Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM VALPROATE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
SODIUM VALPROATE
100Tablet Tablets
SANOFI-AVENTIS, S.A
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ EPILIM 200 ENTERIC COATED TABLET Sodium Valproate 200mg WARNING Epilim, Sodium Valproate can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use at least one effective method of birth control (contraception) without interruption during your entire treatment with Epilim. Your doctor should discuss with you the most appropriate method of contraception for you. Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant. You must not stop taking Epilim unless your doctor tells you to as your condition may become worse. WHAT IS IN THIS LEAFLET 1. What Epilim is used for 2. How Epilim works 3. Before you use Epilim 4. How to use Epilim 5. While you are using it 6. Side effects 7. Storage and Disposal of Epilim 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EPILIM IS USED FOR Epilim is used to treat few types of epilepsy (fits) in adults and children. Epilim may also be used to control bipolar disorder, a mental condition with mania symptoms (an elevation of mood). HOW EPILIM WORKS Epilim Enteric-coated (EC) have a protective coating that allows it to reach the intestines (gut) without being dissolved in the stomach first. This helps stop it from causing a stomach upset. Epilim contains a medicine called sodium valproate. This belongs to a group of medicines called anti- convulsants or anti-epileptic agents. It works by helping to calm the brain down. BEFORE YOU USE EPILIM - _When you must not use it_ Bipolar disorder • For bipolar disorder, you must not use Epilim if you are pregnant. • For bipolar disorder, if you are a woman able to have a baby, you must not take Epilim, unless you use at least one effective method of birth control (contraception) during your entire treatment with Epilim. You must not stop taking Epilim or interrupt your contraception, until you have discussed this with your doctor. Y Preberite celoten dokument
1 DRAFT PACKAGE INSERT NAME OF THE MEDICINAL PRODUCT EPILIM 200 ENTERIC COATED QUALITATIVE AND QUANTITATIVE COMPOSITION Epilim 200 Enteric Coated Tablets contain 200mg of Sodium Valproate PHARMACEUTICAL FORM Enteric coated tablets INDICATIONS Treatment of generalized or partial epilepsy, particularly with the following patterns of seizures: - Absence - Myoclonic - Tonic-clonic - Atonic - Mixed As well as, for partial epilepsy: - Simple or complex seizures - Secondary generalized seizures - Specific syndromes (West, Lennox-Gastaut) Treatment and prevention of mania associated with bipolar disorder. DOSAGE AND METHOD OF ADMINISTRATION Epilim 200 Enteric Coated Tablets are for oral administration. Daily dosage requirements vary according to age and body weight. Epilim tablets may be given twice daily. Tablets should be swallowed whole and not crushed or chewed. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other Epilim conventional or prolonged release formulations on an equivalent daily dosage basis. _DOSAGE _ Usual requirements are as follows: _TREATMENT OF EPILEPSY _ Adults Dosage should start at 600mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day, ie 20- 30mg/kg/day body weight. Where adequate control is not achieved within this range the dose may be further increased to 2500mg per day. Children over 20kg Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20-30mg/kg body weight per day. Where adequate control is not achieved within this range the dose may be increased to 35mg/kg body weight per day. Children under 20kg An alternative formulation of Epilim should be used in this group of patients, due to the tablet size and need for dose titration. Epilim Syrup is an alternative. 20mg/kg of body weight per day; in severe cases this may be increased but only in patients i Preberite celoten dokument