Patient Information Leaflet

Warning! Keep this leaflet! 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, 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 package 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 in Skinoren is azelaic acid, which has antibacterial activity (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. Additionally, azelaic acid
inhibits the proliferation and hyperactivity 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 has hypersensitivity (allergy) 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 eyes, mouth, and mucous membranes.
When applying Skinoren to facial skin, care must be taken to prevent the product from entering the eyes.
In case of contact with eyes, mouth, or mucous membranes, rinse immediately with plenty 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 have not been established in children under 12 years of age.

Skinoren with other medicines
Inform your doctor about all medicines currently used or recently used, including those obtained without a prescription. Interactions have not been studied.

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 breasts.
Consult a doctor or pharmacist if you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, before using this medicinal product.

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

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, thoroughly wash the skin with plain water and dry it. You may also use a mild cleanser suitable for skin cleansing.
Unless otherwise advised by your doctor, 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 long (about 0.5 g) is sufficient for the entire face. After application, wash your hands.
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 seen after about 4 weeks of regular use. For optimal treatment results, Skinoren should be used regularly for several months, up to a maximum of 12 months.
For the treatment of skin hyperpigmentation, Skinoren should be used for at least 3 months. Best results are achieved with consistent, regular use. Since sunlight may worsen skin pigmentation, sunscreen products providing protection against both UV B and UV A radiation should be used throughout the entire treatment period.
If significant skin irritation occurs, reduce the amount of cream applied or apply once daily until symptoms of irritation subside. If necessary, discontinue treatment for a few 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 that the effect of the medicine is too strong or too weak, consult your doctor.
Discontinuation of Skinoren treatment
If symptoms of skin irritation persist during treatment with Skinoren, treatment should be interrupted for a few days.

4. Possible adverse reactions

Like all medicines, Skinoren may cause adverse reactions, although not everybody gets them.
At the beginning of treatment, skin irritation may occur.
The list of adverse reactions below is based on reports from clinical trials and spontaneous reports from post-marketing safety monitoring. The adverse reactions listed below are categorized according to frequency of occurrence and reporting.

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, paraesthesia (pricking or tingling sensation), dermatitis, feeling of 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 adverse reactions: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, burning, blisters, eruption, ulceration at the application site.

The above-mentioned adverse reactions were reported after marketing 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder or to the parallel importer.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Skinoren

Store below 30°C in the original packaging.
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.
Use within 6 months after first opening the immediate packaging.
Medicines should 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 packaging 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 glycerides stearates.

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

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

Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Authorization number in Romania, country of export: 11427/2019/01
Parallel import authorization number: 72/26