CATAFLAM Coated Tablets 25 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

Novartis Pharmaceuticals UK Ltd

Dosage:

25 Milligram

Pharmaceutical form:

Coated Tablets

Authorization date:

1995-03-13

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cataflam 25mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg diclofenac potassium.
Each tablet also contains 45mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet (Tablet).
Circular, biconvex, pale red sugar coated tablet approximately 7.7mm diameter imprinted “CG” on one side and “DD”
on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of all grades of pain and inflammation in the following acute conditions:
○
Post traumatic pain, inflammation and swelling, e.g. due to sprains.
○
Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis,
bursitis.
○
Post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery.
○
Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and associated
menorrhagia.
○
Migraine attacks.
○
Acute gout.
○
Painful syndromes of the vertebral column.
○
Non-articular rheumatism.
○
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis.
In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as
appropriate. Fever alone is not an indication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control
symptoms _(see section 4.4)._
The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
_Adults:_
The total daily dose should generally be divided in 2 to 3 doses.
In primary dysmenorrhoea, the
                                
                                Read the complete document