Details

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• Marketing Authorization (Malaysia): MAL07050002AZ, indicating approval by the Malaysian National Pharmaceutical Regulatory Agency (NPRA).

• Manufacturer: Merck Sante S.A.S., France; marketed and distributed in Malaysia by Merck Sdn. Bhd.

Content

• Active Ingredient: Each extended-release tablet contains 500 mg metformin hydrochloride, corresponding to 390 mg metformin base.

• Excipients: For a full list of excipients, please refer to the product's Summary of Product Characteristics.

• Formulation: White to off-white, capsule-shaped, biconvex tablet, debossed with "500" on one side.

• Pack Size: 60 tablets.

• Manufacturer: Merck Sante S.A.S., France; marketed and distributed in Malaysia by Merck Sdn. Bhd.

Indications

Glucophage XR 500mg Tablets are indicated for:

• Monotherapy or combination therapy with other oral antidiabetic agents or insulin for the treatment of type 2 diabetes mellitus in adults when dietary management and exercise alone do not result in adequate glycaemic control.

• Reduction of the risk or delay of the onset of type 2 diabetes mellitus in overweight adults with impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and/or increased HbA1c who are at high risk for developing overt type 2 diabetes mellitus and still progressing towards type 2 diabetes mellitus despite implementing intensive lifestyle changes for 3–6 months.

Instructions for Use

• Dosage:

  • Adults with normal renal function (GFR ≥90 mL/min):

    • The usual starting dose is 500 mg taken once daily with the evening meal.

    • After 10 to 15 days, the dose should be adjusted based on blood glucose measurements.

    • The maximum recommended dose is 2000 mg daily, taken as a single dose with the evening meal.

  • Transfer from other oral antidiabetic agents:

    • Discontinue the other agent and initiate Glucophage XR at the same daily dose.

  • Combination with insulin:

    • Initiate Glucophage XR at 500 mg daily with the evening meal.

    • Adjust the insulin dose based on blood glucose measurements.

• Administration:

  • Swallow the tablet whole with water. Do not chew, crush, or break the tablet.