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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
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