Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
850 Milligram
Film Coated Tablet
2001-02-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerformin 850 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. White, circular convex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. 1. In adults, Gerformin 850 mg film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. 2. In children from 10 years of age and adolescents, Gerformin 850 mg 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_). 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. If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin hydrochloride at the dose indicated above. _Combination with insulin:_ Metformin hydrochloride and insulin may be used in Read the complete document