Approved country
500 mg : UK, Czech, Latvia,
Hungary, The Netherlands, Poland
750mg : UK, Ireland, The
Netherlands, Poland
1000mg : UK, The Netherlands,
Poland
Composition
500 mg: One prolonged
release tablet contains 500 mg metformin hydrochloride equivalent to 390 mg
metformin.
750 mg: One prolonged
release tablet contains 750 mg metformin hydrochloride
equivalent to 585 mg metformin .
1000 mg: One prolonged
release tablet contains 1000 mg metformin hydrochloride equivalent to 780 mg
metformin .
Pharmaceutical
Form
Prolonged-release tablet
500 mg: White, shallow convex,
capsule-shaped tablet marked “XR” on one side , and blank on the other
side, dimension : 20x9mm.
750 mg: White, shallow convex,
capsule-shaped tablet marked “SR 1” on one side, and blank on the other
side, dimension : 20x9mm.
1000 mg: White, shallow convex,
capsule-shaped tablet marked “SR 2” on one side, and blank on the other
side, dimension : 22.25x9mm.
Therapeutic indications
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.
METFORMIN SR may be used as
monotherapy or in combination with other oral antidiabetic agents, or with
insulin
Type of container
500mg:
PVC/PVDC aluminium blisters.
Blister packs of 28, 30, 56, 60 & 120
prolonged-release tablets.
750mg:
PVC/PVDC aluminium blisters.
Blister packs of 28, 30, 56, 60 & 120
prolonged-release tablets.
1000mg:
PVC/PVDC aluminium blisters.
Blister packs of 28, 30, 56, 60 & 120
prolonged-release tablets.
Shelf life
Shelf life as packaged for sale: 36
months
ID
