Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Topiramate
Phoenix Healthcare Distribution Ltd
N03AX11
Topiramate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100
PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX ® 100MG 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. The name of your medicine is Topamax 100mg Tablets, but will be referred to as Topamax throughout the remainder of this leaflet. Topamax is also available in other strengths. WHAT IS IN THIS LEAFLET 1) What Topamax is and what it is used for 2) What you need to know before you take Topamax 3) How to take Topamax 4) Possible side effects 5) How to store Topamax 6) Contents of the pack and other information 1) WHAT TOPAMAX IS AND WHAT IT IS USED FOR Topamax belongs to a group of medicines called “anti-epileptic 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 TOPAMAX DO NOT TAKE TOPAMAX if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6) 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. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before Baca dokumen lengkap
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 Baca dokumen lengkap