Skinoren

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Skinoren, 200 mg/g, cream

Acidum azelaicum

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

• You should 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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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 skin pigment cells (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 diagnosed with hypersensitivity (allergy) 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.
You should avoid contact between the medicine and the eyes, mouth, and mucous membranes.
When using Skinoren on the face, you should be careful not to get 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, you should wash your hands.

Children and adolescents

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

Skinoren and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are 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.
You should avoid contact between the child being breastfed and the skin or breasts being treated with Skinoren.
You should consult a doctor or pharmacist if you are pregnant or breastfeeding, suspect you are pregnant, or plan to become pregnant, before using this medicine.

Driving and using machines

Skinoren has no effect on the ability to drive vehicles or operate machinery.

Important information about some ingredients of Skinoren

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

3. How to use Skinoren

Skinoren should be used as directed by a doctor. If you have any doubts, you should consult a doctor or pharmacist again.
Skinoren should only be applied to 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 a 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, you should wash your hands.
The duration of treatment with Skinoren varies from person to person and depends on the severity of the skin changes.
In the treatment of common acne, significant improvement is usually seen after about 4 weeks of regular use of the medicine. To achieve the best treatment results, the medicine should be used regularly 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 regularly. Since sunlight can exacerbate skin hyperpigmentation, sunscreens with UVB and UVA filters should be used during the entire treatment period.
If significant skin irritation occurs, 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 years) for the treatment of common acne. Dose adjustment is not necessary in adolescents aged 12-18 years.
There are no data on the safety and efficacy of using 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.

Stopping the use 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 not everybody gets them.
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 from post-marketing surveillance of the medicine. The listed side effects are ranked according to frequency of reporting and occurrence.
Very common(may affect more than 1 in 10 people):

• itching, burning sensation, redness at the application site;

Common(may affect up to 1 in 10 people):

• skin peeling, pain, dryness, skin discoloration, irritation at the application site;

Uncommon(may affect up to 1 in 100 people):

• seborrhoeic dermatitis, acne, skin discoloration, paresthesia (tingling, numbness), skin inflammation, discomfort, swelling at the application site;

Rare(may affect 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. These side effects have been reported after the medicine was placed on the market.

If you experience any side effects, including any side effects not listed in this leaflet, you should consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Skinoren

Store at a temperature below 30°C.
The medicine should be stored 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 first opening the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 containing 30 g of cream, with a PE cap, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20000455
Parallel import authorization number:112/20

Date of leaflet approval: 04.03.2025

[Information about the trademark]