Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Teva Pharma B.V.
800 Milligram
Film Coated Tablet
2008-09-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Teva 800 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 800 mg film-coated tablet contains 800 mg of gabapentin. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 800 mg: White to off-white, oval shaped, bevelled edged, film-coated tablet. On one side engraved “7174”, and on the other side engraved “93”. 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 TITRATION Day l Day 2 Day 3 300 mg Read the complete document