Skinoren

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Skinoren

200 mg/g, cream
Acidum azelaicum

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Skinoren and what is it used for
• 2. Important information before using Skinoren
• 3. How to use Skinoren
• 4. Possible side effects
• 5. How to store Skinoren
• 6. Contents of the packaging and other information

1. What is Skinoren and what is it used for

Skinoren is an anti-acne medicine in the form of a cream for application to the skin.
The active substance of the medicine is azelaic acid, which has antibacterial properties (inhibits the growth of Propionibacterium acnesbacteria), inhibits excessive keratinization of the epidermis, reduces the amount of free fatty acids on the skin surface, and reduces the number of comedones. Additionally, azelaic acid inhibits the growth and excessive activity of abnormal pigment cells in the epidermis (melanocytes).
Indications
Treatment of common acne and skin hyperpigmentation.

2. Important information before using Skinoren

When not to use Skinoren

Do not use Skinoren if the patient has been found to be hypersensitive (allergic) to azelaic acid, propylene glycol, or any of the other ingredients of Skinoren (see section 6).

Warnings and precautions

Before starting to take Skinoren, you should consult a doctor or pharmacist.
contact with the eyes, mouth, and mucous membranes should be avoided.
When using Skinoren on the face, care should be taken to avoid getting the medicine in the eyes.
If the medicine comes into contact with the eyes, mouth, or mucous membranes, they should be rinsed immediately with a large amount of water. If eye irritation persists, the patient should consult a doctor. After each use of Skinoren, the hands should be washed.

Children and adolescents

The safety and efficacy of Skinoren in children under 12 years of age have not been established.

Skinoren and other medicines

The doctor should be informed about all medicines currently being taken or recently taken, including those available without a prescription. No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

Skinoren should not be used during pregnancy and breastfeeding, unless advised by a doctor.
Contact between the child being breastfed and the skin or breasts treated with Skinoren should be avoided.
A doctor or pharmacist should be consulted if the woman is pregnant or breastfeeding, suspects she is pregnant, or plans to become pregnant, before using this medicine.

Driving and using machines

Skinoren has no influence on the ability to drive and use machines.

Important information about some ingredients of Skinoren

Skinoren cream contains 2 mg of benzoic acid per 1 g of cream. Benzoic acid may cause local skin irritation.
Skinoren cream contains 125 mg of propylene glycol per 1 g of cream.
Skinoren contains cetearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Skinoren

Skinoren should be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted again.
Skinoren should be used exclusively on the skin. Before using Skinoren, the skin should be thoroughly washed with ordinary water and dried. A mild skin cleanser can also be used.
Unless otherwise directed by the doctor, a thin layer of cream should be applied to the affected skin twice a day, in the morning and evening. The cream should be gently rubbed in. A strip of cream about 2.5 cm long (about 0.5 g) is sufficient for the face. After applying the medicine, the hands should be washed.
The duration of treatment with Skinoren varies from patient to patient and depends on the severity of skin lesions.
In the treatment of common acne, significant improvement is usually seen after about 4 weeks of systematic use of the medicine. To achieve optimal treatment results, the medicine should be used systematically for several months, up to a maximum of 12 months.
In the treatment of hyperpigmentation, it is recommended to use Skinoren for at least 3 months. The best results are achieved by using the medicine systematically. Since sunlight can exacerbate skin hyperpigmentation, sunscreens with UVB and UVA filters should be used during the entire treatment period.
In case of significant skin irritation, the amount of medicine used should be reduced or it should be applied once a day until the irritation symptoms subside. If necessary, treatment should be interrupted for a few days.

Use in children and adolescents

The medicine should be used in adolescents (aged 12-18) for the treatment of common acne. Dose adjustment is not necessary in adolescents aged 12-18.
There are no data on the safety and efficacy of Skinoren in children under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Discontinuation of Skinoren

If skin irritation persists during the use of Skinoren, treatment should be interrupted for a few days.

4. Possible side effects

Like all medicines, Skinoren can cause side effects, although they may not occur in everyone.
At the beginning of treatment, skin irritation may occur.
The following list of side effects is based on reports from clinical trials and spontaneous reports as a result of monitoring the safety of the medicine after its authorization. The listed side effects are ordered according to their frequency of reporting and occurrence.
Very common(may occur in more than 1 in 10 people):

• itching, burning sensation, redness at the application site; Common(may occur in up to 1 in 10 people):
• peeling of the skin, pain, dryness, skin discoloration, irritation at the application site; Uncommon(may occur in up to 1 in 100 people):
• seborrheic dermatitis, acne, skin discoloration, paresthesia (tingling, numbness), skin inflammation, discomfort, swelling at the application site; Rare(may occur in up to 1 in 1000 people):
• hypersensitivity to the medicine (which may manifest as one of the following side effects: angioedema, contact dermatitis, eye edema, facial edema), worsening of asthma symptoms, urticaria, cheilitis, rash, burning sensation, blisters, eruption, ulceration at the application site

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Skinoren

Store at a temperature below 30°C, in the original packaging.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after opening the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Skinoren contains

The active substance of the medicine is azelaic acid.
1 g of cream contains 200 mg of azelaic acid.
The other ingredients are: benzoic acid (E 210), cetearyl octanoate + isopropyl myristate (PCL Liquid), glycerol 85%, glycerol monostearate 40-55, cetearyl alcohol, propylene glycol, purified water, macrogol stearate.

What Skinoren looks like and what the packaging contains

Skinoren is a white cream. The aluminum tube contains 30 g of cream.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

LEO PHARMA A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer:

Leo Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20054 Segrate (Milan)
Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 11427/2019/01

Parallel import authorization number: 342/17

Date of leaflet approval: 14.07.2025

[Information about the trademark]