit can be expected from higher daily doses. 
 
Special populations 
 
Renal impairment 
Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at 
repeated doses have not been conducted in this population (see section 4.4). 
 
Elderly 
Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this 
population. 
 
Hepatic impairment 

 



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See sections 4.3, 4.4 and 5.2 
 
Paediatric population 
Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety 
and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents. 
 
Method of administration 
 
Oral use 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal. 
 
Patients who are pregnant or breast-feeding. 
 
4.4 Special warnings and precautions for use 
 
Hepatic impairment 
 
Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in 
patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper 
limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels. Baseline 
elevations of several liver function tests (especially elevated bilirubin) should preclude the use of 
riluzole (see section 4.8). 
 
Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and 
during therapy with riluzole. ALT should be measured every month during the first 3 months of 
treatment, every 3 months during the remainder of the first year, and periodically thereafter. ALT 
levels should be measured more frequently in patients who develop elevated ALT levels. 
 
Riluzole should be discontinued if the ALT levels increase to 5 times the ULN. There is no experience 
with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times 
ULN. Readministration of riluzole to patients in this situation cannot be recommended. 
 
Neutropenia 
 
Patients should be warned to report any febrile illness to their physicians. The report of a febrile illness 
should prompt physicians to check white blood cell counts and to discontinue riluzole in case of 
neutropenia (see section 4.8). 
 
Interstitial lung disease 
 
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them 
were severe (see section 4.8). If respiratory symptoms develop such as dry cough and/or dyspnoea, 
chest radiography should be performed, and in case of findings suggestive of interstitial lung disease 
(e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of 
the reported cases, symptoms resolved after medicinal product discontinuation and symptomatic 
treatment.  
 
Renal impairment 
 
Studies at repeated doses have not been conducted in patients with impaired renal function (see section 
4.2). 

 



4 

 
4.5 Interaction with other medicinal products and other forms of interaction 
 
There have been no clinical studies to evaluate the interactions of riluzole with other medicinal 
products. 
 
In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal 
isozyme involved in the initial oxidative metabolism of riluzole. Inhibitors of CYP 1A2 (e.g. caffeine, 
diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, 
amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while 
inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could 
increase the rate of riluzole elimination. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).  
Clinical experience with riluzole in pregnant women is lacking. 
 
Breast-feeding 
 
Riluzole Zentiva is contraindicated in breast-feeding women (see sections 4.3 and 5.3).  
It is not known whether riluzole is excreted in human milk. 
 
Fertility 
 
Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 
15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy. 
 
4.7 Effects on ability to drive and use machines 
 
Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or 
operate machinery if these symptoms occur. 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly 
reported adverse reactions were asthenia, nausea and abnormal liver function tests. 
 
Tabulated summary of adverse reactions 
 
Undesirable effects ranked under headings of frequency are listed below, using the following 
convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare 
(≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available 
data). 

 



5 

 
 Very common Common Uncommon Not known 
Blood and 
lymphatic 
system disorders 

  Anaemia Severe 
neutropenia (see 
section 4.4) 

Immune system 
disorders 

  Anaphylactoid 
reaction, 
angioedema 

 

Nervous system 
disorders 

 Headache, 
dizziness,  
oral paraesthesia, 
somnolence 

  

Cardiac 
disorders 
 

 Tachycardia   

Respiratory, 
thoracic and 
mediastinal 
disorders 
 

  Interstitial lung 
disease (see 
section 4.4) 

 

Gastrointestinal 
disorders 
 

Nausea Diarrhoea, 
abdominal pain,  
vomiting 

Pancreatitis  

Hepato-biliary 
disorders 

Abnormal liver 
function tests 

  Hepatitis 

General 
disorders and 
administration 
site conditions 

Asthenia Pain   

 
Description of selected adverse reactions 
 
Hepato-biliary disorders 
Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with 
riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months 
while treatment was continued. These increases could be associated with jaundice. In patients (n=20) 
from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued 
and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section 
4.4) 
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 
3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and 
methaemoglobinaemia have been observed in isolated cases. 
 
In case of overdose, treatment is symptomatic and supportive. 

 

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6 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02. 
 
Mechanism of action 
 
Although the pathogenesis of ALS is not completely elucidated, it is suggested that glutamate (the 
primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the 
disease. 
 
Riluzole is proposed to act by inhibiting glutamate processes. The mode of action is unclear. 
 
Clinical efficacy and safety 
 
In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and 
were followed-up for 12 to 21 months. Survival, as defined in the second paragraph of section 4.1, was 
significantly extended for patients who received riluzole as compared to patients who received 
placebo. The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, 
respectively. 
 
In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: 
riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months. In patients treated with 
riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo. The 
effect of riluzole 50 mg/day was not statistically significant compared to placebo and the effect of 
200 mg/day was essentially comparable to that of 100 mg/day. The median survival time approached 
16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively. 
 
In a parallel group study designed to assess the efficacy and safety of riluzole in patients at a late stage 
of the disease, survival time and motor function under riluzole did not differ significantly from that of 
placebo. In this study the majority of patients had a vital capacity less than 60%. 
 
In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in 
Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or 
placebo and were followed-up for 18 months. In this study, the efficacy was assessed on inability to 
walk alone, loss of upper limb function, tracheostomy, need for artificial ventilation, gastric tube 
feeding or death. Tracheostomy-free survival in patients treated with riluzole did not differ 
significantly from placebo. However, the power of this study to detect differences between treatment 
groups was low. Meta-analysis including this study and those described above showed a less striking 
effect on survival for riluzole as compared to placebo although the differences remained statistically 
significant. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral 
administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid. 
Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent. 
With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole 
accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days. 
 
Absorption 

 



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Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring 
within 60 to 90 minutes (Cmax=173 ± 72 (sd) ng/ml). About 90% of the dose is absorbed and the 
absolute bioavailability is 60 ± 18%. 
 
The rate and extent of absorption is reduced when riluzole is administered with high-fat meals 
(decrease in Cmax of 44%, decrease in AUC of 17%). 
 
Distribution 
 
Riluzole is extensively distributed throughout the body and has been shown to cross the blood brain 
barrier. The volume of distribution of riluzole is about 245 ± 69 L (3.4 L/kg). Riluzole is about 97% 
protein bound and it binds mainly to serum albumin and to lipoproteins. 
 
Biotransformation 
 
Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome 
P450 and subsequent glucuronidation. In vitro studies using human liver preparations demonstrated 
that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole. The 
metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged 
riluzole. 
 
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing 
N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole. This metabolite is rapidly 
glucuronoconjugated to O- and N-glucuronides. 
 
Elimination 
 
The elimination half-life ranges from 9 to 15 hours. Riluzole is eliminated mainly in the urine. 
The overall urinary excretion accounts for about 90% of the dose. Glucuronides accounted for more 
than 85% of the metabolites in the urine. Only 2% of a riluzole dose was recovered unchanged in the 
urine. 
 
Special populations 
 
Renal impairment 
There is no significant difference in pharmacokinetic parameters between patients with moderate or 
severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy 
volunteers after a single oral dose of 50 mg riluzole. 
 
Elderly 
The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment 
at 50 mg riluzole bid) are not affected in the older people (>70 years). 
 
Hepatic impairment 
The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild 
chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency. 
 
Race 
A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite 
N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese 
and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 
[90% CI 0.68-1.08] and AUC inf.  0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite. The 
clinical significance of these results is not known. 
 
5.3 Preclinical safety data 
 

 



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Riluzole did not show any carcinogenicity potential in either rats or mice. 
 
Standard tests for genotoxicity performed with riluzole were negative. Tests on the major active 
metabolite of riluzole gave positive results in two in vitro tests. Intensive testing in seven other 
standard in vitro or in vivo assays did not show any genotoxic potential of the metabolite. On the basis 
of these data, and taking into consideration the negative studies on the carcinogenesis of riluzole in the 
mouse and rat, the genotoxic effect of this metabolite is not considered to be of relevance in humans. 
 
Reductions in red blood cell parameters and/or alterations in liver parameters were noted 
inconsistently in subacute and chronic toxicity studies in rats and monkeys. In dogs, haemolytic 
anaemia was observed.  
In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of 
treated compared to control female rats. This isolated finding was not noted in any other study or 
species. 
 
All these findings were noted at doses which were 2-10 times higher than the human dose of 
100 mg/day. 
 
In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected. In 
rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least 
twice the systemic exposure of humans given clinical therapy. No malformations were seen in animal 
reproductive studies. 
 
In lactating rats, 14C-riluzole was detected in milk. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Core 
 
Dibasic calcium phosphate, anhydrous  
Micro crystalline cellulose  
Colloidal silica, anhydrous  
Magnesium stearate  
Croscarmellose sodium  
 
Coating 
  
Hypromellose 
Macrogol 6000  
Titanium dioxide (E171) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 

 



9 

6.5 Nature and contents of container 
 
Tablets are packaged in opaque pvc/aluminium blister cards. 
Each package contains 28, 56, 98, 112 or 168 tablets. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Zentiva k.s.  
U kabelovny 130  
102 37 Prague 10  
Czech Republic 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/768/001  
EU/1/12/768/002  
EU/1/12/768/003  
EU/1/12/768/004  
EU/1/12/768/005  
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 07 May 2012 
Date of latest renewal: {DD month YYYY} 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 

 



10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 

 



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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Sanofi Winthrop Industrie  
56, Route de Choisy au Bac 
60205 Compiègne 
France 
 
Winthrop Arzneimittel GmbH 
Brüningstraße 50 
K703 
D-65926 Frankfurt am Main 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
Not applicable 
 

 



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

 



14 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Riluzole Zentiva 50 mg film-coated tablets 
riluzole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 50 mg of riluzole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets 
28 film-coated tablets 
98 film-coated tablets 
112 film-coated tablets 
168 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

 



15 

APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva k.s.  
U kabelovny 130  
102 37 Prague 10  
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/768/001 – 56 film-coated tablets 
EU/1/12/768/002 – 28 film-coated tablets 
EU/1/12/768/003 – 98 film-coated tablets 
EU/1/12/768/004 – 112 film-coated tablets 
EU/1/12/768/005 – 168 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Riluzole Zentiva 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 

 



16 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
PVC/ALUMINIUM BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Riluzole Zentiva 50 mg film-coated tablets 
riluzole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva k.s.  
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 

 



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B. PACKAGE LEAFLET 

 



18 

 
Package leaflet: Information for the user 

 
Riluzole Zentiva 50 mg film-coated tablets 

riluzole 
 
 
Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
1. What Riluzole Zentiva is and what it is used for 
2. What you need to know before you take 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 neurone disease where attacks of the nerve cells responsible for sending 
instructions to the muscles lead to weakness, muscle waste and paralysis. 
 
The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a 
chemical messenger) in the brain and spinal cord. Riluzole Zentiva stops the release of glutamate and 
this may help in preventing the nerve cells being damaged. 
 
Please consult your doctor for more information about ALS and the reason why this medicine has been 
prescribed for you. 
 
 
2. What you need to know before you take Riluzole Zentiva 

 
Do not take Riluzole Zentiva 
- 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 increased blood levels of some enzymes of the liver 

(transaminases), 
- if you are pregnant or breast-feeding. 
 

 



19 

Warnings and precautions 
Talk to your doctor before taking Riluzole Zentiva: 
- if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), 

itching all over, feeling sick, being sick 
- if your kidneys are not working very well 
- if you have any fever: it may be due to a low number of white blood cells which can cause an 

increased risk of infection 
If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to 
do. 
 
Children and adolescents 
If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is 
no information available in this population. 
 
Other medicines and Riluzole Zentiva 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 
Pregnancy, breast-feeding and fertility 
You MUST NOT take Riluzole Zentiva if you are or think you may be pregnant, or if you are 
breast-feeding. 
 
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before 
taking Riluzole Zentiva. 
 
Driving and using machines 
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this 
medicine. 
 
 
3.  How to take Riluzole Zentiva 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet, twice a day.  
The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. 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 your tablet, leave out that dose completely and take the next tablet at the usual 
time. 
Do not take a double dose to make up for a forgotten tablet. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 

 



20 

4.  Possible side effects  
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
IMPORTANT 
Tell your doctor immediately 
- if you experience any fever (increase in temperature) because Riluzole Zentiva 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 your skin or the white of your 

eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease 
(hepatitis).Your doctor may do regular blood tests while you are taking Riluzole Zentiva to 
make sure that this does not occur. 

 
- if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called 

interstitial lung disease).  
 
Other side effects 
Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva are:  
- tiredness  
- feeling sick  
- increased blood levels of some enzymes of the liver (transaminases).  
 
Common side effects (may affect up to 1 in 10 people) of Riluzole Zentiva are:  
- dizziness - numbness or tingling of the mouth - vomiting 
- sleepiness - increase in heart beat - diarrhoea 
- headache - abdominal pain - pain 
 
Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: 
- anaemia  
- allergic reactions  
- inflammation of the pancreas (pancreatitis).  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix 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 which is stated on the carton and the blister after EXP. 
The expiry date refers to the last day of that month.  
 
This medicine does not require any special storage conditions. 
 
 

 

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21 

6. Contents of the pack and other information 
 
What Riluzole Zentiva contains 
 
- The active substance is riluzole. 
- The other ingredients are: 
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, 
magnesium stearate, croscarmellose sodium; 
Coating: hypromellose, macrogol 6000, titanium dioxide (E171). 
 
What Riluzole Zentiva looks like and content of the pack 
 
The tablets are film-coated, capsule-shaped and white. Each tablet contains 50 mg of riluzole and is 
engraved with “RPR 202” on one side. 
Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Zentiva k.s.  
U kabelovny 130  
102 37 Prague 10  
Czech Republic 
 
Manufacturers 
Sanofi Winthrop Industrie 
56, Route de Choisy au Bac 
60205 Compiègne 
France 
 
Winthrop Arzneimittel GmbH 
Brüningstraße 50 
K703 
D-65926 Frankfurt am Main 
Germany 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
Zentiva, k.s. 
Tél/Tel: +32 280 86 420 
PV-Belgium@zentiva.com 
 

Lietuva 
Zentiva, k.s. 
Tel: +370 52152025 
PV-Lithuania@zentiva.com 

България 
Zentiva, k.s. 
Тел: + 359 2 805 72 08 
PV-Bulgaria@zentiva.com 
 

Luxembourg/Luxemburg 
Zentiva, k.s. 
Tél/Tel: +352 208 82330 
PV-Luxembourg@zentiva.com 

Česká republika 
Zentiva, k.s. 
Tel: +420 267 241 111 
PV-Czech-Republic@zentiva.com 

Magyarország 
Zentiva, k.s. 
Tel.: +36 165 55 722 
PV-Hungary@zentiva.com 

Danmark 
Zentiva, k.s. 
Tlf: +45 787 68 400 

Malta 
Zentiva, k.s. 
Tel: +356 277 82 052 

 



22 

PV-Denmark@zentiva.com 
 

PV-Malta@zentiva.com 

Deutschland 
Zentiva Pharma GmbH  
Tel: +49 (0) 800 53 53 010 
PV-Germany@zentiva.com 
 

Nederland 
Zentiva, k.s. 
Tel: +31 202 253 638 
PV-Netherlands@zentiva.com 

Eesti 
Zentiva, k.s. 
Tel: +372 52 70308 
PV-Estonia@zentiva.com 
 

Norge 
Zentiva, k.s. 
Tlf: +47 219 66 203 
PV-Norway@zentiva.com 

Ελλάδα 
Zentiva, k.s. 
Τηλ: +30 211 198 7510 
PV-Greece@zentiva.com 
 

Österreich 
Zentiva, k.s. 
Tel: +43 720 778 877 
PV-Austria@zentiva.com 

España 
Zentiva, k.s. 
Tel: +34 931 815 250 
PV-Spain@zentiva.com 
 

Polska 
Zentiva Polska Sp. z o.o. 
Tel: + 48 22 375 92 00 
PV-Poland@zentiva.com 

France 
Zentiva France 
Tél: +33 (0) 800 089 219  
PV-France@zentiva.com 
 

Portugal 
Zentiva Portugal, Lda 
Tel: +351210601360 
PV-Portugal@zentiva.com 

Hrvatska 
Zentiva, k.s. 
Tel: +385 155 17 772 
PV-Croatia@zentiva.com 
 
Ireland 
Zentiva, k.s. 
Tel: +353 766 803 944 
PV-Ireland@zentiva.com 
 

România 
S.C. ZENTIVA S.A. 
Tel: +40 021 317 31 36 
PV-Romania@zentiva.com 
 
Slovenija 
Zentiva, k.s. 
Tel: +386 360 00 408 
PV-Slovenia@zentiva.com 

Ísland 
Zentiva, k.s. 
Sími: +354 539 0650 
PV-Iceland@zentiva.com 
 

Slovenská republika 
Zentiva, a.s. 
Tel: +421 2 3918 3010 
PV-Slovakia@zentiva.com 

Italia 
Zentiva Italia S.r.l. 
 +39-02-38598801 
PV-Italy@zentiva.com 

Suomi/Finland 
Zentiva, k.s. 
Puh/Tel: +358 942 598 648 
PV-Finland@zentiva.com 
 

Κύπρος 
Zentiva, k.s. 
Τηλ: +357 240 30 144 
PV-Cyprus@zentiva.com 
 

Sverige 
Zentiva, k.s. 
Tel: +46 840 838 822 
PV-Sweden@zentiva.com 

Latvija 
Zentiva, k.s. 
Tel: +371 67893939 
PV-Latvia@zentiva.com 

United Kingdom 
Zentiva Pharma UK Limited 
Tel: +44 (0) 845 372 7101 
PV-United-Kingdom@zentiva.com 

  

 



23 

 
 
 
This leaflet was last approved in {MM/YYYY}. 
 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET