Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
Pharmathen S.A.
TOPIRAMATE
100 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-06-03
PIL DK/H/1188/001-004/DC 1/9 PACKAGE LEAFLET: I NFORMATION FOR THE USER TOPIRAMATE PHARMATHEN 25 MG FILM-COATED TABLETS TOPIRAMATE PHARMATHEN 50 MG FILM-COATED TABLETS TOPIRAMATE PHARMATHEN 100 MG FILM-COATED TABLETS TOPIRAMATE PHARMATHEN 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 or nurse. - 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 of effects talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Topiramate Pharmathen is and what it is used for 2. What you need to know before you take Topiramate Pharmathen 3. How to take Topiramate Pharmathen 4. Possible side effects 5. How to store Topiramate Pharmathen 6. Contents of the pack and other information 1. WHAT TOPIRAMATE PHARMATHEN IS AND WHAT IT IS USED FOR Topiramate Pharmathen 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE PHARMATHEN DO NOT TAKE TOPIRAMATE PHARMATHEN - if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). - for migraine prevention if Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topiramate Pharmathen 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of topiramate. Excipient: 0,05 mg sunset yellow (E110)/film-coated tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Topiramate Pharmathen 100 mg are available as orange, oblong, biconvex film-coated tablets. 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 generaliszed 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. It is recommended that film-coated tablets not be broken. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. 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 of phenytoin to achieve optimal clini Прочетете целия документ