Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM VALPROATE; VALPROIC ACID
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
SODIUM VALPROATE; VALPROIC ACID
30Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_ _ 1 _ _ _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ EPILIM CHRONO 500MG Sodium Valproate (500mg) _ _ 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 Chrono (controlled release tablet) is slowly released from the tablets over a period of time. 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 Chrono if you are pregnant. -For bipolar disorder, if you are a woman able to have a baby, you must not take Epilim Chrono, unless you use effective method of birth control (contraception) during your entire treatment with Epilim Chrono. Do not stop taking Epilim Chrono or your contraception, until you have discussed this with your doctor. Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility – Important advice for women”). _Epilepsy _ -For epilepsy, you must not use Epilim Chrono if you are pregnant, unless nothing else works for you. -For epilepsy, if you are a woman able to have a baby, you must not take Epilim Chrono unless you use effective method of birth control (contraception) during your entire treatment with Epilim Chrono. Do not stop taking Epilim Chrono or your contraception, until you have discussed this with your doctor. Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility – Important Read the complete document
1 NAME OF THE MEDICINAL PRODUCT Epilim Chrono 500 Controlled Release QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituents Each tablet contains 333mg Sodium Valproate and 145mg Valproic Acid equivalent to 500mg sodium valproate. Excipients with known effect: Sodium 46.08 mg (see Special Warnings and Precautions for Use). PHARMACEUTICAL FORM Prolonged Release Tablet. PRODUCT DESCRIPTION Oblong, practically white, scored film-coated tablets CLINICAL PARTICULARS THERAPEUTIC 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. POSOLOGY AND METHOD OF ADMINISTRATION Epilim Chrono Controlled Release Tablets are for oral administration. Epilim Chrono is a prolonged release formulation of Epilim which reduces peak concentration and ensures more even plasma concentrations throughout the day. Epilim Chrono 500 may be given once or twice daily. The tablets should be swallowed whole and not crushed or chewed. Daily dosage requirements vary according to age and body weight. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other conventional or prolonged release formulations on an equivalent daily dosage basis. _Dosage _ Usual requirements are as follows: 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 500mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20-30mg/kg body weight Read the complete document