Product Description

Posology

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

Monotherapy and combination with other oral antidiabetic 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 (see section 4.4).

Renal impairment

Metformin may be used in patients with moderate renal impairment, stage 3a (creatinine clearance [CrCl] 45– 59 mL/min or estimated glomerular filtration rate [eGFR] 45 -59 mL/min/1.73m2) and stage 3b (estimated GFR 30-44 ml/min) only in the absence of other conditions that may increase the risk of lactic acidosis and with the following dose adjustments:

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.

If eGFR falls <30 ml/min, metformin must be discontinued immediately

- The total maximum daily dose for patients with GFR 60-89 mL/min should be the same as the currently approved dose in adults with normal renal function.

Paediatric population

Monotherapy and combination with insulin

• Metformin 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.