Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
1000 Milligram
2009-06-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerformin 1000 mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metformin 1000mg dispersible tablets: Each tablet contains 1000mg Metformin, as Metformin hydrochloride corresponding to 780 mg metformin base. Excipients: sulphurous anhydride (E220), maltodextrin For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible tablet A white, marbled and oblong dispersible tablets with 2 lines. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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. • _IN ADULTS_, GERFORMIN 1000 mg dispersible tablet may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. • _IN CHILDREN FROM 10 YEARS OF AGE AND ADOLESCENTS_, GERFORMIN 1000mg dispersible tablet 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY_ _ADULTS:_ Monotherapy and combination with other oral antidiabetic agents: • The usual starting dose is one tablet of GERFORMIN 500 mg or 850 mg, dispersible 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 da Read the complete document