Skinoren

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Azelaic acid 20%

Available from:

LEO Pharma Limited

INN (International Name):

Azelaic acid 20%

Dosage:

20 %

Pharmaceutical form:

Topical cream

Composition:

Active: Azelaic acid 20% Excipient: Benzoic acid Cetearyl octanoate Glycerol Cutina CBS Polyethylene glycol 200 monostearate Propylene glycol Purified water

Units in package:

Tube, aluminium, 30 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Bayer AG

Therapeutic indications:

Topical treatment of acne vulgaris.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1989-06-13

Patient Information leaflet

Skinoren Cream
1
SKINOREN
 CREAM
AZELAIC ACID (A-ZEL-AE-IC ACID)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Skinoren Cream.
It does not contain all the available
information.
It does not take the place of talking
to your doctor (or pharmacist).
All
medicines
have
benefits
and
risks. Your doctor or pharmacist has
weighed
the
risks
of
you
using
Skinoren
Cream
against
the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
YOUR
MEDICINE. You may need to read it
again.
WHAT IS SKINOREN
CREAM USED FOR AND
HOW DOES IT WORK?
Skinoren Cream is used to treat the
following conditions:
Topical treatment of acne vulgaris,
usually simply called acne.
When
rubbed
into
the
skin,
the
azelaic acid in Skinoren Cream kills
the bacteria that
cause acne. In
addition, Skinoren Cream stops
the
acne-relevant (epidermal) skin cells
from growing too strongly and thus
blocking the pores of the skin to form
pimples.
There is no evidence that Skinoren
Cream is addictive.
BEFORE YOU USE
SKINOREN CREAM
_WHEN YOU MUST NOT USE IT _
DO NOT USE SKINOREN CREAM IF:

YOU
HAVE
AN
ALLERGY
TO:
Skinoren Cream or any of the
ingredients in Skinoren Cream
listed at the end of this leaflet, in
particular propylene glycol.
SKINOREN CREAM IS FOR EXTERNAL
USE ONLY.
You should be careful not to get
Skinoren Cream in your eyes when
putting it onto your face.
The absorption of Skinoren Cream
into the blood stream is very limited.
DO NOT USE SKINOREN CREAM JUST
BEFORE HAVING A BATH, SHOWER OR
GOING SWIMMING.
If
you
do,
you
may
reduce
the
effectiveness of Skinoren Cream.
_USING OTHER MEDICINES AND _
_SKIN TREATMENTS _
There is no information available on
the
use
of
Skinoren
Cream
in
conjunction with other skin disorder
treatments,
sunscreens
or
cosmetics.
DO NOT USE SKINOREN CREAM IF THE
PACKAGING IS TORN OR SHOWS SIGNS
OF TAMPERING.
DO NOT USE SKINOREN CREAM IF THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK HAS PASS

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 4
1 SKINOREN® 20% Cream
SKINOREN® 20% Azelaic Acid Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of white to slightly yellowish opaque cream contains 0.2 g (20%)
micronised azelaic acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical cream.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Topical treatment of acne vulgaris.
4.2
Dose and method of administration
Before SKINOREN® is applied, the skin should be thoroughly cleaned
with clear water or, if
applicable, a mild skin-cleansing agent.
SKINOREN® should be applied to the affected areas of skin twice a day
(morning and evening) and
rubbed gently into the skin. SKINOREN® should not be applied
sparingly; however, excessive
amounts of cream must be avoided (approximately 2.5 cm of cream is
sufficient for the entire facial
area).
In the event of excessive irritation of the skin, the amount of cream
per application should be
reduced or the frequency of use of SKINOREN® should be reduced to
once a day until the irritation
ceases. Treatment might have to be temporarily interrupted for a few
days.
It is important to continue to use SKINOREN® regularly over the
entire period of treatment.
The duration of use of SKINOREN® can vary from person to person and
also depends on the severity
of the skin disorder.
In acne, a distinct improvement becomes apparent after about 4 weeks.
To obtain the best results,
however, SKINOREN® should be used regularly over several months.
4.3
Contraindications
Hypersensitivity to the active substance, propylene glycol or any of
the other excipients listed in 6.1.
4.4
Special warnings and precautions for use
For external use only.
Local tolerance studies with the formulation in the rabbit eye showed
a moderate to high-grade
irritative effect; which is ascribed to the active substance. On
accidental contamination, the eye
should immediately be rinsed with copious amounts of water.
4.5
Interaction with other medicines and other forms of interaction
None so far know