Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
GLIBENCLAMIDE
Sanofi-Aventis Ireland Limited
5 Milligram
Tablets
1999-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daonil 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glibenclamide 5mg. Excipients: contains Lactose Monohydrate 79.0mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White biplane, oblong tablets with ‘LDI’ engraved on each side of scoreline and inverted on one side, the other side is plain. The score line present allows the tablet to be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daonil is a sulphonylurea hypoglycaemic agent, indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of glibenclamide must be the lowest possible dose which is effective. The usual total daily dosage is 2.5mg to 15mg daily with a usual initial dose of 5mg daily. Weekly adjustments can be made to increase the dosage to the optimal level. Doses of 10mg or less may be taken as a single dose immediately before breakfast, but should the daily dose exceed 10mg, the remainder should be taken immediately before the evening meal. The elderly usually require lower dosage. DOSE OMISSION A physician should be consulted in the event that a dose has not been taken at the prescribed time, a meal has been skipped or an extra dose has been taken. It is very important not to skip meals after the tablets have been taken. SECONDARY DOSAGE ADJUSTMENT As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glibenclamide requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Daonil therapy must therefore be considered. Correction of dosage must Lue koko asiakirja