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Metformin

Film-coated tablets 500 mg

Film-coated tablets 850 mg

Film-coated tablets 1000 mg

ATC  A10B A02

Over the counter medicine

Medicines reimbursed by the Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION



Adults

Mono-therapy and Combination with Oral Anti-diabetic Agents

The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.

Combination with Insulin

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements. Elderly Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Mono-therapy and Combination with Insulin

Metformin film-coated tablets can be used in children from 10 years of age and adolescents. – The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

Description

COMPOSITION

Each film-coated tablet contains 500 mg metformin hydrochloride, excipients.
Each film-coated tablet contains 850 mg metformin hydrochloride, excipients.
Each film-coated tablet contains 1000 mg metformin hydrochloride, excipients.

THERAPEUTIC INDICATIONS

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
• In adults, Metformin film-coated tablets may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
• In children from 10 years of age and adolescents, Metformin film-coated tablets may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

CONTRAINDICATIONS

• Hypersensitivity to metformin or to any of the excipients.
• Diabetic ketoacidosis, diabetic pre-coma.
• Moderate (stage 3b) and severe renal failure or renal dysfunction (creatinine clearance < 45 ml/min or estimated glomerular filtration rate < 45 ml/min/1.73m2).
• Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock.
• A disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
• Hepatic insufficiency, acute alcohol intoxication, alcoholism.

PACKAGING

Box with 30 film-coated tablets of 500 mg (3 blisters x 10 tablets).
Box with 30 film-coated tablets of 850 mg (3 blisters x 10 tablets).
Box with 30 film-coated tablets of 1000 mg in a plastic container.