Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOPIRAMATE
UNIMED SDN BHD
TOPIRAMATE
60tablet Tablets; 3 X 10s Tablets
Aurobindo Pharma Limited (Unit III),
TORATE TABLET Topiramate (50mg, 100mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What TORATE is used for 2. How TORATE works 3. Before you use TORATE 4. How to use TORATE 5. While you are using it 6. Side effects 7. Storage and disposal of TORATE 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT TORATE IS USED FOR TORATE belongs to a group of medicines called ‘antiepileptic medicines’. It is used: • alone to treat seizures in adults • with other medicines to treat seizures in adults and children aged 2 years and above • to prevent migraine headaches in adults Your doctor may have prescribed TORATE for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. HOW TORATE WORKS Although the exact way TORATE works is unknown, it's believed to help ‘calm’ overexcitable nerve cells in the brain so they don't send out the signals that can cause migraines or seizures. BEFORE YOU USE TORATE - _When you must not use it _ • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of TORATE (listed in section ‘Product description’) • for migraine prevention: if you are pregnant or if you are a woman of childbearing potential unless you are using effective contraception (see section ‘Pregnancy and breast- feeding’ for further information). You should talk to your doctor about the best kind of contraception to use while you are taking TORATE. If you are not sure if the above applies to you, talk to your doctor or pharmacist before using TORATE. _Pregnancy and breast-feeding _ Migraine prevention: TORATE can harm an unborn baby. You must not use TORATE if you are pregnant. You must not use TORATE for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Talk to your doctor about the best kind of contraception and whether TORATE is suitable for you. Before the start of treatment w Preberite celoten dokument
TORATE 50 MG & 100 MG TABLETS TOPIRAMATE TABLETS 50 MG & 100 MG DESCRIPTION TORATE 50MG TABLETS Light yellow colored, circular, biconvex film-coated tablets debossed with ‘E’ on one side and ‘33’ on the other side. Each film-coated tablet contains topiramate 50mg. TORATE 100MG TABLETS Dark yellow colored, circular, biconvex beveled edged film-coated tablets debossed with 'E' on one side and '23' on the other side. Each film tablet contains Topiramate 100 mg. PHARMACODYNAMICS Topiramate is classified as a sulfamate-substituted monosaccharide. The precise mechanisms by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. PHARMACOKINETICS The pharmacokinetic profile of topiramate compared to other antiepileptic drugs shows along plasma half-life, linear pharmacokinetics, predominantly renal clearance, and absence of significant protein binding and lack of clinically relevant active metabolites. Topiramate is not a potent inducer of drug metabolizing enzymes, can be administered without regard to meals, and routine monitoring of plasma topiramate concentrations is not necessary. In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events. INDICATION 1. TORATE is indicated as monotherapy in patients with newly diagnosed epilepsy or for conversion to monotherapy in patients with epilepsy. 2. TORATE is indicated as adjunctive therapy for adults and children 2 years and above with partial onset seizures or generalized tonic-clonic seizures. 3. TORATE is also indicated in adults and children as adjunctive therapy for the tr Preberite celoten dokument