Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
BellPharma Limited
500 Milligram
Tablets
1999-12-10
License Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Bellformin 500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Metformin hydrochloride 500 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 500mg 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 (1-6 tablets). 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 (three tablets) are sufficient. If diabetic control is incomplete a cautious increase in Read the complete document