Package leaflet: Information for the patient

Azelaic acid

20 % Cream

Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
R If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Skinoren is and what it is used for
2. What you need to know before you use
Skinoren
3. How to use Skinoren
4. Possible side effects
5. How to store Skinoren
6. Contents of the pack and other 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
medicine 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. What you need to know before you use
Skinoren
Do not use Skinoren:
If you are allergic to azelaic acid or any of
the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
using 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.
Other medicines and Skinoren
Tell your doctor or pharmacist if you are
using, have recently used or might use any
other medicines.
Pregnancy and breast-feeding
There is limited experience with use of the
active substance azelaic acid during pregnancy.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Infants must not come into contact with
treated skin or breast.
Driving and using machines
Skinoren has no influence on the ability to
drive and use machines.
Skinoren contains benzoic acid
Benzoic acid is mildly irritating to the skin,
eyes and mucous membranes. Skinoren
contains a very small amount of this
ingredient.
Skinoren contains propylene glycol
Propylene glycol may cause skin irritation.
3. How to use Skinoren
Always use this medicine exactly as your
doctor has told you. 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.
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 medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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.
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 following side effects are based on reports
from clinical studies and post-marketing
surveillance with Skinoren Cream starting
with the most frequent ones:
Very common (may affect more than 1 in
10 people): burning, itching or abnormal
redness of the skin (erythema) at the site
of application.
Common (may affect up to 1 in 10 people):
scaling, pain, dryness, skin discolouration or
irritation at the site of
application.
Uncommon (may affect up to 1 in 100
people): greasy skin, acne or loss of skin
colour, tingling, dermatitis, discomfort
or swelling at the site of application.

Rare (may affect up to 1 in 1,000 people):
cracking of the lips, vesicles (small blisters),
eczema, ulceration, warmth at the site of
application, allergic reaction, rash at the site
of application.
Not Known (cannot be estimated from the
available data)1: skin swelling, eye swelling,
swelling face (which may occur with
hypersensitivity), rash, urticaria, worsening of
asthama.
1
These additional side effects have been
reported in patients using Skinoren Cream
(frequency unknown) since marketing approval.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Skinoren
R Keep this medicine out of the sight and
reach of children.
R Store Skinoren below 30°C.
R Do not use this medicine after the expiry
date which is stated on the box after EXP.
R After first opening of the container, the
in-use shelf life is 6 months.
R Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and other
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: Benzoic acid (E 210),
Cetearyl octanoate, Glycerol 85%, Glyceryl
stearate + cetearyl alcohol + cetyl palmitate +
cocoglycerides (CUTINA CBS), Propylene glycol,
Purified water, Stearoyl macrogolglycerides.
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,
BerkshireRG14 1JA,UK.
Manufacturer
Bayer HealthCare Manufacturing S.r.l.
Via E. Schering 21, 20090 Segrate (Milan),Italy
This leaflet was last revised in
September 2016.
Great Britain84791342