DIFFERIN GEL 0.1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ADAPALENE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

ADAPALENE

Dikeluarkan oleh:

LABS GALDERMA

Risalah maklumat

DIFFERIN
®
GEL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Adapalene 0.1% w/w
WHAT IS IN THIS LEAFLET
1.
What Differin
®
Gel is used for
2.
How Differin
®
Gel works
3.
Before you use Differin
®
Gel
4.
How to use Differin
®
Gel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Differin
®
Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIFFERIN® GEL IS USED FOR
Differin® Gel is a prescription medicine
for
use
on
skin
only
(topical)
for
treatment
of
acne
vulgaris
where
comedones,
papules
and
pustules
predominate. Acne of the face, chest or
back is appropriate for treatment.
HOW DIFFERIN
®
GEL WORKS
The active substance in Differin
®
Gel is
adapalene, which has anti-inflammatory
effects
that
reduces
the
inflammatory
components
of
acne
(papules
and
pustules) and normalizes the development
of skin cells, resulting in decreased acne
formation.
BEFORE YOU USE DIFFERIN
®
GEL
-
_When you must not use it _
_ _
If you are pregnant or planning a
pregnancy
If you are allergic to any ingredient of
the product.
If you have broken (cuts or abrasions),
irritated skin or severe acne.
_Pregnancy and lactation _
_ _
•
Do not use if you are pregnant or
thinking of becoming pregnant. Your
doctor can give you more information
•
Do not apply Differin
®
Gel on the
chest if you are breast-feeding. Ask
your doctor or pharmacist for advice
before taking any medicine.
-
_Before you start to use it _
_ _
Always
use
Differin
_® _
Gel
exactly
according
to
your
doctor’s
or
pharmacist’s advice. Check with them if
you are not sure.
-
_Taking other medicines _
_ _
Seek
advice
from
your
doctor
or
pharmacist
if
you
are
taking,
have
recently taken or might take any other
medicines
Concomitant
use
of
peeling
agents,
astringents
or
irritant
products
may
produce additive irritant effects.
Other
anti-acne
medicines
containing
erythromycin,
clindamycin
phosphate
or benzoyl peroxide may be used with
Differin
_® _
Gel, but they must be used in
the morning whil

Ciri produk

D I F F E R I N
®
a
d
a
p
a
l
e
n
e
G E L
NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
Product code: MOCK UP
Product description: DIFFERIN GEL
Market: MY
Article: Leaflet
Flat size: 180x315
Font size: 10 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
PMS 432U
PRODUCT INFORMATION
COMPOSITION
Differin Gel contains 0.1% w/w adapalene (BAN, INN, USAN), as the
active ingredient in a gel base containing carbomer, propylene glycol,
poloxamer 182, disodium edetate, methyl parahydroxybenzoate,
phenoxyethanol, sodium hydroxide to adjust the pH to 5 and purified
water to
complete the formulation.
PHARMACOLOGICAL PROPERTIES
Adapalene is a retinoid-like compound which, in _in vivo _and_ in
vitro_ models of inflammation, has been demonstrated to possess
anti-inflammatory
properties; Adapalene is essentially stable to oxygen and light and is
chemically non-reactive. Mechanistically, adapalene binds like
tretinoin to
specific retinoic acid nuclear receptors but, unlike tretinoin, not to
cytosolic receptor binding proteins.
Adapalene applied cutaneously is comedolytic in the rhino mouse model
and also has effects on the abnormal processes of epidermal
keratinization
and differentiation, both of which are present in the pathogenesis of
acne vulgaris. The mode of action of adapalene is suggested to be a
normalisation
of differentiation of follicular epithelial cells resulting in
decreased microcomedone formation.
Adapalene is superior to reference retinoids in standard
anti-inflammatory assays, both _in vivo _and_ in vitro_.
Mechanistically, it inhibits chemotactic and
chemokinetic responses of human polymorphonuclear leucocytes and also
the metabolism by lipoxidation of arachidonic acid to pro-inflammatory
mediators. This profile suggests that the cell mediated inflammatory
component of acne may be modified by adapalene. Studies in human
patients
provide clinical evidence that cutan