Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metformin (metformin hydrochloride)
Artesan Pharma GmbH & Co. KG
metformin (metformin hydrochloride)
850mg
tablets film-coated
Prescription
___________________________________________________________________________ Enclosure SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT METFO_gamma_ ® 850 Active ingredient: metformin hydrochloride, film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Each film-coated tablet contains 850 mg of metformin hydrochloride, corresponding to 663 mg of metformin. For a complete list of other constituents please see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Therapy of type 2 diabetes mellitus; particularly in overweight patients in whom diet and physical activity alone are not able to achieve sufficient adjustment of blood sugar lev- els. - In adults METFO_gamma_ ® 850 can be administered in the form of a monother- apy or in combination with other oral antidiabetics or insulin. - In children aged 10 and up and adolescents METFO_gamma_ ® 850 can be ad- ministered in the form of a monotherapy or in combination with insulin. Page: 1 of 12 In overweight adult patients with type 2 diabetes mellitus it has been possible to show that after the failure of dietary measures metformin hydrochloride is the therapy of first choice for reducing the frequency of diabetes-induced complications (see 5.1 "Pharmacodynamic Properties"). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _ _Monotherapy and Combination with Other Oral Antidiabetics _ - In general the initial dose consists of the administration of 1 film-coated tablet con- taining 500 mg or 850 mg of metformin hydrochloride two or three times a day dur- ing or after meals. After 10 to 15 days the dosage should be adapted in accor- dance with measurements of the blood sugar levels. A slow increase in dosage has a positive effect on the gastrointestinal tolerance of the medication. The maximum recommended dose is 3 g of metformin hydrochloride a day. - In the event of a changeover from a different oral antidiabetic to metformin hydro- chloride the medication taken Soma hati kamili