FINACEA 15% GEL

Active substance: AZELAIC ACID

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Package leaflet: Information for the user

Finacea® 15 % Gel
Azelaic acid

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.
What is in this leaflet
1. What Finacea is and what it is used for
2. What you need to know before you use Finacea
3. How to use Finacea
4. Possible side effects
5. How to store Finacea
6. Contents of the pack and other information
1. What Finacea is and what it is used for
Finacea 15 % Gel (Finacea) contains the active substance
azelaic acid and belongs to the group of anti-acne
preparation for external use (on the skin). Finacea is for
the relief of mild to moderate papulopustular acne of
the face and the treatment of papulopustular rosacea.
Papulopustular acne and rosacea are associated with
inflamed papules and pustules.
2. What you need to know before you use Finacea
Do not use Finacea
R if you are allergic (hypersensitive) to azelaic acid or any
of the other ingredients of Finacea (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Finacea.
Finacea is for external use on the skin only. Take care to
avoid contact with the eyes, mouth and other mucous
membranes (the thin skin around body openings). In the
event of an accidental contact, wash the eyes, mouth and/
or affected mucous membranes with large amounts of
water. You should consult a doctor or pharmacist if an eye
irritation persists.
Please wash your hands after each application of Finacea.
It is advisable to avoid alcoholic cleansers, tinctures and
astringents, abrasives and peeling agents when using
Finacea for treatment of rosacea.
Rarely, it has been reported that in some patients with
asthma who were treated with azelaic acid worsening of
asthma symptoms had occurred.

Children and adolescents
Safety and efficacy in the treatment of acne have been
studied in 12-18 years old adolescents (see section 3.
How to use Finacea). Finacea is not recommended for the
treatment of acne in children below the age of 12 due to a
lack of data on safety and efficacy.
Finacea is not recommended for the treatment of rosacea
in children below the age of 18 due to a lack of data on
safety and efficacy.
Other medicines and Finacea
It has not been studied whether Finacea affects or is
affected by other medicines. Do not apply other medicines
or treatments to your face at the same time as Finacea.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
There is limited experience from use of azelaic acid during
pregnancy. If you are pregnant or breast-feeding, your
doctor will decide whether you can use Finacea.
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
Finacea has no influence on the ability to drive and use
machines.
Finacea contains benzoic acid and propylene glycol
Benzoic acid is mildly irritating to the skin, eyes and
mucous membranes.
Propylene glycol may cause skin irritation.
3. How to use Finacea
Always use Finacea exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Finacea is intended for external use on the skin only.
R Before you apply Finacea, clean the skin thoroughly
with water and dry. You may use a mild skin-cleansing
agent.
R Do not use air- and water-tight (occlusive) dressings or
wrappings, and wash your hands after applying the
gel.
R Apply Finacea to the affected skin areas twice a day
(in the morning and in the evening) and rub it gently
into the skin. Approximately 2.5 cm, which is equal to
0.5 g (1 inch) of gel, is sufficient for the entire face.
Finacea works more effectively if used continuously over
the entire period of treatment.
In the event of an irritation of the skin (see section
4. Possible side effects), reduce the amount of gel per
application or the frequency of use of Finacea to once a day
until the irritation ceases. If necessary, you should interrupt
the treatment temporarily for a few days.
Use in children and adolescents
Dose adjustment in children aged 12-18 years treated for
acne is not necessary.
Duration of treatment
How long Finacea has to be used can vary from person to
person and also depends on the severity of the skin disorder.
Your doctor will tell you how long you should use
Finacea.
Acne: You can use Finacea over several months depending
on the effect of the treatment. In general, you may notice a
distinct improvement after 4 weeks.

In case of no improvement after 1 month or if the acne
becomes worse, you should discontinue Finacea and
consult your doctor.
Rosacea: You can use Finacea over several months
depending on the effect of the treatment. You may notice a
distinct improvement after 4 weeks of the treatment.
In case of no improvement after 2 months or if the rosacea
becomes worse, you should discontinue Finacea and
consult your doctor.
If you use more Finacea than you should
Even if you have accidentally used more Finacea than you
should, a harmful effect (intoxication) is unlikely.
Please continue as prescribed and ask your doctor if you
are not sure.
If you forget to use Finacea
Do not use twice the amount to make up for a forgotten
treatment. Continue as prescribed by your doctor.
If you stop using Finacea
If you stop using Finacea your skin disease can get worse.
Please ask your doctor before you stop using Finacea.
If you have any further questions on the use of Finacea, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Finacea can cause side effects, although
not everybody gets them. Skin irritations (for example
burning and itching) may occur.
In the majority of cases, the irritation symptoms are mild or
moderate and their frequency decreases during the course
of therapy.
The most frequently observed side effects included itching
(pruritis), burning and pain at the application site.
The following side effects may occur during the treatment
with Finacea Gel. They only concern the skin in the
application area:
Acne:
Very common (may affect more than 1 in 10 people):
Burning, pain, itching (pruritis) at the application site
Common (may affect up to 1 in 10 people): Rash, feeling
of tingling or numbness (paraesthesia), dry skin at the
application site
Uncommon (may affect up to 1 in 100 people): Skin
reaction due to an external agent (contact dermatitis),
abnormal redness of the skin (erythema); scaling, warmth,
skin discolouration at the application site
Rare (may affect up to 1 in 1,000 people): allergic
reaction (hypersensitivity), worsening of asthma
Rosacea:
Very common (may affect more than 1 in 10 people):
Burning, pain, itching (pruritus) at the application site
Common (may affect up to 1 in 10 people): Feeling
of tingling or numbness (paraesthesia), dry skin, rash,
swelling (oedema) at the application site
Uncommon (may affect up to 1 in 100 people): Acne,
skin reaction due to an external agent (contact dermatitis),
abnormal redness of the skin (erythema); nettle rash
(urticaria), discomfort at the application site
Rare (may affect up to 1 in 1,000 people): allergic
reaction (hypersensitivity), worsening of asthma

Children and adolescents
Treatment of acne vulgaris in adolescents 12-18 years of
age:
In clinical studies involving adolescents, the overall
incidence of adverse events for Finacea was similar to that
for the entire patient population.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
5. How to store Finacea
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the carton and tube after “EXP”. The expiry date
refers to the last day of that month.
Finacea does not require any special storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines no longer required. These measures will help
protect the environment.
6. Contents of the pack and other information
What Finacea contains
R The active substance is azelaic acid (Each gram of
Finacea contains 150 mg of azelaic acid).
R The other ingredients are lecithin, triglycerides
(medium chain), polysorbate 80, propylene glycol,
carbomer 980, sodium hydroxide, disodium edetate,
purified water and benzoic acid (E210).
What Finacea looks like and contents of the pack
Finacea is a white to yellowish-white opaque gel.
Finacea is available in pack sizes of 5, 30, 50 or 2 x 50 g of
gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Intendis GmbH
Max-Dohrn-Straße 10
D-10589 Berlin
Manufactured by:
Intendis Manufacturing S.p.A.
Via E. Schering 21
20090 Segrate (Milan)
Italy
The distributor in the UK is:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire, RG14 1JA, United Kingdom.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Finacea: Denmark, France, Iceland, Italy, Norway, Portugal,
Spain, Sweden, United Kingdom.
Skinoren 15% Gel: Austria, Finland, Germany, Greece,
Ireland, Luxembourg
This leaflet was last revised in 03/2013

Great Britain 81488274

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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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