Skinoren

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Skinoren

200 mg/g (20%), cream

Azelaic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack 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 effects (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 you are allergic (hypersensitive) to azelaic acid, propylene glycol, or any of the other ingredients of Skinoren (see section 6).

Warnings and precautions

Before using Skinoren, consult your doctor or pharmacist.
Avoid contact of the medicine with eyes, mouth, and mucous membranes.
When using Skinoren on the face, be careful not to get the medicine in your eyes.
If the medicine comes into contact with your eyes, mouth, or mucous membranes, rinse them immediately with plenty of water. If eye irritation persists, you should consult a doctor. After each use of Skinoren, wash your hands.

Children and adolescents

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

Skinoren and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription. No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

Do not use Skinoren during pregnancy or breastfeeding unless your doctor has advised you to do so.
Avoid contact between the child you are breastfeeding and the skin or breasts treated with Skinoren.
Consult your doctor or pharmacist if you are pregnant, breastfeeding, think you may be pregnant, or plan 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

Use Skinoren as directed by your doctor. If you are unsure, consult your doctor or pharmacist again.
Use Skinoren only on the skin. Before using Skinoren, wash your skin with plain water and dry it. You can also use a mild skin cleanser.
Unless your doctor advises otherwise, apply a thin layer of cream to the affected skin twice a day, in the morning and evening. Gently rub in the cream. A strip of cream about 2.5 cm long (about 0.5 g) is enough for the face. After applying the medicine, wash your hands.
The duration of treatment with Skinoren varies from person to person and depends on the severity of skin lesions.
In the treatment of common acne, significant improvement is usually seen after about 4 weeks of regular use of the medicine. To achieve optimal treatment results, it is recommended to use the medicine 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, during the entire treatment period, it is recommended to use UVB and UVA filter creams at the same time.
If significant skin irritation occurs, reduce the amount of medicine used or apply it once a day until the irritation symptoms subside. If necessary, stop treatment for a few days.

Use in children and adolescents

Use the medicine in adolescents (12 to 18 years old) for the treatment of common acne. No dose adjustment is necessary for adolescents between 12 and 18 years old.
There are no data on the safety and efficacy of Skinoren in children under 12 years old.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Stopping the use of Skinoren

If skin irritation persists during the use of Skinoren, stop treatment 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 as a result of monitoring the safety of the medicine after it was placed on the market. The listed side effects are ordered by 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):

• seborrheic 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 marketing authorization of Skinoren cream.

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skinoren

Do not store above 30°C.
Keep out of the 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 stated.
Shelf life after first opening the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 contents of the pack

Skinoren is a white cream. The aluminum tube with an inner layer of epoxy resin and a polyethylene cap in a cardboard box contains 30 g of cream.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Austria, the country of export: 1-18823

Parallel import authorization number: 279/24

Date of approval of the leaflet: 05.07.2024

[Information about the trademark]