metformin (Glucophage SR)

Following a 2nd resubmission:

metformin hydrochloride prolonged release tablets (Glucophage SR®) are accepted for restricted use for the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

This new formulation appears to have similar short-term efficacy to immediate-release metformin. Evidence of improved gastrointestinal tolerability is not convincing and the prolonged-release formulation is more expensive than the immediate-release formulation.

It is restricted to use in patients who are intolerant of immediate release metformin and in whom the prolonged release tablet allows the use of a dose of metformin not previously tolerated or in patients for whom a once-daily preparation offers a clinically significant benefit.