SKINOREN 200 mg /G Cream

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
   1. 200 mg/g (20%), cream
   2. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Skinoren and what is it used for
   1. Indications
4. Important information before using Skinoren
   1. When not to use Skinoren
   2. Warnings and precautions
   3. Children and adolescents
   4. Skinoren and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Important information about some ingredients of Skinoren
5. How to use Skinoren
   1. Use in children and adolescents
   2. Stopping the use of Skinoren
6. Possible side effects
   1. Reporting side effects
7. How to store Skinoren
8. Contents of the packaging and other information
   1. What Skinoren contains
   2. What Skinoren looks like and what the packaging contains
   3. Marketing authorization holder in Bulgaria, the country of export
   4. Manufacturer
   5. Parallel importer:
   6. Repackaged by:
   7. Date of approval of the leaflet: 31.10.2024

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Skinoren(Скинорен)

200 mg/g (20%), cream

Azelaic acid
Skinoren and Скинорен are the same trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Skinoren and what is it 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 packaging and other information

1. What is Skinoren and what is it used for

Skinoren is an anti-acne medicine in the form of a cream for application to the skin.
The active substance of the medicine is azelaic acid, which has antibacterial effects (inhibits the growth of Propionibacterium acnesbacteria), inhibits excessive keratinization of the skin, reduces 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 skin pigment cells (melanocytes).

Indications

Treatment of common acne and skin hyperpigmentation.

2. Important information before using Skinoren

When not to use Skinoren

Do not use Skinoren if the patient has been diagnosed with hypersensitivity (allergy) to azelaic acid, propylene glycol, or any of the other ingredients of Skinoren (see section 6).

Warnings and precautions

Before starting to take Skinoren, you should consult a doctor or pharmacist. You should avoid contact between the medicine and the eyes, mouth, and mucous membranes.
In case of applying Skinoren to the face, you should be careful not to get the medicine into the eyes. If the medicine comes into contact with the eyes, mouth, or mucous membranes, they should be rinsed immediately with a large

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amount of water. If eye irritation persists, the patient should contact a doctor. After each use of Skinoren, you should wash your hands.

Children and adolescents

The safety and efficacy of using Skinoren in children under 12 years of age have not been studied.

Skinoren and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription. No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

Skinoren should not be used during pregnancy and breastfeeding, unless advised by a doctor.
You should avoid contact between the child being breastfed and the skin or breasts treated with Skinoren.
You should consult a doctor or pharmacist if you are pregnant or breastfeeding, suspect you are pregnant, or plan to become pregnant, before using this medicine.

Driving and using machines

Skinoren has no effect on the ability to drive and use machines.

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 cetearyl alcohol, which may cause a local skin reaction (e.g., contact dermatitis).

3. How to use Skinoren

Skinoren should be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist again.
Skinoren should only be applied to the skin. Before applying Skinoren, you should wash your skin with ordinary water and dry it. You can also use a mild preparation for cleaning the skin.
Unless your doctor advises otherwise, a thin layer of cream should be applied to the affected skin twice a day - in the morning and evening. The cream should be gently rubbed in. A strip of cream squeezed from the tube, about 2.5 cm long (about 0.5 g), is enough for the face. After applying the medicine, you should wash your hands.
The duration of treatment with Skinoren varies from person to person and depends on the severity of skin changes.
In the treatment of common acne, significant improvement is achieved after about 4 weeks of regular use of the medicine. To achieve the best treatment results, you should use the medicine regularly for several months, up to a maximum of 12 months.
In the treatment of hyperpigmentation, it is recommended to use Skinoren for at least 3 months. The best results are achieved by using the medicine regularly. Since sunlight can exacerbate skin hyperpigmentation, during the entire treatment period, you should also use creams with UVB and UVA filters.
If there is significant skin irritation, you should reduce the amount of medicine used or use it once a day until the irritation symptoms subside. If necessary, you should stop the treatment for a few days.

Use in children and adolescents

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The medicine should be used in adolescents (aged 12-18) for the treatment of common acne. Dose adjustment is not necessary in adolescents aged 12-18.
There are no data on the safety and efficacy of using Skinoren in children under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Stopping the use of Skinoren

If skin irritation persists during the use of Skinoren, you should stop the treatment for a few days.

4. Possible side effects

Like all medicines, Skinoren can cause side effects, although not everybody gets them.
At the beginning of treatment, skin irritation may occur.
The following list of side effects is based on reports from clinical trials and spontaneous reports as a result of monitoring the safety of the medicine after its authorization. The listed side effects are ordered according to their frequency of reporting and occurrence.
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):

• seborrheic dermatitis, acne, skin discoloration, paresthesia (tingling, numbness), skin inflammation, 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 side effects: angioedema, contact dermatitis, eye edema, facial edema), worsening of asthma symptoms, urticaria, cheilitis, rash, burning sensation, blisters, eruption, ulceration at the application site. The listed side effects have been reported after the authorization of Skinoren cream.

If you experience any side effects, including any side effects not listed in this leaflet, you should consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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
By reporting side effects, you can help gather more information on the safety of the medicine.

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5. How to store Skinoren

Store at a temperature below 30°C.
Store in a place 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 specified month.
Shelf life after first opening the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Skinoren contains

The active substance of the medicine is azelaic acid.
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, cetearyl alcohol, propylene glycol, purified water, macrogol stearate.

What Skinoren looks like and what the packaging contains

Skinoren is a white cream. The aluminum tube contains 30 g of cream.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 20000455
Parallel import authorization number: 383/24

Date of approval of the leaflet: 31.10.2024

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[Information about the trademark]

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