GABAPENTIN PFIZER
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
GABAPENTIN
Available from:
Pfizer Healthcare Ireland
Dosage:
600 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-09-23
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin Pfizer 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of gabapentin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Gabapentin Pfizer 600 mg film-coated tablets are white, elliptical film-coated tablets (length and width: 8.96 x
17.27 mm; thickness: 6.48 mm) with a bisecting score on both sides and debossed with “NT” and “16” on one side.
The tablet can be divided into equal halves.
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 all
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