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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclo 50 mg Gastro-resistant Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of diclofenac sodium.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Tan, circular, biconvex, enteric-coated tablets, engraved ‘50’ over ‘0519’ on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diclofenac is indicated in the symptomatic management of rheumatoid arthritis (including juvenile chronic arthritis),
osteoarthrosis, ankylosing spondylitis, psoriatic arthropathy and low back pain; also for acute musculo-skeletal
disorders including periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations, and for the relief of
pain in fractures and acute gout.
Diclofenac is also indicated in the management of post operative pain and inflammation in orthopaedic, dental and
other minor surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults:_
75 - 150 mg daily in 2-3 divided doses. The tablets should be swallowed whole with liquid, preferably
before meal times.
_Children: _1 - 3 mg/kg per day in divided doses.
_Elderly_
Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in elderly
patients, non-steroidal anti-inflammatory drugs should be used with particular caution in such patients who
generally are more prone to adverse reactions. In particular, it is recommended that the lowest effective
dosage be used in frail elderly patients or those with a low body weight (_see section 4.4, Special warnings_
_and precautions for use_). If prolonged use is essential, the elderly must be kept under close surveillance.
Treatment should be reviewed at regular int
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