Marketing Authorization (Malaysia): MAL19992049AZ, 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.
Active Ingredient: Each film-coated tablet contains 1000 mg metformin hydrochloride, corresponding to 780 mg metformin base.
Excipients: Povidone K30, magnesium stearate, and hypromellose.
Formulation: White, oval, biconvex film-coated tablets with a score line on both sides, engraved with "1000" on one side. The tablet can be divided into equal halves.
Pack Size: 120 tablets.
Manufacturer: Merck Sante S.A.S., France; marketed and distributed in Malaysia by Merck Sdn. Bhd.
Glucophage 1000mg 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.
Dosage:
Adults with normal renal function (GFR ≥90 mL/min):
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 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 metformin hydrochloride 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.
Malaysia
