Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
20 Milligram
Tablets
2009-05-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of isosorbide mononitrate. Excipients: Contains Lactose Monohydrate 151.7mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White tablets with break-score and marked ‘E20’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and long term management of angina pectoris. As adjunctive therapy after acute myocardial infarction and chronic congestive heart failure. 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 dosage and frequency should be tapered gradually (see section 4.4). 4.3 CONTRAINDICATIONS Elantan 20 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 pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage. IRISH MEDICI Read the complete document