Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Milpharm Limited
GABAPENTIN
400 Milligram
Capsule
Product subject to prescription which may be renewed (B)
Withdrawn
2013-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabture 400mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 400mg Gabapentin Each hard capsule contains 67.333mg lactose monohydrate For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard (Capsules) Size ‘0’ orange/orange hard gelatine capsule marked ‘MG 400’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults and children aged 6 years and above (see section 5.1). Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalisation in adults and adolescents aged 12 years and above. Treatment of peripheral neuropathic pain: Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post- herpetic neuralgia in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid intake (e. g. glass of water) For all indications a titration scheme of the initiation of therapy is described in Table 1, which is recommended in adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under separate sub-heading later in this section. Table 1 Discontinuation of Gabapentin In accordance with current clinical practice, if Gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication. Dosing chart – initial titration Day 1 Day 2 Day 3 300mg once a day 300mg two times a day 300mg three ti Läs hela dokumentet