DIFNAL K TABLETS 50MG

Country: Malaysia

Language: English

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

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

DICLOFENAC POTASSIUM

Units in package:

10x10 Tablets; 100X10 Tablets; 10x10 Tablets; 10x10 Tablets

Manufactured by:

RANBAXY (MALAYSIA) SDN. BHD.

Patient Information leaflet

DIFNAL - K
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _ DICLOFENAC POTASSIUM TABLETS (50 MG)
Page 1 of 4
WHAT IS IN THIS LEAFLET
1.
What
DIFNAL – K
is used for
2.
How
DIFNAL – K
works
3.
Before you use
DIFNAL – K
4.
How to use
DIFNAL – K
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
DIFNAL –
K
8.
Product Description
9.
Manufacturer and Product
10.
Registration Holder
11.
Date of Revision
WHAT DIFNAL – K IS USED FOR
The active substance in
DIFNAL – K
tablet is diclofenac potassium.
DIFNAL – K
belongs to a group of
medicines
called
“non-steroidal
anti-
inflammatory drugs” (NSAIDs), which
are used to treat pain and inflammation.
DIFNAL – K
can be used for short-term
treatment of the following conditions:
•
Sprains, strains, or other injuries.
•
Pain and swelling after surgery.
•
Pain and swelling associated with
lady
problems
such
as
painful
menstrual
periods
or
infection
of
uterus and ovaries.
•
Migraine
attacks.
This
medicine
should
not
be
used
to
prevent
migraine attacks.
•
Painful
conditions
of
spine
like
spondylosis
•
Joint pain due to arthritis
•
Muscle and tendon pain such as back
pain, frozen shoulder, tennis elbow
etc.
•
As an adjuvant therapy in severe
painful inflammatory infections of
the throat, nose or ears.
HOW DIFNAL – K
WORKS
DIFNAL – K
relieves the symptoms of
inflammation, such as pain and swelling,
by
blocking
the
production
of
the
molecules
(prostaglandins)
responsible
for
inflammation
(swelling),
pain
and
fever. It has no effect on the causes of
inflammation or fever.
BEFORE YOU USE DIFNAL – K
Follow
all
the
doctor’s
instructions
carefully.
They
may
differ
from
the
general
information
contained
in
this
leaflet.
_ _
-
_When you must not use it _
Do not use
DIFNAL – K
if:
•
If you are allergic (hypersensitive) to
diclofenac
or
to
any
of
the
other
ingredients listed at the end of this
leaflet.
•
If you have a stomach or intestinal
ulcer,
perforation
or
bleeding
symptoms
of
which
may
include
blood in your stools or

Summary of Product characteristics

DIFNAL ‐ K
(DICLOFENAC POTASSIUM TABLETS 50 MG)
COMPOSITION
Each film coated tablets contains
Diclofenac Potassium
50 mg
PRODUCT DESCRIPTION
Brick red coloured, round, biconvex, coated tablets
DESCRIPTION
Diclofenac potassium is chemically designated as
2‐[(2,6‐dichlorophenyl)amino]benzeneacetic acid,
monopotassium salt. Its empirical formula is C

H

CI

NO

K and its molecular weight is 334.25
PHARMACOLOGY
MECHANISM OF ACTION
DIFNAL‐K contains potassium salt of diclofenac, a non‐steroidal
compound with pronounced
antirheumatic, analgesic, anti‐inflammatory and antipyretic
properties. Inhibition of prostaglandin
biosynthesis
is
considered
fundamental
to
its
mechanism
of
action.
Prostaglandins
play
an
important role in causing inflammation, pain and fever.
Diclofenac has a rapid onset of action which makes them particularly
suitable for the treatment of
acute painful and inflammatory conditions.
Diclofenac _ in vitro_ does not suppress proteoglycan biosynthesis in
cartilage at concentrations
equivalent to the concentrations reached in humans.
PHARMACODYNAMICS (PD)
Diclofenac has been reported to exert a pronounced analgesic effect in
moderate and severe pain.
In the presence of inflammation, e.g. due to trauma or following
surgical interventions, it rapidly
relieves both spontaneous pain and pain on movement and diminishes
inflammatory swelling and
wound edema.
In primary dysmenorrhea the active substance is capable of relieving
the pain and reducing the
extent of bleeding.
In migraine attacks diclofenac has been reported to be effective in
relieving the headache and in
improving the accompanying symptoms nausea and vomiting.
PHARMACOKINETICS
_Absorption _
Diclofenac
is
completely
absorbed
from
the
gastrointestinal
tract.
The
absorption
sets
in
immediately after administration and the same amount is absorbed as
from an equivalent dose of
diclofenac sodium gastro‐resistant tablets. Mean peak plasma
concentrations of 3.8 micro mol/L
are reported to be attained after 20 to 60 minutes