TOPIRAMA 25MG CAPSULES, HARD 25 Milligram Capsule
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
31-05-2024
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
TOPIRAMATE
Inapatikana kutoka:
Arrow Generics Limited
INN (Jina la Kimataifa):
TOPIRAMATE
Kipimo:
25 Milligram
Dawa fomu:
Capsule
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2012-07-16
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topirama 25mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25mg of topiramate.
Each capsule also contains 69 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 ‘25’ 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 medici
Soma hati kamili
