GLUCOPHAGE 500MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

MERCK SANTE S.A.S.

Ciri produk

N
AME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 500 mg film -coated tablets
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
One film -coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg
metformin ba se.
F
or a full list of excipients, see sect ion List of excipients.
P
HARMACEUTI CAL FORM
Film -coated tablet.
White, circular, convex film -coated tablets.
C
LI NI CAL PARTI CULARS
Therapeutic indications
Treatment of type 2 diabetes mellitus, when dietary manag ement and exercise alone does not result
in adequate g lycaemic control.
- In adults, GLUGOPHAGE® 500 mg film -coated tablet may be used as monotherapy or in
combination with other oral anti -diabetic ag ents or with insulin.
- I n children from 10 years of ag e and adolescents, GLUGOPHAGE® 500 mg film-coated tablet may be used a s monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweig ht type 2 diabetic adult patients
treated with metformin as first- line therapy after diet failure (see Pha rmacodynamic properties) .
P
osology and method of administration
Adults with normal renal function (GFR ≥ 90 mL/min) :
Monotherapy and combination with other oral antidiabetic agents:
- The usual starting dose is one tablet 2 or 3 times daily g iven during or after meals. After 10 to 15
days the dose should be adjusted on the basis of blood g lucose measurements. A slow increase of
dose may improve gastrointestinal tolerability.
- The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided
doses.
- I f transfer from another oral antidiabetic ag ent is intended: discontinue the other ag ent and initiate
metformin at the dose indicated above.
Combination with insulin:
Metformin and insulin may be used in combination therapy to achieve be tter blood g lucose control.
Metformin hydrochloride is g iven at the usual starting dose of one tablet 2 or 3 times daily, while
insulin dosag e is adjusted on the basis of blood g lucose measurements.