DIABETMIN Prolonged release tablet Ref.[50345] Active ingredients: Metformin

Posology

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

Reduction in the risk or delay of the onset of type 2 diabetes

• Metformin should only be considered where intensive lifestyle modifications for 3 to 6 months have not resulted in adequate glycaemic control.

• The therapy should be initiated with one tablet Diabetmin XR prolonged release tablet once daily with the evening meal.

• After 10 to 15 days dose adjustment on the basis of blood glucose measurements is recommended (OGTT and/or FPG and/or HbA1C values to be within the normal range). A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dose is 4 tablets (2000 mg) once daily with the evening meal.

• It is recommended to regularly monitor (every 3-6 months) the glycaemic status (OGTT and/or FPG and/or HbA1c value) as well as the risk factors to evaluate whether treatment needs to be continued, modified or discontinued.

• A decision to re-evaluate therapy is also required if the patient subsequently implements improvements to diet and/or exercise, or if changes to the medical condition will allow increased lifestyle interventions to be possible.

Monotherapy in Type 2 diabetes mellitus and combination with other oral antidiabetic agents

• The usual starting dose is one tablet of Diabetmin XR 500 mg once daily.

• After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dose is 4 tablets of Diabetmin XR 500 mg daily.

• Dosage increases should be made in increments of 500 mg every 10-15 days, up to a maximum of 2000 mg once daily with the evening meal. If glycaemic control is not achieved on Diabetmin XR 2000 mg once daily, Diabetmin XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

• In patients already treated with metformin tablets, the starting dose of Diabetmin XR prolonged release tablet should be equivalent to the daily dose of metformin immediate release tablets. In patients treated with metformin at a dose above 2000 mg daily, switching to Diabetmin XR prolonged release tablet is not recommended.

• If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate Diabetmin XR prolonged release tablet at the dose indicated above.

Combination with insulin

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of Diabetmin XR prolonged release tablet is one 500 mg tablet once 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 (see section 4.4).

Benefit in the reduction of risk or delay of the onset of type 2 diabetes mellitus has not been established in patients 75 years and older (see section 5.1) and metformin initiation is therefore not recommended in these patients (see section 4.4).

Patients with renal impairment

A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

Paediatric population

In the absence of available data, Diabetmin XR prolonged release tablet should not be used in children.

Hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.

2 years (24 months).

Store below 30°C, protect from light and moisture.

Alu/PVC/PVDC Blister Of 10 × 10’s.

No special requirements.