CATAFLAM 50 Milligram Coated Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

DICLOFENAC POTASSIUM

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

Code ATC:

M01AB05

DCI (Dénomination commune internationale):

DICLOFENAC POTASSIUM

Dosage:

50 Milligram

forme pharmaceutique:

Coated Tablets

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Acetic acid derivatives and related substances

Statut de autorisation:

Authorised

Date de l'autorisation:

1995-03-13

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cataflam 50mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg diclofenac potassium.
Each tablet also contains 67mg sucrose.
For a full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Coated tablet (Tablet)
Circular, biconvex, reddish brown sugar coated tablets approximately
8.8mm diameter.
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 minimised 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.
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