SKINOREN CREAM 20%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AZELAIC ACID

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

D10AX03

Dosage:

0.2 g/g

Pharmaceutical form:

CREAM

Composition:

AZELAIC ACID 20g/100g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LEO Pharma Manufacturing Italy S.r.I.

Authorization status:

ACTIVE

Authorization date:

1992-07-14

Patient Information leaflet

IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040
IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert
148 x 210 mm
IIT004-00
29/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90040
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040
IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert
148 x 210 mm
IIT004-00
29/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90040
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
Manufactured by:
LEO Pharma Manufacturing Italy S.r.I
Important information, please read carefully!
COMPOSITION
Skinoren contains a white, opaque cream. 1 g Skinoren cream contains
200 mg (20 %) azelaic acid.
For the full list of excipients, see section _List of excipients._
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: other anti-acne preparations for topical
use, ATC code: D10AX03
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 respi

Summary of Product characteristics

IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040
IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert
148 x 210 mm
IIT004-00
29/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90040
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
SKINOREN®
Anti-acne agent
Manufactured by:
LEO Pharma Manufacturing Italy S.r.I
Important information, please read carefully!
COMPOSITION
Skinoren contains a white, opaque cream. 1 g Skinoren cream
contains 200 mg (20 %) azelaic acid.
For the full list of excipients, see section List of excipients.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: other anti-acne preparations for
topical use, ATC code: D10AX03
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 percuta