Differin Cream 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

Unit dalam pakej:

5gm mcg/mL; 30gm mcg/mL

Dikeluarkan oleh:

LABORATOIRES GALDERMA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIFFERIN
_® _
CREAM
Adapalene 0.1% w/w Cream
Page
1
of
2
WHAT IS IN THIS LEAFLET
1.
What Differin
_® _
Cream is used for
2.
How Differin
_® _
Cream works
3.
Before you use Differin
_® _
Cream
_4._
_ _
How to use Differin
_® _
Cream
_®_
_ _
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of Differin
_®_
_ _
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT DIFFERIN
_® _
CREAM IS USED FOR
Differin®
Cream
is
a
prescription
medicine
for
use
on
skin
only
(topical)
for
treatment
of
acne
vulgaris
where
comedones,
papules
and pustules predominate. Acne on the
face, chest or back is appropriate for
treatment.
HOW DIFFERIN
_® _
CREAM WORKS
The
active
substance
in
Differin
_® _
Cream is adapalene, which has anti-
inflammatory effects that reduces the
inflammatory
components
of
acne
(papules and pustules) and normalizes
development of skin cells, resulting in
decreased acne formation.
BEFORE YOU USE DIFFERIN
_® _
CREAM
_-_
_ _
_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
®
Cream 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
_® _
Cream 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 use any other
medicines
Concomitant
use
of
peeling
agents,
astringents
or
irritant
products
may
produce additive irritant effects.
Other anti-acne medicines contain

Ciri produk

D I F F E R I N
®
a
d
a
p
a
l
e
n
e
C R E A M
NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
Product code: MOCK UP
Product description: DIFFERIN CRE
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 10 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
PMS 432U
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
PRODUCT INFORMATION
COMPOSITION
Differin Cream contains 0.1% w/w adapalene (BAN, INN, USAN), as the
active ingredient in a cream base containing carbomer, PEG-20
methylglucose
sesquistearate,
glycerol,
natural
squalane,
methyl
parahydroxybenzoate,
propyl
parahydroxybenzoate,
disodium
edetate,
methylglucose
sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide to
adjust the pH to 6.5 ± 0.2 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
antiinflammatory
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