SKINOREN CREAM

Country: Malaysia

Language: English

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

Active ingredient:

Azelaic Acid

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

Azelaic Acid

Units in package:

30 gm

Manufactured by:

LEO PHARMA MANUFACTURING ITALY S.R.L

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SKINOREN® CREAM
Azelaic acid (200 mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What Skinoren® Cream is used for
2.
How Skinoren® Cream works
3.
Before you take Skinoren® Cream
4.
How to take Skinoren® Cream
5.
While
you
are
using
Skinoren®
Cream
6.
Side effects
7.
Storage and Disposal of Skinoren®
Cream
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
KEEP THIS LEAFLET
. You may need to read
it again.
WHAT SKINOREN® CREAM IS USED FOR
-
Skinoren is a skin cream used to
treat acne.
-
Do not use this medicine for any
other skin condition.
HOW SKINOREN® CREAM WORKS
-
Skinoren
attacks
bacteria
which
cause acne.
-
Skinoren also stops dead skin cells
buildup which will block the pores
of the skin to form pimples.
BEFORE YOU USE SKINOREN® CREAM
-
_When you must not use it _
Do not use Skinoren® Cream:
-
If you are allergic to azelaic
acid
or
any
of
the
other
ingredients of this medicine
(listed under “Ingredients”).
-
_Before you start to use it _
-
Talk
to
your
doctor
or
pharmacist
before
using
Skinoren if you have asthma.
-
_Taking other medicine _
-
Tell your doctor or pharmacist
if you are using, have recently
used
or
might
use
any other
medicines.
HOW TO USE SKINOREN® CREAM
-
First
thoroughly
wash
with
plain
water the whole area to be treated. If
the skin is greasy use a mild skin
cleanser. Dry the skin thoroughly
and apply Skinoren gently. Wash
your
hand
thoroughly
after
using
Skinoren.
-
_How much to use _
-
The amount of Skinoren you
should use will depend on the
size of the area to be treated:
o
As a guide, if the whole of
your face is affected, use 1
fingertip (approx. 0.5 g) of
cream each time you apply
Skinoren.
o
If you have acne on your
chest and back, as well as
your
face,
adjust
the
amount
of
cream
accordingly.
-
Always
use
this
medicine
exactly as your doctor has told
you. Check with your doctor or
pharmacist if you are not sure.
-
_When to use it _
-
Unless your doctor has told you
otherwise, start treatme

Summary of Product characteristics

IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036
IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert, 50 g
165 x 300 mm
IIT001-01
09/08/2018
JUG
28/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90036
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
Important information, please read carefully!
COMPOSITION
Skinoren contains a white, opaque cream. 1 g Skinoren cream contains
0.2 g (20 % w/w) micronized
azelaic acid.
PHARMACODYNAMIC PROPERTIES
The antimicrobial action and a direct influence on follicular
hyperkeratosis are assumed to be the basis
for the therapeutic efficacy of Skinoren in acne.
Clinically, a significant reduction of the colonization density of
Propionibacterium acnes and a significant
reduction of the fraction of free fatty acids in the skin surface
lipids is observed.
_In vitro_ and _in vivo_, azelaic acid inhibits the proliferation of
keratinocytes and normalizes the disturbed
terminal epidermal differentiation processes in acne. In the rabbit
ear model, azelaic acid accelerates
the comedolysis of tetradecane-induced comedones
Experimental results demonstrate that azelaic acid exerts a dose- and
time-dependent inhibitory effect
on the growth and viability of abnormal melanocytes.
The molecular mechanisms by which this is accomplished are not
entirely clarified.
Currently available data suggest that the main effects of azelaic acid
in the treatment of melasma are
brought about by an inhibition of the DNA synthesis and/or an
inhibition of the cellular respiration of
the abnormal melanocytes.
PHARMACOKINETICS PROPERTIES
Azelaic acid penetrates into all layers of human skin after topical
application of the cream.
Penetration is faster into damaged skin than into intact skin. A total
of 3.6 % of the dose applied is
absorbed percutaneously after a single topical application of 1 g
azelaic acid (5 g cream).
A portion of the azelaic acid absorbed through the skin is excreted in
unchanged form in the urine.
The remaining portion is