Marketing Authorization (Malaysia): MAL15065037AZ, 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 extended-release tablet contains 1000 mg metformin hydrochloride, corresponding to 780 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 on one side with '1000' and on the other side with 'Merck'.
Pack Size: 60 tablets.
Manufacturer: Merck Sante S.A.S., France; marketed and distributed in Malaysia by Merck Sdn. Bhd.
Glucophage XR 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.
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.
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:
Precautions:
Contraindicated in patients with hypersensitivity to metformin, metabolic acidosis, diabetic coma, or severely impaired renal function (GFR <30 mL/min).
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
