Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Norton Waterford
25 Milligram
Tablets
1992-11-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Sodium 25 mg Tablets Enteric Coated 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of diclofenac sodium. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.1.1 In the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders including periarthritis, tendinitis, tenosynovitis, bursitis, sprain, strains, dislocations and in acute gout. 4.1.2 In the management of post operative pain and inflammation in orthopaedic dislocations and in acute gout. 4.1.3 In the management of dysmenorrhoea and associated menorrhagia. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults: The usual daily dosage is 100mg in divided doses. This may be increased to 150mg daily. Children: The usual total daily dose is 1 – 3mg/kg daily in divided doses. Elderly: NSAIDs 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. 4.3 CONTRAINDICATIONS Use in asthmatic patients hypersensitive (e.g. bronchospasm, rhinitis, urticaria) to aspirin or other non-steroidal anti- inflammatory agents, including diclofenac. Use in patients with active or suspected peptic ulceration or peptic ulcer disease, or with gastrointestinal bleeding. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The product should only be used with great caution in patients with a history of peptic ulcer, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding di Lire le document complet