DICLOFENAC SODIUM

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

DICLOFENAC SODIUM

Commercializzato da:

Norton Waterford

Dosaggio:

50 Milligram

Forma farmaceutica:

Tablets

Data dell'autorizzazione:

1992-11-27

Scheda tecnica

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium 50 mg Tablets Enteric Coated
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 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 dia