Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GABAPENTIN
WPR Healthcare Limited
400 Milligram
Capsules Hard
2011-05-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Teva 400mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400mg gabapentin 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 orange cap and body printed with the numbers “93" and “40” 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 _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. Table 1 DOSING CHART - INITIAL TITRATIO Read the complete document