Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
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 (see section 5.1).
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.
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.
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).
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.
| GFR (mL/min) | Total maximum daily dose (to be divided into 2-3 daily doses) | Additional considerations |
|---|---|---|
| 60-89 | 3000 mg | Dose reduction may be considered in relation to declining renal function. |
| 45-59 | 2000 mg | Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin. The starting dose is at most half of the maximum dose. |
| 30-44 | 1000 mg | |
| <30 | - | Metformin is contraindicated. |
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.
Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks 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.
5 years.
This medicinal product does not require any special storage conditions.
1 (x100), 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or 1000 tablets in blister packs (PVC-aluminium)
21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 or 1000 tablets in plastic bottles (high-density polyethylene) with child-resistant caps (polypropylene).
Not all pack sizes may be marketed.
1 (x 100), 8, 9, 10,14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 or 1000 tablets in blister packs (PVC-aluminium)
30, 60, 200, 300 or 600 tablets in plastic bottles (high-density polyethylene) with caps (polypropylene),
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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