Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID
Flamel Technologies SA
162.5 Milligram
Capsule
1999-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ASACARD 162.5 mg prolonged release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains acetylsalicylic acid 162.5 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard The capsules have a white body and red cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASACARD 162.5 mg Capsules are indicated for secondary prophylaxis after a first coronary or cerebrovascular ischemic event: • myocardial infarction • stable and unstable angina • coronary angioplasty • transient ischemic attack (TIA) • non-haemorrhagic stroke • reduction of graft patency occlusion after CABG In situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or unstable angina) then conventional (immediate release acetylsalicylic acid) should be given. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ASACARD 162.5 mg Capsules should not be taken without first seeking medical advice on the suitability of treatment. Treatment should be long-term and under medical supervision. Swallow the capsule with water. _Adults:_ One ASACARD 162.5 mg capsule per day (162.5 mg). It is recommended that the capsules are taken at the same time each day e.g. in the morning, approximately 15 minutes before food. _Elderly:_ The usual adult dose is recommended in the absence of severe renal or hepatic insufficiency (see contraindications and warnings). _Children:_ Do not give to children and adolescents under 16 years (see section 4.4). 4.3 CONTRAINDICATIONS • Peptic ulcer and/or gastrointestinal haemorrhages IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/11 Läs hela dokumentet