Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID
Bayer PLC
320 Milligram
Tablets
2005-07-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspro Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylsalicylic acid (Aspirin) 320 mg/tablet. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to creamy white biconvex circular tablets. One side is impressed with the word ‘Aspro’, the letters being radially arranged around the periphery. The other face is bisected with a breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of symptoms associated with headache, rheumatic, muscular or neuralgic pain, toothache, common cold, influenza, fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Oral. ADULTS: Adults and children over 12 years: one to two tablets every four hours as required. Do not exceed twelve tablets in 24 hours unless directed by a doctor. ELDERLY: Aspirin should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also Section 4.4. CHILDREN: Do not give to children under 12 unless your doctor tells you to. 4.3 CONTRAINDICATIONS Active peptic ulceration. As aspirin can interfere with platelet function, aspirin should not be used in patients with bleeding diatheses such as haemophilia. History of hypersensitivity reactions (bronchospasm, rhiniris and urticaria) to aspirin, other non-steroidal anti- inflammatory drugs or any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use except under medical supervision can be harmful. If symptoms persist, the physician should be consulted. If you are taking any other medications or are under the care of a doctor you should consult the physician before using. IRISH MEDICINES BOARD _______________________ Lue koko asiakirja