Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
BellPharma Limited
850 Milligram
Tablets
1999-12-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellformin 850 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Metformin hydrochloride 850 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets White coloured, round, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-insulin-dependent diabetes (NIDDM, type II), when adequate dietary treatment has failed. Bellformin 850mg tablets can be given alone as initial therapy, or can be administered in combination with sulphonylureas after careful assessment of the contraindications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Usual dosage: The required daily dose ranges from 0.5 to 3g. Therapy should be initiated with a low dose of one or two tablets daily. Depending on the metabolic state the dose can be increased stepwise at intervals of a few days up to two weeks until the therapeutically required dose has been reached. In order to minimise the gastro-intestinal side-effects the daily dose should be divided and taken with or after meals. Generally, daily doses of 1.5g (two tablets) are sufficient. If diabetic control is incomplete a cautious increase in dosage to a maximum of 3g daily is justified. No additional benefit can usually be achieved by use of doses exceeding 3g daily. Once control has been achieved it may be possible to reduce the daily dose. In cases of metabolic decompensation: In cases of metabolic decompensation - this should be stabilised before the administration of metformin is considered. Children and juveniles: Bellformin 850mg tablets are not recommended for use in children. Bellformin 850mg tablets are not indicated for the treatment of insulin-dependent diabetes (IDDM, type I) in children and juvenile Aqra d-dokument sħiħ