DIFACLEAR GEL 0.1% W/W

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ADAPALENE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ADAPALENE

Unit dalam pakej:

1x15gm0 gm

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

DIFACLEAR
Page 1
DIFACLEAR
_Consumer Medication Information Leaflet (RiMUP)_
ADAPALENE GEL 0.1% W/W
WHAT IS IN THIS LEAFLET
1. What
DIFACLEAR
is used for
2. How
DIFACLEAR
works
3. Before you use
DIFACLEAR
4. How to use
DIFACLEAR
5. While you are using
DIFACLEAR
6. Side effects
7. Storage and Disposal of
DIFACLEAR
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT DIFACLEAR IS USED FOR
DIFACLEAR
contains
the
active
substance adapalene.
DIFACLEAR
is used for the treatment
of acne (blackheads, white heads and
pimples) on the face, chest or back.
HOW DIFACLEAR WORKS
DIFACLEAR
acts
against
the
abnormal skin processes associated
with acne. It has an anti-inflammatory
effect
that
reduces
soreness
and
irritation.
BEFORE YOU USE DIFACLEAR
_WHEN YOU MUST NOT USE IT_
Do not use
DIFACLEAR
if you are
allergic (hypersensitive) to adapalene
or any of the other ingredients of this
medicine
(see
section
PRODUCT
DESCRIPTION
).
If you are not sure whether you should
start using
DIFACLEAR
, talk to your
doctor or pharmacist.
Do not use this medicine after the
expiry date printed on the pack or if the
packaging
is
torn
or
shows
signs
of
tampering.
The expiry date refers to the last day of
that month.
If it has expired or is damaged, return it
to your pharmacist for disposal.
_BEFORE YOU START TO USE IT_
Talk to your doctor or pharmacist
before using
DIFACLEAR
if you:
•
have cuts, scrapes or if you have a
skin condition called eczema
•
have sunburned skin
•
have severe acne involving large
areas of the body
•
have inherent sensitivity to sun
Adapalene should not be used during
pregnancy.
If
you
become
pregnant
while
using
adapalene,
the
treatment
must be discontinued and you should
inform your doctor as soon as possible
for a further follow-up.
Adapalene can be used during breast-
feeding. To avoid contact exposure of
the infant, application of adapalene to
the chest should be avoided.
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby,

Ciri produk

1
_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
DIFACLEAR GEL 0.1% W/W
(ADAPALENE GEL)
COMPOSITION
ADAPALENE PH EUR.....................0.1 % W/W
PRESERVATIVE:
METHYL HYDROXYBENZOATE BP.......0.1 % W/W
IN AN AQUEOUS GEL BASE…………..QS
PRODUCT DESCRIPTION
DIFACLEAR GEL is white to off white viscous gel filled in aluminum
based laminated tube
DIFACLEAR GEL containing adapalene, is used for the topical treatment
of acne vulgaris. The
chemical
name
of
adapalene
is
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic
acid.
The
molecular formula is C
28
H
28
O
3
and molecular weight is 412.52. Adapalene is represented by the
following structural formula: STRUCTURAL FORMULA ADAPALENE
2
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
MECHANISM OF ACTION

PHARMACODYNAMICS
Adapalene
is
a
retinoid-like
compound
which
reported
to
possess
anti-inflammatory
properties.
Adapalene is essentially stable to oxygen and light and is chemically
non-reactive. Mechanically,
adapalene binds like tretinoin to specific retinoic acid nuclear
receptors but, unlike tretinoin not to
cytosolic receptor binding proteins.
It has been reported that adapalene applied cutaneously is comedolytic
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 reported to be superior to reference retinoids in
standard anti-inflammatory assays.
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.

PHARMACOKINETICS
Topical bioavailability is low. Biliary route is major route of
excretion. The elimin