Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID
Bayer PLC
300 Milligram
Tablets
1978-04-01
Irish Medicines Board ______________________________________________________________________________________________________________________ Date Issued 22/08/2005 CRN 2012521 page number: 1Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Bayer Aspirin 300 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 300 mg of Acetylsalicylic acid. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White tablet with the word 'Aspirin' and '0.3' on one surface and the Bayer cross on the other. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications For the symptomatic relief of headache, neuralgia, musculoskeletal aches, rheumatism, common cold, influenza and menstrual pain. 4.2 Posology and method of adminstration The usual dose in adults and children aged 12 and over is 600 to 900mg. The dose may be repeated at four hourly intervals if necessary.The daily maximum dose is 12 tablets (3.6g). Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk. 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. 4.3 Contraindications Aspirin should not be administered to patients: With a history of hypersensitivity reactions (e.g. bronchospasm, rhintis, urticaria) in response to asprin, other salicylates or substances with similar actions e.g. non-steroidal anti -inflammatory drugs. With known hypersensitivity to any of the other ingredients, refer to section 6.1. With active peptic ulceration or a history of peptic ulceration. With haemorrhagic diseases such as haemophilia. You are pregnant of breast -feeding. Receiving a dose of methrotrexate at 15mg/week or greater. Read the complete document