Voltaren Emulgel 1%

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

DICLOFENAC DIETHYLAMINE

Fáanlegur frá:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (Alþjóðlegt nafn):

DICLOFENAC DIETHYLAMINE

Einingar í pakka:

30 gm; 20 gm; 50 gm; 10 gm; 20 gm; 50 gm

Framleitt af:

GSK Consumer Healthcare SARL

Upplýsingar fylgiseðill

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
VOLTAREN EMULGEL 1%
Diclofenac diethylamine (11.6mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What
Voltaren
Emulgel
1%
is
used for
2.
How Voltaren Emulgel 1% works
3.
Before
you
use
Voltaren
Emulgel 1%
4.
How to use Voltaren Emulgel 1%
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Voltaren Emulgel 1%
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of Revision
WHAT VOLTAREN EMULGEL 1% IS USED FOR
Voltaren Emulgel 1% contains the active
substance diclofenac which belongs to a
group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). It is
specially formulated for rubbing into the
skin. Voltaren Emulgel 1% is used to
relieve
pain
and reduce
inflammation
and
swelling
in
a
number of
painful
conditions
affecting
the
joints
and
muscles. It can be used to treat:
•
Muscle, joints, tendons, ligaments
injuries
(e.g.
sprains,
strains,
bruises, backache, sports injuries);
•
tendonitis (e.g. tennis elbow);
•
mild arthritis of the knee or fingers.
HOW VOLTAREN EMULGEL 1% WORKS
Diclofenac
is
a
non-steroidal
anti-
inflammatory
drug
(NSAID)
with
pronounced
analgesic,
anti-
inflammatory and antipyretic properties.
Inhibition of prostaglandin synthesis is
the
primary
mechanism
of
action
of
diclofenac. Voltaren Emulgel 1% is an
anti-
inflammatory
and
analgesic
preparation
designed
for
topical
application in inflammation and pain of
traumatic or rheumatic origin. Voltaren
Emulgel 1% relieves pain and decreases
swelling.
BEFORE YOU USE VOLTAREN EMULGEL 1%
-
_When _
_you _
_must _
_not _
_use _
_Voltaren _
_Emulgel 1% _
•
If you are allergic (hypersensitive)
to diclofenac or other non-steroidal
anti-inflammatory medicines used
to treat pain, fever or inflammation,
such
as
ibuprofen or
aspirin
(a
substance
also
used
to
prevent
blood clotting), or any of the other
ingredients of Voltaren Emulgel
1% listed at the end of this leaflet.
If you are not sure, ask your doctor
or
pharmacist.
Symptoms
of
an
allergic reaction to thes

Vara einkenni

1. BRAND OR PRODUCT NAME
Voltaren Emulgel 1%
2. NAME AND STRENGTH OF ACTIVE
SUBSTANCE(S)
One gram of Voltaren Emulgel 1% contains 11.6 mg
(1.16% w/w) of diclofenac diethylamine, which
corresponds to 10 mg (1% w/w) of diclofenac sodium.
3. PRODUCT DESCRIPTION
White to practically white, soft, homogeneous, cream-like
gel.
4. PHARMACODYNAMICS
ATC CODE
M02AA15
MECHANISM OF ACTION AND PHARMACODYNAMIC EFFECTS
Diclofenac is a non-steroidal anti-inflammatory drug
(NSAID) with effective analgesic, anti-inflammatory and
antipyretic properties. Diclofenac exerts its therapeutic
effects primarily through inhibition of prostaglandin
synthesis by cyclo-oxygenase 2 (COX-2).
Voltaren Emulgel 1% is an anti-inflammatory and
analgesic preparation designed for topical application.
In inflammation and pain of traumatic or rheumatic origin,
Voltaren Emulgel 1% relieves pain and decreases swelling.
5. PHARMACOKINETICS
ABSORPTION
The quantity of diclofenac absorbed through the skin is
proportional to the size of the treated area, and depends
on both the total dose applied and the degree of skin
hydration.
Absorption amounts to about 6% of the applied dose
of diclofenac after topical application of 2.5 g Voltaren
Emulgel 1% on 500 cm² skin, determined by total renal
elimination, compared with Voltaren tablets. A 10-hour
occlusion leads to a three-fold increase in the amount
of diclofenac absorbed.
DISTRIBUTION
Diclofenac concentrations have been measured from
plasma, synovial tissue and synovial fluid after topical
administration of a diclofenac diethylamine gel to hand
and knee joints. Maximum plasma concentrations are
approximately 100 times lower than after oral
administration of the same quantity of diclofenac. 99.7%
of diclofenac is bound to serum proteins, mainly albumin
(99.4%).
Diclofenac accumulates in the skin which acts as reservoir
from where there is a sustained release of drug into
underlying tissues. From the skin and underlying tissue,
diclofenac preferentially distributes and persists in deep
inflamed tissues (such as t