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FINACEA 15% GEL

Active substance(s): AZELAIC ACID / AZELAIC ACID / 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. See section 4.
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 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 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.

PZ
(technical drawing):
Laetus-code n°:
Bar-code n°:
Name:

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.
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.
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 this medicine 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.

Item n°:

84790958

2505A-4
272
Finacea gel

Client:
Country:

044
Great Britain

Colors:

Black
Approved:

Recto - Corpo 8

Replaces: 82195807

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) 1:
R Hypersensitivity, which may occur with one or more of the
following adverse reactions: Angioedema (rapid swelling
under the skin), Eye swelling, Swelling face, Dyspnoea
(shortness of breath)
R Skin irritation
R Urticaria (hives)
R Worsening of asthma
1
These side effects have been reported in patients using azelaic
acid since marketing approval.
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

PZ
(technical drawing):
Laetus-code n°:
Bar-code n°:
Name:

Rare (may affect up to 1 in 1,000 people) 1:
R Hypersensitivity, which may occur with one or more of the
following adverse reactions: Angioedema (rapid swelling
under the skin), Eye swelling, Swelling face, Dyspnoea
(shortness of breath)
R Skin irritation
R Urticaria (hives)
R Worsening of asthma
1
These side effects have been reported in patients using azelaic
acid since marketing approval.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 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: Benzoic acid (E210), carbomers,
disodium edetate, lecithin, polysorbate 80, propylene
glycol, sodium hydroxide and triglycerides medium chain.
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
Bayer plc,
Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA, UK.
Manufactured by:
Bayer HealthCare Manufacturing s.r.l.
Via E. Schering 21, 20090 Segrate (Milan), Italy
This medicinal product is authorised in the Member States
of the EEA under the following names:
Finacea: Denmark, France, Iceland, Italy, Norway, Spain,
Sweden, United Kingdom.
Skinoren: Austria, Finland, Germany, Greece, Ireland, Portugal
This leaflet was last revised in 09/2016

Great Britain 84790958

Item n°:

84790958

2505A-4
272
Finacea gel

Client:
Country:

044
Great Britain

Colors:

Black
Approved:

Verso - Corpo 8

Replaces: 82195807

Expand Transcript

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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