Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Metformin hydrochloride
MERCK PTE. LTD.
A10BA02
500 mg
TABLET, EXTENDED RELEASE
Metformin hydrochloride 500 mg
ORAL
Prescription Only
Merck Sante sas (Semoy)
ACTIVE
2007-04-12
M C-1 52 9- 20 14 code placeholder code placeholder 1. NAME OF THE MEDICINAL PRODUCT Glucophage XR 500 mg extended release tablet Glucophage XR 750 mg extended release tablet Glucophage XR 1000 mg extended release tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One Glucophage XR 500 mg extended release tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. One Glucophage XR 750 mg extended release tablet contains 750 mg metformin hydrochloride corresponding to 585 mg metformin base. One Glucophage XR 1000 mg extended release tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended release tablet Glucophage XR 500 mg : White to off-white, capsule-shaped, biconvex tablet, debossed on one side with “500” Glucophage XR 750 mg: White to off-white,capsule-shaped, biconvex tablet, debossed on one side with '750' and on the other side with 'Merck'. Glucophage XR 1000 mg: White to off-white, capsule-shaped, biconvex tablet, debossed on one side with “1000” and on the other side with 'Merck'. 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 glycaemic control. Glucophage XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Monotherapy and combination with other oral antidiabetic agents._ Glucophage XR 500 mg • The usual starting dose of Glucophage XR 500 mg is one tablet once daily with the evening meal. • Glucophage XR tablets must be swallowed whole and never crushed or chewed. • After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. • To improve gastrointestinal Read the complete document
MERCK GLUCOPHAGE XR 500MG – 750MG – 1000MG EXTENDED RELEASE TABLETS METFORMIN HYDROCHLORIDE 1. NAME OF THE MEDICINAL PRODUCT Glucophage XR 500 mg extended release tablet Glucophage XR 750 mg extended release tablet Glucophage XR 1000 mg extended release tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One Glucophage XR 500 mg extended release tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. One Glucophage XR 750 mg extended release tablet contains 750 mg metformin hydrochloride corresponding to 585 mg metformin base. One Glucophage XR 1000 mg extended release tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended release tablet Glucophage XR 500 mg: White to off-white, round shaped, biconvex tablet, debossed on one side with “500” Glucophage XR 750 mg: White to off-white, capsule-shaped, biconvex tablet, debossed on one side with '750' and on the other side with 'Merck'. Glucophage XR 1000 mg: White to off-white, capsule-shaped, biconvex tablet, debossed on one side with “1000” and on the other side with 'Merck'. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG* who are: - at high risk for developing overt type 2 diabetes mellitus (see section 5.1) and - not suitable for intensive lifestyle modifications. Treatment with Glucophage XR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk (see section 5.1). *IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose • Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Glucophage XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 4 Read the complete document