Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
topiramate 50 mg
Arrow Generics Limited
N03AX11
topiramate
hard capsule
Authorised
2014-06-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPIRAMATE CAPSULES, HARD (TOPIRAMATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do NOT pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Topiramate is and what it is used for 2. Before you take Topiramate Capsules 3. How to take Topiramate Capsules 4. Possible side effects 5. How to store Topiramate Capsules 6 Further information 1. WHAT TOPIRAMATE CAPSULES IS AND WHAT IT IS USED FOR Topiramate Capsules belongs to a group of medicines called “antiepileptic medicines.” It is used: • alone to treat seizures in adults and children over age 6 • with other medicines to treat seizures in adults and children over age 2 • to prevent migraine headaches in adults 2. BEFORE YOU TAKE TOPIRAMATE CAPSULES Do not take Topiramate Capsules: • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate Capsules (listed in section 6). • for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breastfeeding’ for further information). If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Capsules. TAKE SPECIAL CARE WITH TOPIRAMATE CAPSULES: Check with your doctor or pharmacist before taking Topiramate Capsules if you: Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topiramate 50mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50mg of topiramate. Each capsule also contains 138mg of sucrose. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard (capsule). White opaque body and white opaque cap. The body has ‘50’ printed in black and the cap has ‘>’ over ‘Ti’ printed in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures. Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION General It is recommended that therapy be initiated at a low dose followed by titration to an effective dose. Dose and titration rate should be guided by clinical response. Topiramate is available in film-coated tablet and a hard capsule formulations. It is recommended that film-coated tablets not be broken. The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly. Topiramate Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents Olvassa el a teljes dokumentumot