SIOFOR Prolonged-release tablet Ref.[49802] Active ingredients: Metformin

Posology

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

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

• The usual starting dose is one tablet of Siofor SR 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 Siofor SR 500 mg prolonged-release tablets 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 Siofor SR 2000 mg once daily, Siofor SR 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 Siofor SR 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 Siofor SR is not recommended.
• If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate Siofor SR at the dose indicated above.

Combination with insulin

Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of Siofor SR is one 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).

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, Siofor SR should not be used in children.

Method of administration

The tablets should be swallowed whole with a drink of water. They should not be chewed or crushed.

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.

3 years.

This medicinal product does not require any special storage conditions.

15, 30, 60, 90 or 120 prolonged-release tablets in blister strips composed of aluminium foil and PVC.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.