FINACEA 15% Гель

Содержание инструкции

1. Finacea 15% Gel
   1. What you need to know before using Finacea Gel
   2. How to use Finacea Gel
   3. Possible side effects
   4. How to store Finacea Gel
   5. Contents of the pack and other information

Finacea 15% Gel

Azelaic acid

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:

1. What Finacea Gel is and what it is used for

2. What you need to know before you use Finacea Gel

3. How to use Finacea Gel

4. Possible side effects

5. How to store Finacea Gel

6. Contents of the pack and other information

1. What Finacea Gel is and what it is used for

Finacea Gel contains the active ingredient azelaic acid and belongs to the category of topical (cutaneous) anti-acne
preparations. Finacea Gel is indicated for the relief of mild to moderate grade papulopustular acne on the
face and for the treatment of papulopustular rosacea. Acne and papulopustular rosacea are associated with
the presence of papules and pustules of an inflammatory nature.

2. What you need to know before using Finacea Gel

Do not use Finacea Gel

• If you are allergic to azelaic acid or any of the excipients of this medicine (listed in section 6.).

Warnings and precautions
Talk to your doctor or pharmacist before using Finacea Gel.
Finacea Gel is for external (cutaneous) use only. Carefully avoid contact with eyes,
mouth and other mucous membranes. If accidental contact occurs, wash eyes,
mouth and/or affected mucous membranes with plenty of water. If eye irritation persists, consult a doctor or
pharmacist.
Always wash your hands after each application of Finacea Gel.
It is advisable to avoid the use of alcohol-based cleansers, tinctures and astringent products, products with
abrasive or exfoliating action (peeling) when Finacea Gel is used for the treatment of rosacea.
Rarely, a worsening of asthma symptoms has been reported in some patients who have been
treated with azelaic acid.

Children and adolescents
Safety and efficacy in the treatment of acne have been studied in adolescents between 12 and 18
years of age (see section 3. How to use Finacea Gel). Due to lack of safety and efficacy data, the use of Finacea Gel is not recommended for the treatment of acne in
children under 12 years of age.
Due to lack of safety and efficacy data, the use of Finacea Gel is not
recommended for the treatment of rosacea in children and adolescents under 18 years of age.

Other medicines and Finacea Gel
Studies to establish any interaction of Finacea Gel with other medicines
have not been conducted, and vice versa. Other medicines or treatments should not be applied to the face in conjunction with the use of
Finacea Gel.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Pregnancy and breastfeeding
Experience related to the use of azelaic acid during pregnancy is limited. If you are pregnant or
breastfeeding, your doctor will decide whether you can use Finacea Gel.
Newborns should not come into contact with skin or breasts treated with the product.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Finacea Gel does not affect the ability to drive vehicles or use machinery.

Finacea Gel contains benzoic acid and propylene glycol
Benzoic acid is slightly irritating to the skin, eyes and mucous membranes.
Propylene glycol may cause skin irritation.

3. How to use Finacea Gel

Always use this medicine exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist.
Finacea Gel is for external (cutaneous) use only.

Method of administration
Before applying Finacea Gel, thoroughly cleanse the skin with water and dry it.
You can use a mild skin cleanser.
Do not use airtight or waterproof (occlusive) clothing or bandages and wash your hands after
applying the gel.

Dosage and frequency of administration
Apply a small amount of Finacea Gel to the skin area to be treated, twice a day (morning and
evening), gently massaging it in. The amount of product sufficient for the entire
face is approximately 2.5 cm, which corresponds to 0.5 g of gel.
To achieve an optimal effect of the treatment, it is important to use Finacea Gel continuously for
the entire duration of therapy.
In case of skin irritation (see section “4. Possible side effects”), reduce the amount of
gel per application or the frequency of use of Finacea Gel to once a day, until the irritant
phenomenon disappears. If necessary, discontinue treatment for a few days.

Use in children and adolescents
No dosage adjustment is necessary for the treatment of acne in adolescents aged
between 12 and 18 years.

Duration of treatment
The duration of treatment with Finacea Gel may vary from subject to subject and also depends on the
severity of the skin condition.
Your doctor will determine how long you should use Finacea Gel.

Acne:the use of Finacea Gel can be prolonged for several months depending on the effectiveness of the
treatment.
An evident improvement can be observed after 4 weeks.
If, after 1 month, you do not notice any improvement or if the acne worsens, you should stop the treatment with Finacea Gel and consult your doctor.

Rosacea:the use of Finacea Gel can be prolonged for several months depending on the effect of the
treatment. An evident improvement is observed after 4 weeks of treatment.
If, after 2 months, you do not notice any improvement or if the rosacea worsens, you should stop the treatment with Finacea Gel and consult your doctor.

If you use more Finacea Gel than you should
Even if you have accidentally used more Finacea Gel than you should, it is unlikely that a
harmful effect (intoxication) will occur.
Follow your doctor's instructions exactly and consult him if you have any doubts.

If you forget to use Finacea Gel
Do not use a double dose to make up for a missed dose. Continue application as
prescribed by your doctor.

If you stop using Finacea Gel
If you stop the treatment with Finacea Gel, the skin condition may worsen. Before
stopping the treatment with Finacea Gel, ask your doctor.
If you have any further questions about the use of Finacea Gel, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finacea Gel can cause side effects, although not everybody gets them.
Skin irritations (such as burning and itching) may occur.
In the majority of cases, the irritative symptoms are mild or moderate and their frequency decreases during
therapy.
The side effects observed more frequently included itching, burning and pain at the application site.
During treatment with Finacea Gel, the following side effects may occur, which relate
exclusively to the skin area affected by the application:

Acne:

Very common (may affect more than 1 in 10 people):burning, pain, itching at the application
site.

Common (may affect up to 1 in 10 people):rash, tingling or numbness
(paresthesia), dryness of the skin at the application site .
Uncommon (may affect up to 1 in 100 people):skin reaction to an external
agent (contact dermatitis), abnormal redness of the skin (erythema), scaling, sensation of
heat, discoloration of the skin at the application site.

Rare (may affect up to 1 in 1000):

• Hypersensitivity, which may occur with one or more of the following adverse events: angioedema (rapid swelling under the skin), swelling of the eyes, swelling of the face, dyspnea (shortness of breath)
• Skin irritation
• Urticaria (hives)
• Worsening of asthma

Rosacea:

Very common (may affect more than 1 in 10 people):burning, pain, itching at the
application site.

Common (may affect up to 1 in 10 people):tingling or numbness
(paresthesia), skin dryness, rash, swelling (edema) at the application site.

Uncommon (may affect up to 1 in 100 people):acne, skin reaction to an external
agent (contact dermatitis), abnormal redness of the skin (erythema), urticaria (hives), discomfort at the
application site.

Rare (may affect up to 1 in 1000):

• Hypersensitivity, which may occur with one or more of the following adverse events: angioedema (rapid swelling under the skin), swelling of the eyes, swelling of the face, dyspnea (shortness of breath)
• Skin irritation
• Urticaria (hives)
• Worsening of asthma

Children and adolescents
Treatment of acne vulgaris in adolescents aged 12-18 years:
In clinical studies including adolescents, the total incidence of adverse events of Finacea Gel
was similar to that observed in the entire patient population.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system,
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Finacea Gel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the tube after
“EXP”. The expiry date refers to the last day of that month.
Finacea Gel does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What containsFinacea Gel

• The active ingredient is azelaic acid (each gram of Finacea Gel contains 150 mg of azelaic acid).
• The excipients are: Benzoic acid (E 210), carbomers, disodium edetate, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and medium-chain triglycerides.

Description of the appearance of Finacea Gel and contents of the pack
Finacea Gel is an opaque gel from white to yellowish-white.
Finacea Gel is available in packs of 5, 30 or 50 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.

Manufacturer:
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering, 21
20090 Segrate (Milan), Italy.
Marketing Authorisation Holder in Italy:
LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Finacea: Denmark, France, Iceland, Italy, Norway, Spain, Sweden, United Kingdom.
Skinoren: Austria, Finland, Germany, Greece, Ireland, Portugal.