CATAFLAM DROPS 1.5%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DICLOFENAC RESINATE EQV DICLOFENAC SODIUM

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

M01AB05

Dosage:

15 mg/ml

Pharmaceutical form:

SOLUTION

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Delpharm Huningue S.A.S.

Authorization date:

1994-01-24

Patient Information leaflet

CATAFLAM


Anti-inflammatory and anti-rheumatic product, non-steroid, acetic
acid derivative and related 
substance. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM  
Oral drops suspension. 
ACTIVE SUBSTANCE  
The
active substance is [o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate resinate
(= diclofenac 
resinate). 
One hundred millilitres of Cataflam
®
 suspension (oral drops) contain diclofenac resinate 
equivalent to 1.5 g diclofenac sodium (0.5 mg per drop or
15 mg per mL). 
ACTIVE MOIETY 
Diclofenac 
EXCIPIENTS 
Castor oil, hydrogenated; paraffin liquid; saccharin
sodium; copolymer of acrylic and 
methacrylic acid with divinylbenzene
and ethylvinylbenzene (Zerolite 236 SRC 48), washed; 
tutti-frutti flavour. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Treatment of: 
  Juvenile rheumatoid arthritis, 
  Post-traumatic and post-operative pain, inflammation,
and swelling, e.g. following dental 
or orthopedic surgery, 
  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. 
Novartis   Page 2
Country Specific Package Leaflet (Singapore) 10 Feb 2012 
Cataflam oral drops suspension 
DOSAGE AND ADMINISTRATION 
DOSAGE 
As a general recommendation, the dose should
be individually adjusted and the lowest 
effective dose given for the shortest possible duration. 
The oral drops should be swallowed. 
ADULTS 
Specific pharmaceutical forms (e.g. tablets, suppositories, solution
for injection) are available 
for use in adults. The initial daily dose is 100 to 150 mg.
In milder cases, 75 to 100 mg daily 
is usually sufficient. 
 The total daily dose should generally be divided into 2 to 3
separa