Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
RILUZOLE
SANOFI ISRAEL LTD
N07XX02
FILM COATED TABLETS
RILUZOLE 50 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
RILUZOLE
RILUZOLE
Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
2022-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only RILUTEK 50 MG FILM COATED TABLETS Active ingredient: Riluzole 50 mg Inactive and allergenic ingredients in the preparation: see section 6 “Further information” and section 2 “Important information regarding some of the ingredients of the medicine”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet; you may need to read it again. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The preparation is intended for the treatment of adults, from the age of 18 years. 1. WHAT IS THE MEDICINE INTENDED FOR? Treatment of ALS (amyotrophic lateral sclerosis) – a motor neuron disease. ALS is a type of neuronal disease that impairs transfer of information from the nerves to the muscles, which leads to weakness, muscle impairment and paralysis. THERAPEUTIC GROUP: The substance acts on the central nervous system. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are SENSITIVE (ALLERGIC) to the active ingredient or any of the additional ingredients contained in the medicine (see section 6 “Further Information”). You are suffering from a LIVER DISEASE or from an increase in blood level of enzymes associated with liver function (transaminases). You are PREGNANT or BREASTFEEDING. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Do not use the medicine without consulting a doctor before commencing treatment: ∙ If you are suffering from lIVER PROBLEMS: yellowing of the skin or the white part of the eyes (jaundice), itching all over the body, feeling sick or being sick. ∙ If your KIDNEYS are not functioning well. ∙ If you have any FEVER: it can be due to low white blood cell count, which Lugege kogu dokumenti
Rilutek-SPC-15.0 1 1. NAME OF THE MEDICINAL PRODUCT RILUTEK 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 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 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 RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. RILUTEK has not been shown to be effective in the late stages of ALS. Safety and efficacy of RILUTEK has only been studied in ALS. Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease. 4.2 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 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses. Rilutek tablets should be taken at least an hour before, or two hours after a meal to avoid a food related decrease in biovailability. Special populations _Impaired renal function _ RILUTEK 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). _Older people _ 2 Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population. _Impaired hepatic function_ See sections 4.3, 4.4 and 5.2. _ _ _Paediatric population _ RILUTEK i Lugege kogu dokumenti