Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
500 Milligram
Film Coated Tablet
2001-02-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerformin 500mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500mg metformin hydrochloride corresponding to 390 mg metformin base. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, circular convex film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary managements and exercise alone does not result in adequate glycaemic control. o In adults, Gerformin 500mg film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. o In Children form 10 years of aged and adolescents, Gerformin 500mg film-coated tablets may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure (_see section 5.1, Pharmacodynamic properties_). A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure (_see section 5.1, Pharmacodynamic properties _). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: _Monotherapy and combination with other oral antidiabetic agents:_ The usual starting dose is one tablet 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. Read the complete document