Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOPIRAMATE
JOHNSON & JOHNSON SDN BHD
TOPIRAMATE
60Tablet Tablets
CILAG AG
TOPAMAX ® TABLET Topiramate (25mg, 50mg, 100mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What TOPAMAX ® is used for 2. How TOPAMAX ® works 3. Before you use TOPAMAX ® 4. How to use TOPAMAX ® 5. While you are using it 6. Side effects 7. Storage and disposal of TOPAMAX ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT TOPAMAX ® IS USED FOR TOPAMAX ® 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 TOPAMAX ® for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. HOW TOPAMAX ® WORKS Although the exact way TOPAMAX ® 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 TOPAMAX ® - _When you must not use it _ • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of TOPAMAX ® (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 TOPAMAX ® . If you are not sure if the above applies to you, talk to your doctor or pharmacist before using TOPAMAX ® . _Pregnancy and breast-feeding _ Migraine prevention: TOPAMAX ® can harm an unborn baby. You must not use TOPAMAX ® if you are pregnant. You must not use TOPAMAX ® 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 contraceptio Aqra d-dokument sħiħ
1 PRODUCT NAME TOPAMAX ® DOSAGE FORMS AND STRENGTHS FILM-COATED TABLETS The tablets are debossed, engraved or embossed. 25 MG TABLET Round, white tablet imprinted with “TOP” on one side and “25” on the other. Each tablet contains 25 mg of topiramate. 50 MG TABLET Round, light yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “50” on the other. Each tablet contains 50 mg of topiramate. 100 MG TABLET Round, yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “100” on the other. Each tablet contains 100 mg of topiramate. For excipients, see _List of Excipients._ CLINICAL INFORMATION INDICATIONS EPILEPSY TOPAMAX is indicated as monotherapy in patients with newly diagnosed epilepsy or for conversion to monotherapy in patients with epilepsy. TOPAMAX is indicated as adjunctive therapy for adults and children aged 2 and above with partial onset seizures or generalized tonic-clonic seizures. TOPAMAX is also indicated in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. MIGRAINE TOPAMAX is indicated in adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied. DOSAGE AND ADMINISTRATION It is not necessary to monitor topiramate plasma concentrations to optimize therapy with TOPAMAX. On rare occasions, the addition of TOPAMAX to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with TOPAMAX may require adjustment of the dose of TOPAMAX. DOSAGE It is recommended that therapy be initiated at a low dose followed by titration to an effective dose. _EPILEPSY – ADJUNCTIVE THERAPY _ • ADULTS 2 Therapy should begin at 25 to 50 mg nightly for one week. Use of lower initial doses has been reported, but has not been studied systematically. Subsequently, at weekly or bi-weekly _ _ intervals, the dose should be Aqra d-dokument sħiħ