Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCERYL TRINITRATE
Forest Laboratories UK Ltd
GLYCERYL TRINITRATE
2.0 mg Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Withdrawn
2012-12-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Suscard Buccal Tablet 2 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of glyceryl trinitrate as Diluted Nitroglycerin. Also contains 19.89mg of Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release Buccal Tablet. White, biconvex, round tablets having the number ‘2’ imprinted on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management and treatment of angina pectoris. This product may also be of benefit in the in-patient management of unstable angina. For the treatment of acute and congestive cardiac failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults (including the elderly) _Angina:_ Administration of Suscard Tablets should start with the 2mg strength. If angina occurs while the tablet is in place, the dosage strength used should be increased to 3mg where necessary. The 5mg dosage strength should be reserved for patients with severe angina pectoris refractory to treatment with the lower dosage strengths. A 1 mg dosage strength is also available and may be considered for the small number of patients who may initially show intolerance to the 2 mg strength as a starting dose. Suggested dosage frequency in angina: a) For patients suffering only occasional angina pectoris – the tablets may be administered on a p.r.n. basis to relieve the acute attack. b) For patients suffering angina pectoris in response to known stimuli - the tablet should be administered a few minutes prior to encountering the angina-precipitating stimulus. c) For patients in whom chronic therapy is indicated - the tablet should be administered on a thrice-daily basis or as indicated by the dissolution rate of the tablet Read the complete document