CATAFLAM 1.5% DROPS

Country: Malaysia

Language: English

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

Active ingredient:

DICLOFENAC SODIUM

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

DICLOFENAC SODIUM

Units in package:

15ml mL

Manufactured by:

Delpharm Huningue S.A.S.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CATAFLAM
®
1.5% DROPS
Diclofenac Resinate (15 mg/mL)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Cataflam Drops is used for
2.
How Cataflam Drops works
3.
Before you use Cataflam Drops
4.
How to use Cataflam Drops
5.
While you are using Cataflam
Drops
6.
Side Effects
7.
Storage and Disposal of
Cataflam Drops
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CATAFLAM IS USED FOR
The active substance in Cataflam oral
drops suspension is diclofenac
resinate that is used to treat pain and
inflammation.
Cataflam oral drops can be used for
short-term treatment of the following
conditions in children aged 1 year or
over:

Pain and swelling after surgery.

Infections of the ear, nose or
throat.
Cataflam oral drops are intended
primarily for use in children, but
doctors may decide to prescribe them
in certain cases for adults.
HOW CATAFLAM WORKS
Cataflam belongs to a group of
medicines called “non-steroidal anti-
inflammatory drugs” (NSAIDs) that
relieves the symptoms of
inflammation, such as pain and
swelling, by blocking the synthesis of
the molecules (prostaglandins). It has
no effect on the causes of
inflammation or fever.
BEFORE YOU USE CATAFLAM
Follow all the 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 extremeties
(signs of angioedema). If you
think you may be allergic, ask
your doctor for advice.

If you have a stomach or
intestinal ulcer.

If you have gastrointestinal
bleeding or perforation,
symptoms of which may include
blood in your stools

Summary of Product characteristics

Novartis
Page 2
Malaysia Package Leaflet
04-Aug-2021
Cataflam
®
Oral drops suspension
CATAFLAM

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Oral drops suspension.
ACTIVE SUBSTANCE
The active substance is diclofenac resinate.
Diclofenac is bound on resinate as an ion exchanger. Resinate is a
basic ion exchanger
consisting of polymers of styrol and approx. 2% divinylbenzene with
groups of quaternary
ammonium included in the net structure.
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).
DESCRIPTION
White to pale beige homogeneous oily suspension with a fruity odour.
ACTIVE MOIETY
Diclofenac
EXCIPIENTS
Castor oil, hydrogenated powder; paraffin liquid; saccharin sodium;
copolymer of acrylic and
methacrylic acid with divinylbenzene and ethylvinylbenzene (Zerolite
236 SRC 48), washed;
tutti-frutti flavour.
INDICATIONS
Short-term treatment in the following acute conditions:

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 3
Malaysia Package Leaflet
04-Aug-2021
Cataflam
®
Oral drops suspension
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).
GENERAL TARGET POPULATION: 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 di