Skinoren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Skinoren (Skinoren)
200 mg/g (20%), cream
Acidum azelaicum
Skinoren and Скинорен are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Skinoren is and what it is used for
2. What you need to know 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 Skinoren is and what it is used for

Skinoren is an anti-acne medicine in the form of a cream for topical application.
The active substance is azelaic acid, which has antibacterial activity (inhibits the growth of Propionibacterium acnes bacteria), reduces excessive keratinization of the epidermis, decreases 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 epidermal pigment cells (melanocytes).
Indications
Treatment of acne vulgaris and skin pigmentation disorders.

2. Important information before using Skinoren

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

Warnings and precautions
Before starting treatment with Skinoren, consult a doctor or pharmacist. Avoid contact of the product with eyes, mouth, and mucous membranes.

When applying Skinoren to the facial skin, care should be taken to prevent the product from entering the eyes. In case of contact with eyes, mouth, or mucous membranes, rinse immediately with a large

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amount of water. If eye irritation persists, the patient should contact a doctor. Hands should be washed after each application of Skinoren.

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

Skinoren with other medicines
Inform your doctor about all medicines currently or recently taken, including those obtained without a prescription. No studies on interactions have been conducted.

Pregnancy, breastfeeding, and fertility
Do not use Skinoren during pregnancy or breastfeeding unless advised by a doctor.

Avoid contact of the breastfed infant with skin treated with Skinoren or with the breasts.

Consult a doctor or pharmacist if a woman is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, before using this medicine.

Driving and operating machinery
Skinoren has no effect on the ability to drive or operate machinery.

Important information about certain 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 cetostearyl alcohol and may therefore cause local skin reactions (e.g. contact dermatitis).

3. How to use Skinoren

Skinoren should be used as directed by the physician. In case of doubt, consult your doctor or pharmacist again.
Skinoren is for topical use only. Before applying Skinoren, thoroughly wash the skin with plain water and dry it. A mild skin-cleansing product may also be used.
Unless otherwise advised by a physician, a thin layer of cream should usually be applied to the affected skin twice daily – in the morning and evening. Gently rub in the cream. A strip of cream squeezed from the tube, approximately 2.5 cm in length (about 0.5 g), is sufficient for the entire face. Hands should be washed after applying the medication.
The duration of treatment with Skinoren varies between individual patients and depends on the severity of skin lesions.
In the treatment of acne vulgaris, noticeable improvement is usually achieved after approximately 4 weeks of regular use. To obtain optimal treatment results, the medication should be used regularly for several months, up to a maximum of 12 months.
For the treatment of skin pigmentation disorders, Skinoren is recommended for use for at least 3 months. Best results are achieved with consistent, regular use. Since sunlight exposure may worsen skin pigmentation, sunscreen products containing both UV B and UV A filters should be used throughout the entire treatment period.
If significant skin irritation occurs, reduce the amount of medication applied or apply once daily until symptoms of irritation subside. If necessary, discontinue treatment for several days.

Use in children and adolescents

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Skinoren is indicated for use in adolescents (aged 12 to 18 years) for the treatment of acne vulgaris. Dose adjustment in adolescents aged 12 to 18 years is not required.
There is insufficient data on the safety and efficacy of use in children under 12 years of age.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Discontinuation of Skinoren
If skin irritation symptoms persist during treatment with Skinoren, discontinue treatment for several days.

4. Possible adverse reactions

Like all medicines, Skinoren may cause adverse reactions, although not everyone experiences them.
Skin irritation may occur at the beginning of treatment.
The list below of adverse reactions is based on reports from clinical trials and spontaneous reports following post-marketing safety monitoring of the medicinal product. The adverse reactions listed below are categorized according to their frequency of occurrence and reporting.

Very common (may occur in more than 1 in 10 people):

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

Common (may occur in 1 in 10 people):

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

Uncommon (may occur in 1 in 100 people):

• seborrhoeic dermatitis, acne, skin discoloration, paraesthesia (prickling, tingling sensations), dermatitis, discomfort, swelling at the application site;

Rare (may occur in 1 in 1,000 people):

• hypersensitivity to medicines (which may manifest as one of the following adverse reactions: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, stinging, blistering, exanthema, ulceration at the application site. The adverse reactions listed above were reported after marketing authorization of Skinoren cream.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting adverse reactions enables better assessment of the medicine's safety profile and helps to gather additional information on its safe use.

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5. How to store Skinoren

Store below 30°C.
Keep 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 stated month.
Shelf life after first opening of 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. Package contents and other information

What Skinoren contains
The active substance is azelaic acid.
Each 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, cetostearyl alcohol, propylene glycol, purified water, macrogol glyceryl stearates.

What Skinoren looks like and contents of the pack
Skinoren is a white cream. The aluminium tube contains 30 g of cream.

For more detailed information, please contact the responsible entity or the parallel importer.

Responsible entity 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
20090 Segrate (Milan)
Italy

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Marketing Authorization number in Bulgaria, the country of export: 20000455
Parallel import authorization number: 383/24

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