Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
PCO Manufacturing
75 Milligram
Capsules Modified Release
2006-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene 75mg Dual Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75mg diclofenac sodium in a modified release formulation (25 mg gastro-resistant pellets and 50mg prolonged release pellets). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified release capsule, hard. _Product imported from the UK:_ Size 2, hard gelatin capsules with light blue opaque caps and colourless transparent bodies, printed with "D75M" in white, containing white to cream-coloured spherical pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a non-steroidal anti-inflammatory analgesic in the symptomatic management of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, acute musculo-skeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations, relief of pain in fractures, low back pain, acute gout, psoriatic arthropathy. In the management of pain and inflammation associated with orthopaedic, dental and minor surgery. In the management of dysmenorrhoea and associated menorrhagia. 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). For oral use only. The capsules should be swallowed whole with liquid. _Adults: _One or two capsules (75-150 mg) in divided doses, daily. The daily dose should not exceed 150 mg. _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. _Children: _Not recommended. Treatment should be reviewed at regu Read the complete document