DICLOFENAC 100 MG PROLONGED RELEASE TABLETS

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

DICLOFENAC SODIUM

Disponibbli minn:

Olinka (UK) Limited

Dożaġġ:

100 Milligram

Għamla farmaċewtika:

Tablets

Data ta 'l-awtorizzazzjoni:

1997-09-05

Karatteristiċi tal-prodott

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac 100 mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac Sodium 100 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White, circular, biconvex tablets, diameter 12.0 mm with a Greek
Delta symbol embossed on one side.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Relief of all grades of pain and inflammation in conditions such
as:
(i)
arthritic conditions: rheumatoid arthritis, ankylosing spondylitis,
acute gout, psoriatic arthropathy.
(ii)
acute musculo-skeletal disorders such
as periarthritis (for example frozen shoulder), tendinitis,
tenosynovitis, 
bursitis.
(iii)
other painful conditions resulting from trauma, including
fracture, low back pain, sprains, bruises, strains,
 dislocations, orthopaedic, dental and other minor surgery.
Dysmenorrhoea and associated menorrhagia.
For the symptomatic treatment of osteoarthritis.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Dosage
Route of administration: oral.
Adults: One tablet daily, taken whole with liquid, preferably
at meal times.
Elderly: NSAIDs should be used with particular caution in elderly
patients who are more prone to adverse events. The 
lowest effective dosage of diclofenac compatible with
adequate safe clinical control should be employed. (See also 
Special warning and precautions, Section 4.4).
Treatment should be reviewed at regular intervals and
discontinued if no benefit is seen or intolerance occurs.
Children: Not recommended.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 11/11/2005_
_CRN 2016774_
_page number: 1_
4.3 CONTRAINDICATIONS
Patients with active or suspected peptic ulceration,
peptic ulcer disease or gastro-intestinal bleeding.
Previous sensitivity to
diclofena