Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
GABAPENTIN
WPR Healthcare Limited
300 Milligram
Capsules Hard
2011-05-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Teva 300mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 300mg gabapentin Excipients: contains sunset yellow (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard _Product imported from the UK:_ Hard gelatin capsules with a brown cap and body printed with the numbers “93 and “39” and filled with a white to off white powder with small agglomerates. 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 For oral use. Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (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 l Day 2 Day 3 300 mg once a day 300 mg two times a day 300 mg three times a day IRISH MEDICINES BOARD _______________________________________________________________________________ Baca dokumen lengkap