Kraj: Malta
Język: angielski
Źródło: Malta Medicines Authority
TOPIRAMATE
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium
N03AX11
TOPIRAMATE 15 mg
HARD CAPSULE
TOPIRAMATE 15 mg
POM
ANTIEPILEPTICS
Authorised
2008-02-05
Page 1 of 9 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX 15 MG HARD CAPSULES TOPAMAX 25 MG HARD CAPSULES TOPAMAX 50 MG HARD CAPSULES 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 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 breastfeeding’ 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 taking Topamax if you: Page 2 of 9 - have kidney problems, especially kidney stones, or are getting kidney dialysis Przeczytaj cały dokument
Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Topamax 15 mg capsules, hard Topamax 25 mg capsules, hard Topamax 50 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 15 mg of topiramate. One capsule contains 25 mg of topiramate. One capsule contains 50 mg of topiramate. Excipients with known effect: Also includes sugar spheres containing not less than 62.5% and not more than 91.5% of sucrose: One 15 mg capsule contains between 28.1 and 41.2 mg sucrose One 25 mg capsule contains between 46.8 and 68.6 mg sucrose One 50 mg capsule contains between 93.7 and 137.2 mg sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. 15 mg: Small white to off-white spheres in Size 2 hard gelatin capsules with white opaque body marked '15 mg’ and clear cap marked 'TOP'. 25 mg: Small white to off-white spheres in Size 1 hard gelatin capsules with white opaque body marked '25 mg’ and clear cap marked 'TOP'. 50 mg: Small white to off-white spheres in Size 0 hard gelatin capsules with white opaque body marked '50 mg’ and clear cap marked 'TOP'. 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 generalisation or primary generalised 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. Page 2 of 25 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 gu Przeczytaj cały dokument