FINACEA*GEL 30G 15%

Finacea 15% Gel
Azelaic acid

What it is and what it is used for
Finacea Gel contains the active ingredient azelaic acid and belongs to the category of anti-acne preparations for external (cutaneous) use. Finacea Gel is indicated for the relief of mild to moderate papulopustular acne on the face and for the treatment of papulopustular rosacea. Papulopustular acne and rosacea are associated with the presence of inflammatory papules and pustules.

What you need to know before taking the medicine
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. Avoid contact with eyes, mouth, and other mucous membranes. In case of accidental contact, wash the affected eyes, mouth, and/or 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, abrasive or exfoliating (peeling) products when Finacea Gel is used for the treatment of rosacea.
Rarely, worsening of asthma symptoms has been reported in some patients treated with azelaic acid.

Children and adolescents
The 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 the 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 the 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.

Possible side effects
Like all medicines, Finacea Gel can cause side effects, although not everybody gets them.

Skin irritations (e.g., burning and itching) may occur.
In most cases, irritative symptoms are mild to moderate and their frequency decreases during therapy.
The most frequently observed side effects included itching, burning and pain at the application site.
The following side effects, which exclusively affect the skin area where it is applied, may occur during treatment with Finacea Gel:

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):
- skin rash,
- tingling or numbness (paresthesia),
- dry 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,
- skin discoloration at the application site.

Rare (may affect up to 1 in 1000 people)¹: - hypersensitivity, which may occur with one or more of the following adverse events: angioedema (rapid swelling under the skin), eye swelling, facial swelling, dyspnea (shortness of breath)
- skin irritation
- urticaria
- worsening of asthma
¹ these side effects have been reported in patients using azelaic acid during the post-marketing phase.

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),
- dry skin,
- skin 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,
- discomfort at the application site.

Rare (may affect up to 1 in 1000 people)¹:
- hypersensitivity, which may occur with one or more of the following adverse events: angioedema (rapid swelling under the skin), eye swelling, facial swelling, dyspnea (shortness of breath)
- skin irritation
- urticaria
- worsening of asthma
¹ these side effects have been reported in patients using azelaic acid during the post-marketing phase.

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.