Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CARBASALATE CALCIUM
Meda Health Sales Ireland Limited
100 Milligram
Tablets Effervescent
2006-06-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ascal Brisper Cardio-Neuro 100 mg effervescent tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One effervescent tablet contains 100 mg carbasalate calcium, corresponding to 78 mg acetyl salicylic acid. Excipient: contains Lactose Monohydrate 150.0 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. White- to cream-coloured, round, flat tablet with bevelled edge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ascal is indicated for secondary prevention after a first myocardial or cerebrovascular event linked to atherosclerosis : • Myocardial infarction • Unstable and stable angina pectoris • Stroke and transient ischaemic attack provided that intracanial haemorrhages are excluded. • Graft occlusion after aorta-coronary bypass. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Secondary prevention of myocardial infarction:_ In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 to 2 effervescent tablets (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid, to 200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day. In acute cases, the first dose must be taken as soon as possible after the diagnosis. _Secondary prevention of unstable and stable angina pectoris:_ In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 to 2 effervescent tablets (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid, to 200 mg carbasalate calcium, Läs hela dokumentet