SKINOREN

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Skinoren, 200 mg/g (20%) cream
Acidum azelaicum
Please read carefully all the information 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Skinoren is and what it is 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 Skinoren is and what it is used for

Skinoren is an anti-acne medicine in the form of a topical cream.
The active substance is azelaic acid, which has antibacterial activity (inhibits the growth of Propionibacterium acnes), 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 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 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 the facial skin, care should be taken to avoid contact with the eyes.
If the medicinal product comes into contact with the 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 in children under 12 years of age have not been established.

Skinoren with 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 of the nursing infant with the skin or breasts treated with Skinoren.
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 influence on the ability to drive or operate machinery.

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 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 cleanser may also be used.
Unless otherwise directed by a physician, a thin layer of cream should usually be applied to the affected skin twice daily – in the morning and evening. The cream should be gently rubbed in. 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 among individual patients and depends on the severity of skin lesions.
In the treatment of acne vulgaris, noticeable improvement is usually seen after approximately 4 weeks of regular use. For 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 at least 3 months. Best results are achieved with consistent, regular use. Since sunlight exposure may worsen 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 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 the effect of the medication seems 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 effects

Like all medicines, Skinoren may cause adverse effects, although not everyone experiences them.
At the beginning of treatment, skin irritation may occur.
The list of adverse effects below is based on reports from clinical trials and spontaneous reports following monitoring of the medicine's safety after its marketing authorization. The adverse effects listed below are categorized according to 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 (pricking, tingling sensation), dermatitis, sensation of 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 effects: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, burning, blisters, eruption, ulceration at the application site. The above adverse effects were reported after marketing authorization of Skinoren cream.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to gather more information on the safety of the medicine.

5. How to store Skinoren

Do not store above 30°C.
Keep in a place inaccessible and out of sight of children.
Do not use this medicinal product 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 pack and other information

What Skinoren contains
The active substance is azelaic acid.
1 g of cream contains 200 mg (20%) of azelaic acid.
The other ingredients are: benzoic acid (E 210), cetearyl octanoate + isopropyl myristate
(PCL Liquid), glycerol 85%, glyceryl monostearate 40-55, cetostearyl alcohol, propylene glycol,
purified water, macrogol glyceryl stearate.

What Skinoren looks like and contents of the pack
Skinoren is a white cream. It is supplied in an aluminium tube with an internal epoxy resin
coating and a polyethylene cap, packed in a cardboard box containing 30 g of cream.

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

Responsible party 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:
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

Austria, country of export, marketing authorisation number: 1-18823
Parallel import authorisation number: 452/21