Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Metformin hydrochloride
MERCK PTE. LTD.
A10BA02
1000mg
TABLET, FILM COATED
Metformin hydrochloride 1000mg
ORAL
Prescription Only
Merck Santé s.a.s.
ACTIVE
2002-05-21
21 0 65 35 M C- 15 21 -2 01 4 10 1 mini 10 12 12 170 170 170 170 12 12 Page 2 Page 3 Page 4 Page 1 2 1 1 1 mini CODE 128A SUR COTE EXT BOBINE (CENTRE) CODE 128A ON OUTSIDE BOBBIN (CENTER) 12 65 35 21 0 10 10 10 12 12 10 21 0 12 10 21 0 M C-1 52 1-2 01 4 Co de a rtic le Le afl et co de CODE 128A SUR COTE EXT BOBINE (CENTRE) CODE 128A ON OUTSIDE BOBBIN (CENTER) CODE 128A SUR COTE INT BOBINE (CENTRE) CODE 128A ON INSIDE BOBBIN (CENTER) Code article Leaflet code Page 1 Page 1 Page 1 170 12 12 82.6 2 210 ±0.5 70 -7 6 MAX. 600 35 35 21 0 65 65 M C- 152 1- 20 14 1. NAME OF THE MEDICINAL PRODUCT GLUCOPHAGE 500 mg, film-coated tablet. GLUCOPHAGE 850 mg, film-coated tablet. GLUCOPHAGE 1000 mg, film-coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Glucophage 500 mg film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. Each Glucophage 850 mg film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base. Each Glucophage 1000 mg film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Glucophage 500 mg and Glucophage 850 mg tablets are white, circular, convex and film-coated. Glucophage 1000 mg tablets are white, oval, biconvex and film-coated with a line on both sides with “1000” engraved on one side. The tablet can be divided into equal halves. 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 film-coated tablets 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 film-coated tablets may be used as monotherapy or in Preberite celoten dokument
1. NAME OF THE MEDICINAL PRODUCT GLUCOPHAGE 500 mg, film-coated tablet. GLUCOPHAGE 850 mg, film-coated tablet. GLUCOPHAGE 1000 mg, film-coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Glucophage 500 mg film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. Each Glucophage 850 mg film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base. Each Glucophage 1000 mg film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Glucophage 500 mg and Glucophage 850 mg tablets are white, circular, convex and film- coated. Glucophage 1000 mg tablets are white, oval, biconvex and film-coated with a line on both sides with “1000” engraved on one side. The tablet can be divided into equal halves. 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 film-coated tablets 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 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 as first-line therapy after diet failure (see section 5.1). 4.2. Posology and method of administration Oral route Adults with normal renal function (GFR > 90mL/min): Monotherapy and combination with other oral antidiabetic agents: The usual starting dose is one tablet of Glucophage 500 mg or 850 mg 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 gastro Preberite celoten dokument