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- RILUTEK TABLET 50 MG [SIN09426P]
RILUTEK TABLET 50 MG [SIN09426P]
Active ingredients: RILUTEK TABLET 50 MG
Last updated 26 October 2025
Product Info
RILUTEK TABLET 50 MG
[SIN09426P]
Product information
Active Ingredient and Strength | RILUZOLE - 50 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | OPELLA HEALTHCARE INTERNATIONAL SAS - FRANCE |
Registration Number | SIN09426P |
Licence Holder | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N07XX02 |
INDICATIONS AND USAGE
RILUTEK is indicated for the treatment of patients with Amyotropic Lateral Sclerosis (ALS).
Riluzole extends survival and/or time to tracheostomy.
DOSAGE AND ADMINISTRATION
The recommended dose for RILUTEK is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased.
RILUTEK tablets should at least be taken an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.
Special Populations
Patients with Impaired or Renal or Hepatic Function: Studies have not yet been completed in these populations (see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
CONTRAINDICATIONS
RILUTEK is contraindicated in patients who have history of severe hypersensitivity reactions to riluzole or any of the tablet components.