Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
80 Milligram
Tablets
2000-07-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diaclide 80mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Gliclazide 80mg. Excipients: Each tablet contains 40 mg Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White round, flat, bevel edged, scored tablets, marked ‘GZ80’ on one side with a ‘G’ on the other. The scoreline allows the tablets to be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diaclide is used for the treatment of maturity onset diabetes mellitus, where therapy with insulin is not required and dietary modifications have failed to control hyperglycaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diaclide is for oral administration. Adults The total dose may vary from 40-320 mg daily. A single dose should not exceed 160 mg (2 tablets) and when higher doses are required a twice daily split dosage is advised and should be divided according to the main meals of the day. The final dosing regimen will be decided by the doctor and will be dependent upon individual patient requirements. The tablet is to be taken with food and in conjunction with a calorie and carbohydrate restricted diet. Diaclide may be used in combination with biguanide hypoglycaemic drugs if necessary. Elderly As for adults. Children Diaclide is contraindicated in children. 4.3 CONTRAINDICATIONS Diaclide should not be used in pregnant women or women who are breastfeeding, children, patients with known hypersensitivity to gliclazide or other sulphonylureas, diabetes complicated by ketoacidosis, severe renal, hepatic, adrenal or thyroid dysfunction or in patients with unstable or brittle diabetes. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE IRISH MEDICINES BOARD _________ Read the complete document