Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Stada Arzneimittel AG
50 Milligram
Tablets
2000-02-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac 50 mg Stada Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains diclofenac sodium 50 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. Light-brown circular, biconvex, gastro-resistant tablets, 8mm x 4.3mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diclofenac 50mg Stada Gastro-resistant Tablets are indicated for the relief of all grades of pain and inflammation in a range of conditions, including: 1. arthritic conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, psoriatic arthropathy. 2. acute musculo-skeletal disorders such as periarthritis (e.g. frozen shoulder), tendinitis, tenosynovitis, bursitis. 3. other painful conditions resulting from trauma including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. 4. the management of dysmenorrhoea and associated menorrhagia. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral use only. Adults: The recommended dose is 75-150 mg daily in two or three divided doses, taken whole with liquid. 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. The lower strength Diclofenac preparations may therefore be appropriate. Children: The recommended dose is 1-3 mg/kg daily in divided doses. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen. 4.3 CONTRAINDICATIONS Patients with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to Diclofenac, aspirin or nonsteroidal anti-inflammatory drugs. Patients with peptic ulceration, or gastro-intestinal Baca dokumen lengkap