Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
MIGLITOL
Sanofi-Aventis Ireland Limited
100 Milligram
Tablets
2007-03-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diastabol 100 mg tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Diastabol 100 mg tablet contains miglitol 100 mg. For excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to slightly pale yellow, round, biconvex tablet. Diastabol 100 mg tablets are blank on one side and imprinted with ‘MIG 100’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diastabol is recommended as an adjunct to diet or diet and sulfonylureas for the treatment of non-insulin-dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and sulfonylureas. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diastabol tablets are taken orally and should be chewed with the first mouthful of food, or swallowed whole with a little liquid directly before the meal. ADULTS The recommended initial dose is 50 mg three times a day. Depending upon tolerability, the dose should normally be increased to the recommended maintenance dose of 100 mg three times a day after four or twelve weeks’ treatment. ELDERLY PATIENTS No modification of the normal adult dosage regimen is necessary. HEPATIC IMPAIRMENT No dosage adjustment is necessary. RENAL IMPAIRMENT No dosage adjustment is necessary for patients with mild to moderate renal insufficiency (creatinine clearance > 25 ml/min). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/03/2011_ _CRN 2097211_ _page number: 1_ 4.3 CONTRAINDICATIONS o Hypersensitivity to miglitol or to any of the excipients. o Miglitol should not be used in children and individuals less than 18 years of age. o Breast-feeding woman. o Patients with inflammatory bowel disease, colonic Lees het volledige document