PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Skinoren
150 mg/g, gel
Acidum azelaicum
Please read carefully the information contained in this leaflet 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 topical gel.
The active substance in the medicine is azelaic acid, which has antibacterial properties (inhibits
the growth of Propionibacterium acnes bacteria), inhibits excessive keratinization of the epidermis, reduces the amount of
fatty acids on the skin surface, and decreases the number of comedones.
Indications
Treatment of mild to moderate facial papulopustular acne.

2. Information before using Skinoren

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

Warnings and precautions
Before starting treatment with Skinoren, consult a doctor or pharmacist.
Avoid contact of the medicinal 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.
If Skinoren comes into 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.
Rare cases of asthma exacerbation have been reported in patients treated with azelaic acid after the product was introduced to the market.

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

Skinoren and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
No studies on interactions have been conducted.

Pregnancy, breastfeeding, and fertility
Before using any medicinal product, consult a doctor.
Do not use Skinoren during pregnancy or breastfeeding unless otherwise directed by a doctor.
Avoid contact between the newborn and the skin or breasts treated with Skinoren.

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

Important information about certain ingredients of Skinoren
Skinoren gel contains 1 mg of benzoic acid per 1 g of gel. Benzoic acid may cause local skin irritation.
Skinoren gel contains 120 mg of propylene glycol per 1 g of gel.

3. How to use Skinoren

Skinoren should be applied to the skin only.
Before applying Skinoren, the skin should be thoroughly washed with plain water and dried. A mild
skin-cleansing product may also be used.
Unless otherwise directed by a physician, a thin layer of the product should usually be applied to
affected skin areas twice daily – in the morning and evening. The gel should be gently rubbed in.
A strip of gel squeezed from the tube, approximately 2.5 cm long (about 0.5 g), is sufficient to
cover the entire facial skin.
Hands should be washed after applying the medication.
Occlusive dressings (sealed coverings) should not be used over the area where the medication has
been applied.
The duration of treatment with Skinoren varies between individual patients and depends on the
severity of skin lesions.
Regular use of Skinoren gel throughout the entire treatment period is very important.
Noticeable improvement is usually seen after approximately 4 weeks of consistent use. For optimal
treatment results, the medication should be used regularly for several months.
If significant skin irritation occurs, the amount of medication used should be reduced or it should
be applied once daily until symptoms of irritation subside. If necessary, treatment should be
discontinued for several days.
Use in children and adolescents
The medication may be used in adolescents (aged 12 to 18 years) for the treatment of
papulopustular acne. 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 symptoms of irritation persist during treatment with Skinoren, treatment should be interrupted
for several days.

4. Possible adverse reactions

Like any medicine, Skinoren can cause adverse reactions, although not everyone experiences them.
The following undesirable symptoms may occur in some patients using Skinoren.

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

itching, burning sensation, pain at the application site;

Common (may occur in 1 in 10 people):

dryness, rash, paraesthesia (pricking, tingling sensation) at the application site;

Uncommon (may occur in 1 in 100 people):

contact dermatitis, erythema, skin desquamation, sensation of warmth, skin depigmentation at the application site;

Rare (may occur in not more than 1 in 1000 people):

hypersensitivity, which may present with one or more of the following adverse reactions: angioedema (sudden swelling of the skin), eye swelling, facial swelling, dyspnoea ("shortness of breath");
skin irritation;
urticaria;
worsening of asthma symptoms.

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

Children and adolescents
Treatment of acne vulgaris in adolescents (aged 12 to 18 years)
In clinical studies, the overall incidence of adverse reactions in adolescents included in the studies was similar to that in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 further accumulation of information on the safety of the medicine.

5. How to store Skinoren

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Skinoren contains
The active substance is azelaic acid.
1 g of gel contains 150 mg of azelaic acid.
The other ingredients are: propylene glycol, polysorbate 80, lecithin, carbomers, medium-chain triglycerides, sodium hydroxide, disodium edetate, benzoic acid, purified water.

What Skinoren looks like and contents of the pack
Skinoren is a white or yellowish-white, opaque gel.
The pack consists of an aluminium tube containing 50 g of gel, placed 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
20090 Segrate (Milan)
Italy

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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Number of marketing authorisation in Romania, country of export: 11426/2019/03
Number of parallel import authorisation: 36/22