País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
IPS Healthcare Limited
25 Milligram
Prolonged Release Capsules
2011-11-11
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. Contains sucrose and lactose For a full list excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Capsules _Product imported from the UK:_ 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 a head trauma and including cerebral haemorrhage. IR Llegiu el document complet