RILUTEK Film-coated tablet (2021)
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Περιεχόμενα
Name of the medicinal product
RILUTEK 50 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 50 mg of riluzole. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. The tablets are capsule-shaped, white and engraved with RPR 202 on one side.
Therapeutic indications
RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that RILUTEK extends survival for patients ...
Posology and method of administration
Treatment with RILUTEK 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 ...
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 ...
Special warnings and precautions for use
Liver 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 ...
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. <em>In vitro</em> studies using human liver microsomal preparations suggest that CYP 1A2 is the ...
Fertility, pregnancy and lactation
Pregnancy RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3). Clinical experience with riluzole in pregnant women is lacking Breast-feeding RILUTEK is contraindicated in breast-feeding ...
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 ...
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. ...
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. ...
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 ...
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 ...
Preclinical safety data
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 ...
List of excipients
<u>Core:</u> Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium <u>Coating:</u> Hypromellose Macrogol 6000 Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Tablets are packaged in opaque pvc/aluminium blister cards. Each package contains 56 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Sanofi Mature IP, 54 rue La Boétie, 75008, Paris, France
Marketing authorization number(s)
EU/1/96/010/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 June 1996 Date of last renewal: 10 June 2006
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