SKINOREN 20% CREAM

Active substance: AZELAIC ACID

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PATIENT INFORMATION LEAFLET

Skinoren® 20% Cream
Azelaic acid

Read all of this leaflet carefully before
you start using this medicine.
R Keep this leaflet. You may need to read
it again.
R If you have any further questions, ask
your doctor or pharmacist.
R This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
R If you experience any side effect and
this becomes serious, tell your doctor or
pharmacist.
In this leaflet:
1. What Skinoren is and what it is used
for
2. Before you use Skinoren
3. How to use Skinoren
4. Possible side effects
5. How to store Skinoren
6. Further information
1. What Skinoren is and what it is used
for
R Skinoren is a skin cream used to treat
common acne (acne vulgaris).
R Skinoren Cream should only be used
to treat acne. You should not use this
product for any other skin condition.
R Skinoren attacks the bacterium called
Propionibacterium acnes, which plays an
essential part in causing acne. Skinoren
also reduces growth of the harder
outermost skin cells that block the pores
of the skin to cause blackheads and
whiteheads.
2. Before you use Skinoren
Do not use Skinoren:
If you are allergic (hypersensitive) to azelaic
acid, propylene glycol or any of the other
ingredients of Skinoren Cream. These are
listed in section 6, “Further Information”.
Take special care with Skinoren
Skinoren is for external use on the skin only.
You should not allow Skinoren to come
into contact with your eyes, mouth or other
mucous membranes. If it does, wash the
eyes, mouth or other mucous membranes
immediately with large amounts of cool
water.

Rarely, it has been reported that in some
patients with asthma who were treated with
azelaic acid worsening of asthma symptoms
had occurred.
Skinoren is not recommended for use in
children below the age of 12 due to a lack of
data on safety and efficacy.
Taking other medicines
Please tell your doctor or pharmacist if you
are using or have recently used any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
There is limited experience with use of the
active substance azelaic acid during
pregnancy. If you are pregnant or
breastfeeding, your doctor will decide
whether you can still use Skinoren.
Infants must not come into contact with
treated skin or breast.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and Using Machines
Skinoren has no influence on the ability to
drive and use machines.
Important information about some of the
ingredients of Skinoren
Benzoic acid: is mildly irritating to the skin,
eyes and mucous membranes. Skinoren
contains a very small amount of this
ingredient.
Propylene glycol: may cause skin irritation.
3. How to use Skinoren
Always use Skinoren exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Adults and Adolescents (12 - 18 years of age)
R 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 before applying Skinoren.
R Unless your doctor has told you
otherwise, start treatment with
Skinoren twice a day.
R If your skin is very sensitive use
Skinoren once a day, in the evening
during the first week of treatment.
Then change to twice a day.
R The amount of Skinoren you should use
will depend on the size of the area to
be treated:
P As a guide, if the whole of your face is
affected, use 2.5 cm (approx. 0.5 g) of
cream each time you apply Skinoren.

Bayer HealthCare Manufacturing s.r.l. (Segrate)
PZ
(technical drawing):
Laetus-code n°:
Bar-code n°:

Item n°:

2584A-4

Artwork date: 25/10/2013
Version n°: 01
Page: 1/2
Replaces: 81563810

82220224
Client:

215

Name:

044
Country:

Skinoren cream

Great Britain

Black

Recto - Corpo 10

Approved:

Date:

cod 134713

Colors:

P If you have acne on your chest and
back, as well as your face, adjust the
amount of cream accordingly.
Use the cream regularly. Rub it in gently.
Wash your hands thoroughly after using
Skinoren.
How long Skinoren has to be used varies
from person to person. It depends upon how
bad your acne is when you start treatment.
You should see a distinct improvement
after about 4 weeks. To get the best effect
you will probably have to use Skinoren
regularly for several months. However, you
should not use Skinoren for more than
12 months at any time.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Reasons to stop using Skinoren
Stop using Skinoren and see your doctor as
soon as possible if you think you are having
an allergic reaction (e.g. rash) to Skinoren.
Like all medicines, Skinoren can cause side
effects, although not everybody gets them.
Occasionally local skin irritation occurs with
Skinoren, usually at the start of
treatment. In most cases the irritation is
mild and usually gets better as treatment
continues. If skin irritation remains
troublesome:
R reduce the amount of Skinoren you apply
each time
R or apply it only once a day
R or stop treatment temporarily.
If skin irritation still remains troublesome
tell your doctor.
The reported side effects are listed below,
based on the following frequency scheme:
Very common: affects more than 1 user in 10.
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Very rare: affects less than 1 user in 10,000.
Not known: frequency cannot be estimated
from the available data.
Very common: burning, itching or abnormal
redness of the skin (erythema) at the site
of application.
Common: scaling, pain, dryness, skin
discolouration or irritation at the site of
application.
Uncommon: greasy skin, acne or loss of skin
colour, tingling, dermatitis, discomfort
or swelling at the site of application.
Rare: cracking of the lips, vesicles (small
blisters), eczema, ulceration, warmth at the
site of application, allergic reaction, rash at

the site of application, worsening of asthma
symptoms.
If you experience any of these side effects
and this becomes serious, or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store Skinoren
R Store Skinoren Cream out of the reach
and sight of children.
R Store Skinoren below 30°C.
R Do not use Skinoren after the expiry date
which is printed on the box.
R Medicines must not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. Further information
What Skinoren contains
R The active substance is azelaic acid. One
gram of Skinoren Cream contains 200 mg
(20% w/w) of azelaic acid.
R The other ingredients are: Arlatone 983S
(polyoxyethylene fatty acid ester), cutina
CBS (mixture of mono-diglycerides, fatty
alcohols, triglycerides and wax esters),
cetearyl octanoate, propylene glycol,
glycerol 85% (E422), benzoic acid (E210),
purified water.
What Skinoren looks like and contents of
the pack
Skinoren is a white opaque cream. Skinoren
is available in tubes containing 20, 30 or
50 g. Not all pack sizes are marketed.
Marketing Authorisation Holder
Bayer plc,
Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA, UK.
Manufacturer
Bayer HealthCare Manufacturing s.r.l.
Via E. Schering 21
20090 Segrate (Milan)
Italy
This leaflet was last revised in January
2014

Great Britain 82220224

Bayer HealthCare Manufacturing s.r.l. (Segrate)
PZ
(technical drawing):
Laetus-code n°:
Bar-code n°:

Item n°:

2584A-4

Artwork date: 25/10/2013
Version n°: 01
Page:
2/2
Replaces: 81563810

82220224
Client:

215

Name:

044
Country:

Skinoren cream

Great Britain

Black

Verso - Corpo 10

Approved:

Date:

cod 134713

Colors:

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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