Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
Merck Serono Limited
1000 Milligram
Powder for Oral Solution
2010-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucophage 1000 mg powder for oral solution in sachets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. Excipients: contains aspartame. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. White, odourless powder 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, Glucophage 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, Glucophage 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 as first-line therapy after diet failure (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: _Monotherapy and combination with other oral antidiabetic agents:_ The usual starting dose is 500 mg or 850 mg metformin hydrochloride 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. In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg doses with one Glucophage 1000 mg dose. 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 Olvassa el a teljes dokumentumot