国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID PARACETAMOL CAFFEINE
G & A Licensing Limited
ACETYLSALICYLIC ACID PARACETAMOL CAFFEINE
300/200/45 Milligram
Film Coated Tablet
Product not subject to medical prescription
Withdrawn
2013-04-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anadin Extra Film-coated Tablets Aspirin 300mg Paracetamol 200mg Caffeine 45mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: mg/tablet Acetylsalicylic Acid 300.0 mg Paracetamol 200.0 mg Caffeine 45.0 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablet (tablet). _Product imported from UK_ A Capsule shaped white tablet with a break bar on one side and with ‘A‘and ‘E’ debossed on the other side. The scoreline is to allow breaking for ease of swallowing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of pain of: Headache. Neuralgia. Myalgia. Rheumatism. Toothache. Dysmenorrhoea. Symptoms of the common cold or influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS OVER 16 YEARS: 1 - 2 tablets every 4 hours with a maximum of 6 in any 24 hour period. Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2011_ _CRN 2107054_ _page number: 1_ THE ELDERLY: Dosage is as above. Non-steroidal Anti-inflammatory Drugs 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. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredients or any other constituents. Patients with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to Anadin 阅读完整的文件