CATAFLAM TABLET 50MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

DICLOFENAC POTASSIUM

Units in package:

100Tablet Tablets; 500Tablet Tablets; 10 Tablet Tablets

Manufactured by:

NOVARTIS SAGLIK

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
CATAFLAM
® TABLET
_ _
Diclofenac Potassium (50mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT CATAFLAM TABLET IS
USED FOR
2.
HOW CATAFLAM TABLET WORKS
3.
BEFORE YOU USE CATAFLAM
TABLET
4.
HOW TO USE CATAFLAM TABLET
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
CATAFLAM TABLET
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT CATAFLAM IS USED FOR
The active substance in Cataflam
tablet is diclofenac potassium.
Cataflam belongs to a group of
medicines
called
“non-steroidal
anti-inflammatory
drugs”
(NSAIDs), which are used to treat
pain and inflammation.
Cataflam
can be used for short-term
treatment
of
the
following
conditions:
•
Sprains, strains, or other injuries.
•
Pain and swelling after surgery.
•
Painful inflammatory conditions
in gynecology, including painful
menstrual periods.
•
Back
pain,
frozen
shoulder,
tennis elbow, and other forms of
soft-tissue rheumatism.
•
As an adjuvant in severe painful
inflammatory infections of the
throat, nose or ears.
•
Migraine attacks.
Cataflam may also be used to treat
other conditions as determined by
your doctor.
HOW CATAFLAM WORKS
Cataflam relieves the symptoms of
inflammation,
such
as
pain
and
swelling, by blocking the synthesis
of the molecules (prostaglandins)
responsible for inflammation, pain
and fever. It has no effect on the
causes of inflammation or fever.
BEFORE YOU USE CATAFLAM
Follow
all
your
doctor’s
instructions
carefully.
They
may
differ from the general information
contained in this leaflet.
-
_When you must not use it _
•
If
you
are
allergic
(hypersensitive) to diclofenac
or
to
any
of
the
other
ingredients listed at the end of
this leaflet.
•
If you have ever had an allergic
reaction after taking medicines
to treat inflammation or pain
(e.g.
acetylsalicylic
acid,
diclofenac
or
ibuprofen).
Reactions may include asthma,
runny nose, skin rash, swelling
of the face, lips, tongue, throat,
and/or
extremities
(sig

Summary of Product characteristics

Novartis
Page 2
Malaysia Package Insert
08-Sep-2022
Cataflam tablets
CATAFLAM

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative.
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 50 mg of diclofenac
potassium.
DESCRIPTION
Reddish-brown round biconvex sugar-coated tablets.
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 white.
Pharmaceutical formulations may vary between countries.
INDICATIONS
As short-term treatment for the following acute conditions in cases
where particular importance
is attached to a prompt onset of effect (within 30 minutes):

Painful post-traumatic inflammatory states, e.g. due to sprains.

Post-operative inflammation and pain, e.g. following dental or
orthopaedic surgery.

Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or
adnexitis.

Acute migraine attacks. Cataflam should not be used for migraine
prophylaxis.

Painful syndromes of the vertebral column.

Non-articular rheumatism.
Novartis
Page 3
Malaysia Package Insert
08-Sep-2022
Cataflam tablets

As an adjuvant in severe painful inflammatory infections of the
throat, nose, or ears, 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.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
As a general recommendation, the dose should be individually adjusted.
Adverse effects may
be m