البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
Riluzole
Sanofi Winthrop Industrie
N07XX02
riluzole
Other nervous system drugs
Amyotrophic Lateral Sclerosis
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.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.
Revision: 32
Authorised
1996-06-10
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE USER RILUTEK 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 RILUTEK is and what it is used for 2. What you need to know before you take RILUTEK 3. How to take RILUTEK 4. Possible side effects 5. How to store RILUTEK 6. Contents of the pack and other information 1. WHAT RILUTEK IS AND WHAT IT IS USED FOR WHAT RILUTEK IS The active substance in RILUTEK is riluzole which acts on the nervous system. WHAT RILUTEK IS USED FOR RILUTEK 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. RILUTEK 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 RILUTEK DO NOT TAKE RILUTEK - 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 RILUTEK: اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. 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 _ 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. _ _ 3 _Paediatric population _ RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of ril اقرأ الوثيقة كاملة