SKINOREN*CREAM 30G 20%

Skinoren 20% cream
Azelaic acid

What it is and what it is used for
Skinoren is an anti-acne preparation for topical use (on the skin).

Skinoren is used for the treatment of acne (acne vulgaris) in its various forms, characterized by the presence of comedones (blackheads), papules, pustules (pimples), and small nodules.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
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.

The product is for skin application only.

Pay particular attention when using this medicine:
- during pregnancy or breastfeeding (see section Pregnancy and breastfeeding);
- if you suffer from asthma, as a worsening of asthma symptoms has rarely been reported in some patients treated with azelaic acid.

Avoid contact with eyes, mouth, and mucous membranes. In case of accidental contact, wash the affected areas with plenty of water. If eye irritation persists, consult your doctor.

Wash your hands after each application of Skinoren.

Limit as much as possible the concomitant use of cosmetic preparations and alcoholic or aggressive cleansers, dyes, astringent or abrasive substances, or exfoliating agents that can worsen the acne condition. For the choice of appropriate products, ask your doctor or pharmacist for advice.

If after a short period of treatment you do not notice appreciable results, consult your doctor.

Also consult your doctor if these disorders have occurred in the past.

Possible side effects
Like all medicines, Skinoren cream can cause side effects, although not everyone experiences them.

Mostly, burning at the application site, itching, or erythema (redness) may occur. Usually, irritation symptoms are mild and disappear during treatment. The following side effects are based on the results of clinical studies and post-marketing surveillance with Skinoren cream.
Side effects are listed according to the frequency with which they have been observed.

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

Common: may affect up to 1 in 10 people
- desquamation (peeling and flaking) at the application site,
- pain at the application site,
- dryness at the application site,
- discoloration at the application site,
- irritation at the application site.

Uncommon: may affect up to 1 in 100 people
- seborrhea (excessively oily skin),
- acne,
- skin depigmentation (discoloration),
- paresthesia at the application site (sensation of tingling, tickling, pricking, stinging, burning),
- dermatitis at the application site,
- discomfort at the application site,
- edema at the application site (swelling).

Rare: may affect up to 1 in 1000 people
- hypersensitivity to the medicine (which may occur with angioedema¹, contact dermatitis¹, eye swelling¹, facial swelling¹),
- worsening of asthma,
- urticaria¹,
- cheilitis (inflammation of the lips),
- rash¹,
- sensation of warmth at the application site,
- vesicles at the application site (small fluid-filled sacs),
- eczema at the application site,
- ulcer at the application site.

¹these side effects have been reported in patients using Skinoren cream during commercialisation.

If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.