DICLOFENAC SODIUM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DICLOFENAC SODIUM
Available from:
Norton Waterford
Dosage:
25 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1992-11-27
Summary of Product characteristics
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
Read the complete document
