Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
DICLOFENAC POTASSIUM
Novartis Pharmaceuticals UK Ltd
DICLOFENAC POTASSIUM
25 Milligram
Coated Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cataflam 25mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg diclofenac potassium. Each tablet also contains 45mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated Tablet (Tablet). Circular, biconvex, pale red sugar coated tablet approximately 7.7mm diameter imprinted “CG” on one side and “DD” on the other. 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. ADULTS The total daily dose should generally be divided in 2 to 3 doses. In primary dysmenorrhoea, the daily dose should be individually Läs hela dokumentet