Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
PCO Manufacturing
50 Milligram
Prolonged Release Capsules
2009-09-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 50mg Prolonged Release Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release hard capsule contains 50mg isosorbide mononitrate Excipient: contains lactose monohydrate and sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard _Product imported from the UK_ Hard capsule with brown cap and flesh coloured body, containing white to beige odourless pellets 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 capsule to be taken in the morning. The dose may be increased up to two capsules per day for patients with higher nitrate requirements. 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 LA has yet to be established in children. Attenuation of effect has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see section 4.4). Treatment with Elantan LA, as with any other nitrate, should not be stopped suddenly. Both dosage and frequency should be tapered gradually (see section 4.4). 4.3 CONTRAINDICATIONS Elantan LA 50 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 pres Read the complete document