国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
DICLOFENAC POTASSIUM
Novartis Pharmaceuticals UK Ltd
M01AB05
DICLOFENAC POTASSIUM
50 Milligram
Coated Tablets
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances
Authorised
1995-03-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cataflam 50mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg diclofenac potassium. Each tablet also contains 67mg sucrose. For a full list of excipients, see section 6.1_._ 3 PHARMACEUTICAL FORM Coated tablet (Tablet) Circular, biconvex, reddish brown sugar coated tablets approximately 8.8mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of all grades of pain and inflammation in the following acute conditions: Post-traumatic pain, inflammation and swelling, e.g. due to sprains. Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis. Post operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and associated menorrhagia. Migraine attacks. Acute gout Painful syndromes of the vertebral column. Non-articular rheumatism. As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件