Voltaren 12 Hours Emulgel 2% Gel

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC DIETHYLAMINE

Boleh didapati daripada:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

DICLOFENAC DIETHYLAMINE

Unit dalam pakej:

30 gm; 50 gm

Dikeluarkan oleh:

GSK Consumer Healthcare SARL

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VOLTAREN 12 HOURS EMULGEL 2% GEL
Diclofenac diethylamine (23.2mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What Voltaren 12 Hours Emulgel
2% Gel is used for
2.
How Voltaren 12 Hours Emulgel
2% Gel works
3.
Before
you
use
Voltaren
12
Hours Emulgel 2% Gel
4.
How to use Voltaren 12 Hours
Emulgel 2% Gel
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Voltaren
12 Hours Emulgel 2% Gel
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT VOLTAREN 12 HOURS EMULGEL 2%
GEL
IS USED FOR
Voltaren 12 Hours Emulgel 2% Gel 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 and joints injuries (e.g.
sprains,
strains,
bruises,
backache, sports injuries);
•
tendonitis
(e.g.
tennis
elbow),
swelling around elbow or knee;
•
mild
arthritis
of
the
knee
or
fingers.
Voltaren
12
Hours
Emulgel 2% Gel is intended for
use
in
adults
and
adolescents
aged 12 years and older.
HOW VOLTAREN 12 HOURS EMULGEL 2%
GEL WORKS
Voltaren 12 Hours Emulgel 2% Gel
contains
the
active
substance
diclofenac, which is a non-steroidal
anti-inflammatory drug (NSAID). It
is specially formulated for rubbing
into the skin.
BEFORE YOU USE VOLTAREN 12 HOURS
EMULGEL 2% GEL
-
_When you must not use it _
Do
not
use
Voltaren
12
Hours
Emulgel 2% Gel 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 this medicine. If
you are not sure, ask your doctor
or pharmacist. Symptoms of an
allergic
reaction
may
include:
wheezing or shortness of breath
(asthma); skin rash with blisters
or hives; swelling of the face or
tongue; runny nose.
•
you are in the last 3 months of
pregnancy.
_Important information about some of _
_the ingredients of Voltaren 12 Ho

Ciri produk

1. BRAND OR PRODUCT NAME
Voltaren 12 Hours Emulgel 2% Gel
2. NAME AND STRENGTH OF ACTIVE
SUBSTANCE
One gram of Voltaren 12 Hours Emulgel 2% Gel contains
23.2 mg (2.32% w/w) of diclofenac diethylamine, which
corresponds to 20 mg (2% 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 potent 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 12 Hours Emulgel 2% Gel is an anti-inflammatory
and analgesic preparation designed for topical application.
In inflammation and pain of traumatic or rheumatic origin,
Voltaren 12 Hours Emulgel 2% Gel 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.
After topical application of Voltaren 12 Hours Emulgel 2%
Gel (2 applications/day) to approximately 400 cm
2
of skin,
the extent of systemic exposure as determined by plasma
concentration of diclofenac was equivalent to diclofenac
diethylamine 1.16% gel (4 applications/day).
The relative bioavailability of diclofenac (AUC ratio) for
Voltaren 12 Hours Emulgel 2% Gel versus 50 mg diclofenac
sodium tablet was 4.5% on day 7 (for equivalent diclofenac
sodium dose). Absorption was not modified by a moisture
and vapour permeable bandage.
Voltaren 12 Hours Emulgel 2% Gel formulation contains a
permeation enhancer (0.75% oleyl alcohol). In an in vitro
skin barrier penetration study, this formulation was
compared to Voltaren Emulgel 1.16%, both applied at
20mg/cm
2
in a single dose. The findings demonstrated
approximately three times higher cumulative diclofenac skin
permeation for Voltaren