Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
25 Milligram
Prolonged Release Capsules
2009-06-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 25mg Prolonged Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule contains 25 mg isosorbide mononitrate. Excipients: Each prolonged release capsule contains 6.71mg lactose monohydrate and 8.17-11.96mg sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged- release capsule, hard Hard capsule with brown cap and white body, containing white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the prophylaxis of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. ADULTS One capsule to be taken in the morning. For patients with higher nitrate requirement, the dose may be increased to two capsules taken simultaneously. 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 25 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 LA25 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 Baca dokumen lengkap