Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
10 Milligram
Tablets
2009-06-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg isosorbide mononitrate. Also contains 154 mg lactose (as monohydrate). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, circular, flat, bevelled-edge tablets with scoreline, marked ‘E/10’ on one side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and long term management of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. The dosage may be increased up to 120 mg per day. Dosage regime should be designed according to the clinical response of the patient. Tablets should be taken after meals, unchewed with a little fluid. The lowest effective dose should be used. Elderly There is no evidence to suggest that an adjustment of the dosage is necessary. Children The safety and efficacy of Elantan has yet to be established in children. Treatment with Elantan, as with any other nitrate, should not be stopped suddenly. Both the frequency and dosage should be tapered gradually (see section 4.4). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/11/2011_ _CRN 2107252_ _page number: 1_ 4.3 CONTRAINDICATIONS Elantan 10 should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or very low blood pressure, hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericar Aqra d-dokument sħiħ