CATAFLAM 50 TABLET 50 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

M01AB05

Dosage:

50 mg

Pharmaceutical form:

TABLET, SUGAR COATED

Composition:

DICLOFENAC POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Saglik, Gida ve Tarim Urunleri San. ve Tic. A.S.

Authorization status:

ACTIVE

Authorization date:

1991-04-08

Patient Information leaflet

CATAFLAM


Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related 
substance. 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM 
Sugar-coated tablets. 
ACTIVE SUBSTANCE 
The  active  substance  is  potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate  (= 
diclofenac potassium). In Cataflam the sodium ion of diclofenac sodium (Voltaren
®
) has been 
replaced by a potassium ion. 
One Cataflam sugar-coated tablet
contains 25 mg or 50 mg of diclofenac potassium.  
Certain dosage strengths may not be available
in all countries. 
ACTIVE MOIETY 
Diclofenac 
EXCIPIENTS 
CORE:  Magnesium  stearate;  povidone;  silica  colloidal  anhydrous;  sodium  starch  glycollate; 
maize starch; calcium phosphate. 
SUGAR-COAT: Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide (E172) and 
titanium dioxide (E171) (dispersed Anstead); povidone; talc;
sucrose. 
POLISH: polyethylene glycol 8000; sucrose. 
IMPRINT with printing ink brown for 25 mg and white for
50 mg. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Short-term treatment in the following acute conditions: 

  Post-traumatic pain, inflammation and swelling, e.g.
due to sprains. 

  Post-operative  pain,  inflammation  and  swelling,  e.g.  following  dental  or  orthopaedic 
surgery. 

  Painful  and/or  inflammatory  conditions  in  gynecology,  e.g.  primary  dysmenorrhoea  or 
adnexitis. 

  Migraine attacks. 

  Painful syndromes of the vertebral column. 
Novartis 

Page 2 
Country Specific Package Leaflet (Singapore)30 Sep 2013 
Cataflam tablets 


  Non-articular rheumatism. 

  As  an  adjuvant  in  severe  painful  inflammatory  infections  of  the  ear,  nose  or  throat,  e.g. 
pharyngotonsilliti

Summary of Product characteristics

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TRADE-NAME(S)
CATAFLAM

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative and related
substance.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Sugar-coated tablets.
ACTIVE SUBSTANCE
The active substance is diclofenac potassium. In Cataflam
®
the sodium ion of diclofenac
sodium (Voltaren
®
) has been replaced by a potassium ion.
One Cataflam sugar-coated tablet contains 25 mg or 50 mg of diclofenac
potassium.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
CORE:
Magnesium stearate; povidone; silica colloidal anhydrous; sodium
starch glycollate;
maize starch; calcium phosphate.
SUGAR-COAT:
Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide
(E172) and
titanium dioxide (E171) (dispersed Anstead); povidone; talc; sucrose.
POLISH:
polyethylene glycol 8000; sucrose.
IMPRINT
with printing ink brown for 25 mg and white for 50 mg.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Short-term treatment in the following acute conditions:
•
Post-traumatic pain, inflammation and swelling, e.g., due to sprains.
•
Post-operative pain, inflammation and swelling, e.g., following dental
or orthopaedic
surgery.
•
Painful and/or inflammatory conditions in gynecology, e.g., primary
dysmenorrhoea or
adnexitis.
•
Migraine attacks.
•
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.
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DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
As a general recommendation, the dose should be individually adjusted.
Adverse effects may
be minimized by using the lowest effective dose for the shortest
duration necessary to control
symptoms (see section WARNINGS AND PRECAUTIONS)