VOLTAREN EMULGEL 1%

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

DICLOFENAC DIETHYLAMMONIUM

Fáanlegur frá:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (Alþjóðlegt nafn):

DICLOFENAC DIETHYLAMMONIUM

Einingar í pakka:

50gm mcg/mL; 30gm mcg/mL; 20gm mcg/mL; 10 gm mcg/mL; 20 gm mcg/mL; 50 gm mcg/mL

Framleitt af:

NOVARTIS PHARMA PRODUKTIONS GMBH

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 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 medicines
used to treat pain, fever or
inflammation, such as ibuprofen or
acetylsalicylic acid (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
these medicines may include:
wheezing or

Vara einkenni

MY -SG 317951 – XXXXXX
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%) of diclofenac diethylamine,
which corresponds to 10 mg (1%) of diclofenac sodium.
3. PRODUCT DESCRIPTION
White to practic ally white, soft, homogeneous, cream -like gel.
4.PHARMACODYNAMICS
ATC code: M02A A15
Mechanism of action and pharmacodynamic effects:
Diclofenac is a non -steroidal anti -rheumatic drug (NSAR) with marked analgesic, anti -
inflammatory and antipyretic properties.
Voltaren Emulgel is an anti -inflammatory and analgesic preparation for external use.
The white cream, non -greasy Emulgel is easily rubbed into the skin and has, thanks to
the aqueous -alcoholic basis, a soothing, cooling effect. The demonstrated inhibition of
prostaglandin biosynthesis by diclofenac is considered as an important part of its
mechanism of action.
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, compare d 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 di clofenac diethylamine gel to hand and
knee joints.