Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
Arrow Generics Limited
TOPIRAMATE
15 Milligram
Capsule
Product subject to prescription which may be renewed (B)
Withdrawn
2012-07-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topirama 15mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15mg of topiramate. Each capsule also contains 41.4 mg of sucrose. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard (capsule). White opaque body and white opaque cap. The body has ‘15’ printed in black and the cap has ‘>’ over ‘Ti’ printed in black. 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 tablet and a hard capsule formulations. 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. Topirama Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This medi Prečítajte si celý dokument