País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
DICLOFENAC POTASSIUM
Novartis Pharmaceuticals UK Ltd
50 Milligram
Powder for Oral Solution
2006-07-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cataflam Sachets 50 mg Powder for Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is potassium [o-(2,6-dichlorophenyl)-amino]-phenyl-acetate (diclofenac potassium) One sachet contains 50mg diclofenac potassium The sachet also contains 50 mg aspartame (E951) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution. White to light yellow powder for oral solution. 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). 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. 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 contents of the sachet should be dissolved with stirring in a glass of natural (non-carbonated) water. The solution may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be swallowed prefer Leer el documento completo