Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Skinoren, 200 mg/g, cream
Acidum azelaicum
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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

What Skinoren is and what it is used for
Important information before using Skinoren
How to use Skinoren
Possible side effects
How to store Skinoren
Contents of the pack and other information

1. What Skinoren is and what it is used for

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

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 to 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 medicinal product with the 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 the eyes, mouth, or mucous membranes, rinse immediately with a large 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 and other medicines
Inform your doctor about all medicines currently used or recently used, 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 between a breastfed infant and the treated skin or breasts of a person using Skinoren.
Consult a doctor or pharmacist if you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, before using this medicinal product.

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

Important information about certain ingredients of Skinoren
Skinoren contains 2 mg of benzoic acid (E 210) per 1 g of cream. Benzoic acid (E 210) may cause local skin irritation.
Skinoren contains 125 mg of propylene glycol per 1 g of cream.
Skinoren contains cetearyl alcohol and may therefore cause local skin reactions (e.g. contact dermatitis).

3. How to use Skinoren

Use Skinoren exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
Skinoren is for topical use only. Before applying Skinoren, wash the skin thoroughly with plain water and dry it. You may also use a mild skin-cleansing product.
Unless otherwise advised by your doctor, a thin layer of cream should usually be applied twice daily—morning and evening—on the affected skin areas. Gently rub in the cream. A strip of cream squeezed from the tube approximately 2.5 cm long (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 individuals and depends on the severity of skin lesions.
In the treatment of acne vulgaris, noticeable improvement is usually observed after approximately 4 weeks of regular use. For optimal treatment results, use the medication regularly for several months, up to a maximum of 12 months.
For the treatment of skin pigmentation disorders, Skinoren is recommended for at least 3 months. Best results are achieved with consistent, regular use. Since sunlight exposure may worsen pigmentation, during the entire treatment period sunscreen products protecting against both UV B and UV A radiation should be used simultaneously.
If significant skin irritation occurs, reduce the amount of medication applied or apply it once daily until symptoms of irritation subside. If necessary, discontinue treatment for several days.
Use in children and adolescents
Skinoren can be used 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 Skinoren 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 persists during treatment with Skinoren, discontinue treatment for several days.

4. Possible adverse reactions

Like any medicinal product, Skinoren may cause adverse reactions, although not everybody experiences them.
At the beginning of treatment, skin irritation may occur.
The list below is based on reports from clinical trials and spontaneous reports from post-marketing safety monitoring. The adverse reactions listed below are arranged according to 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 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 (pricking, tingling sensation), dermatitis, discomfort, swelling at the application site;

Rare (may occur in 1 in 1000 people):

hypersensitivity reactions (which may manifest as one of the following adverse reactions: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, burning, blisters, exanthema, ulceration at the application site. The above-mentioned adverse reactions were reported after marketing authorization of Skinoren.

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 of Adverse Drug Reactions of the Office for Registration 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.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Skinoren

Store below 30°C, in the original packaging.
Keep the medicine 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 stated month.
Period of use after first opening the immediate packaging: 6 months.
Medicines must 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 package and other information

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

What Skinoren looks like and contents of the pack
Skinoren is a white cream. 30 g tube in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Responsible party in Romania, 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, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorization number in Romania, country of export: 11427/2019/01
Parallel import authorization number: 101/21