Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Topiramate
Arrow Generics Ltd
N03AX11
Topiramate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100
TOPIRAMATE ACCORD HEALTHCARE 25MG, 50MG, 100MG AND 200MG FILM-COATED TABLETS (Topiramate) _Continued on next page_ 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. • The full name of this medicine is Topiramate Accord Healthcare 25mg, 50mg, 100mg and 200mg Film-coated Tablets but within the leaflet it will be referred to as Topiramate tablets. WHAT IS IN THIS LEAFLET: 1 WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE TABLETS 3 HOW TO TAKE TOPIRAMATE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE TOPIRAMATE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR Topiramate 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 TOPIRAMATE TABLETS DO NOT TAKE TOPIRAMATE TABLETS • if you are ALLERGIC to topiramate or any of the other ingredients of this medicine (listed in section 6). • for migraine prevention DO NOT TAKE IF YOU ARE PREGNANT or if you are a woman of childbearing potential unless you are USING EFFECTIVE CONTRACEPTION (see ‘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 Topiramate tablets. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topiramate Accord Healthcare 100mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg of Topiramate. Excipient: Also contains 0.53mg soya lecithin (E322). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Topiramate 100mg Film-coated Tablets are yellow, round, biconvex tablets with 10mm diameter and engraved with the marking “V4”. 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 Posology 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. 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 clinical outcome. Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with topiramate may require adjustment of the dose of topiramate. In patients with or without a history of seizures or epilepsy, antiepileptic drugs (AEDs) including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In clinical trials, daily dosages were decreased in Læs hele dokumentet