Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
Rowex Ltd
N03AX11
TOPIRAMATE
25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2006-11-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Topit 25 mg film-coated tablets Topit 50 mg film-coated tablets Topit 100 mg film-coated tablets Topit 200 mg film-coated tablets Topiramate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What Topit is and what it is used for 2. What you need to know before you take Topit 3. How to take Topit 4. Possible side effects 5. How to store Topit 6. Contents of the pack and other information 1. WHAT TOPIT IS AND WHAT IT IS USED FOR Topit 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 aged 2 years and above • to prevent migraine headaches in adults 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIT DO NOT TAKE TOPIT • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topit 25 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of topiramate. Excipient with known effect: 17.8 mg lactose /film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Topit 25 mg film-coated tablet: White, round shaped, film-coated tablet, plain on both sides. 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 tablets and a hard capsule formulation. 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. It is not necessary to monitor topiramate plasma concentrations to optimize therapy with topiramate. On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose o Read the complete document