Details

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• Marketing Authorization (Malaysia): MAL19992047AZ, indicating approval by the Malaysian National Pharmaceutical Regulatory Agency (NPRA)

• Manufacturer: Merck Sante S.A.S., France

Content

• Active Ingredient: Each tablet contains 500 mg metformin hydrochloride, equivalent to 390 mg metformin base.

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

• Formulation: Film-coated tablet.

• Pack Size: 120 tablets.

• Manufacturer: Merck Sante S.A.S., France.

• Distributor in Malaysia: Merck Sdn. Bhd.

Indications

Glucophage 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.

• Monotherapy or combination therapy with insulin in children aged 10 years and above and adolescents.

• Reduction of diabetic complications in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Instructions for Use

• Dosage:

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

    • The usual starting dose is 500 mg or 850 mg taken 2 or 3 times daily during or after meals.

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

    • The maximum recommended dose is 3 g daily, taken as 3 divided doses.

  • Children aged 10 years and above and adolescents:

    • The usual starting dose is 500 mg or 850 mg taken once daily during or after meals.

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

    • The maximum recommended dose is 2 g daily, taken in 2 or 3 divided doses.

• Administration:

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

  • It is recommended to take the medication at the same time each day.

• Precautions:

  • Contraindicated in patients with hypersensitivity to metformin, metabolic acidosis, diabetic coma, or severely impaired renal function.

  • Use with caution in patients with renal or hepatic impairment.

  • Temporarily discontinue use if dehydration occurs or in the presence of conditions that alter renal function.

  • Monitor renal function regularly during treatment.

  • Avoid alcohol consumption during treatment.