País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID
Mayne Pharma (Ireland) Limited
ACETYLSALICYLIC ACID
75 Milligram
Tablets
Withdrawn
2006-01-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lowasa Tablets 75 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75mg Aspirin (acetylsalicylic acid) 3 PHARMACEUTICAL FORM White, uncoated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aspirin has analgesic, antipyretic and anti-inflammatory actions and an antithrombotic effect through inhibition of platelet activation. This preparation is indicated for the prophylactic management of cardiovascular disease or myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION The tablets should be dispersed in water before administration, and taken immediately. Adults including elderly: The usual dose is 75-150mg daily. Children: Do not give to children and adolescents under 16 years, except on medical advice, where the benefit outweighs the risk. 4.3 CONTRAINDICATIONS Aspirin should not be taken by patients with a known idiosyncrasy to aspirin or other nonsteroidal anti-inflammatory drugs or those suffering from active peptic ulceration or coagulation disorders. Children particularly those under 16 years of age, unless advised by a doctor. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Patients treated with Aspirin long-term should undergo regular medical supervision to monitor for adverse events. Elderly patients are particularly susceptible to the adverse effects of NSAIDs. There is possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children and adolescents under 16 years unless specifically indicated. Aspirin should be used with caution in patients with a history of peptic ulceration, inflammatory bowel disease or coagulation abnormalities. It may induce gastrointestina Llegiu el document complet