País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metformin (metformin hydrochloride)
Arpimed LLC
metformin (metformin hydrochloride)
1000mg
tablets film-coated
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS METFORMIN 1000 MG COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT - Metformin NON-PROPRIETARY NAME - Metformin 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Each coated tablet contains: ACTIVE INGREDIENT: Metformin hydrochloride - 1000 mg (equivalent to 780 mg of metformin); For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM White round biconvex coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control. In adults, Metformin 1000 mg coated tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. In children from 10 years of age and adolescents, Metformin 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 A dose of 850 mg is not possible with Metformin 1000 mg. Another appropriate formulation should be used for a dose of 850 mg. 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 the gastro-intestinal tolerability. In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Metformin 500 mg coated tablets with one Metformin 1000 mg coated tablet. 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, the other agent should be discontinued and metformin initiated at the dose indicated above. _ _ COM Leia o documento completo