DOSANAC EMULSION GEL

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

DICLOFENAC SODIUM

Fáanlegur frá:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Alþjóðlegt nafn):

DICLOFENAC SODIUM

Einingar í pakka:

25 gm

Framleitt af:

SIAM BHEASACH CO LTD

Upplýsingar fylgiseðill

_ _
_ _
_ _
_ Consumer Medication Information Leaflet (RiMUP)_
DOSANAC
® EMULSION GEL
Diclofenac Diethylammonium (1%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What DOSANAC is used
for
2.
How DOSANAC works
3.
Before you use DOSANAC
4.
How to use DOSANAC
5.
While you are using
DOSANAC
6.
Side effects
7.
Storage and Disposal of
DOSANAC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DOSANAC IS USED FOR
DOSANAC is a topical gel
used for the relief of pain and
inflammation affecting the
joints and muscles. It can be
used to treat:-

muscle, joints, tendons,
ligaments injuries

tendonitis or tennis elbow

mild arthritis of the knee or
fingers
HOW DOSANAC WORKS
DOSANAC belongs to a class
of medicines known as non-
steroidal anti-inflammatory
drug (NSAID) with analgesic,
anti-inflammatory and
antipyretic properties.
It works by inhibiting
prostaglandin synthesis to
relieve pain, reduce
inflammation and swelling of
the painful joints and muscles.
BEFORE YOU USE DOSANAC
_When you must not use it _
Do not use DOSANAC if you
are:

allergic to NSAID that used
to treat pain, fever and
inflammation, such as
aspirin or ibuprofen

allergic to diclofenac or any
other ingredients in this
medicine

in the last 3 months of
pregnancy
_Before you start to use it _
Tell your doctor or pharmacist
before using DOSANAC if
you are:

having skin conditions such
as cuts, open wounds, rash
or eczema

using other NSAID
medications

pregnant, especially during
the last 3 months of
pregnancy

breast-feeding or plan to
start breast-feeding
_Taking other medicines _
Tell your doctor or pharmacist
if you are taking or have
recently taken any medicines,
including traditional products
bought without a prescription.
HOW TO USE DOSANAC
_How much to use _
For topical application only.
Apply DOSANAC emulsion
gel 3 to 4 times daily on the
affected area.
Gentle massage on the area is
recommended to ensure drug
absorption into the skin. You
may notice a slight cooling
effect when you rub

Vara einkenni

Drawing No.
DOS-EMU-GEL-1-04-L-MY-A0005
Sent date 30/03/2020
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each 1 g contains 11.6 mg diclofenac diethylammonium, which
corresponds to 10 mg diclofenac sodium
(Preservative: 0.025%w/w sodium metabisulphite and 0.5%w/w benzyl
alcohol ; Solvent: 5%w/w
isopropyl alcohol)
PRODUCT DESCRIPTION
White to creamy white cream like gel
PHARMACODYNAMICS
Mechanism of action
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).
Diclofenac gel 1% is an anti-inflammatory and analgesic preparation
designed for topical application.
In inflammation and pain of traumatic or rheumatic origin, diclofenac
gel 1% relieves pain and decreases
swelling.
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 as well as the degree of
skin hydration.
Absorption amounts to about 6% of the applied dose of diclofenac after
topical application of 2.5 g
diclofenac gel 1% on 500 cm
2
skin, determined by total renal elimination, compared with diclofenac
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
diclofenac
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 serums, 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 the joint), rather than
in th