Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Pliva Pharma Limited
800 Milligram
Film Coated Tablet
2008-12-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin 800 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 800 mg film-coated tablet contains 800 mg of gabapentin. Excipient: Lecithin of soya: 0.84 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, capsule-shaped film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization 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 generalization 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 Oral use. Gabapentin can be given with or without food and should be swallowed whole with sufficient fluidintake (e.g. a glass of water). For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section. Table 1 DOSING CHART - INITIAL TITRATION Day 1 Day 2 Day 3 300 mg once a day 300 mg two times a day 300 mg three times a day IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/11/2010_ _CRN 2090228_ _page number: 1_ Discontinuation of gabapentin In accordance with curren Les hele dokumentet