Skinoren

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Skinoren

200 mg/g (20%), cream

Acidum azelaicum
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.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents 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 topical use.
The active substance of the medicine is azelaic acid, which has antibacterial properties (inhibits the growth of Propionibacterium acnesbacteria), inhibits excessive keratinization of the epidermis, 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 pigment cells of the epidermis (melanocytes).
Indications
Treatment of common acne and skin hyperpigmentation.

2. Important information before using Skinoren

When not to use Skinoren

Skinoren should not be used if the patient has been diagnosed with hypersensitivity (allergy) to azelaic acid, propylene glycol, or any other component of Skinoren (see section 6).

Warnings and precautions

Before starting to use Skinoren, you should consult a doctor or pharmacist.
Contact between the medicine and the eyes, mouth, and mucous membranes should be avoided.
When using Skinoren on the face, care should be taken to avoid getting the medicine in the eyes.
If the medicine comes into contact with the eyes, mouth, or mucous membranes, they should be rinsed immediately with a large amount of water. If eye irritation persists, the patient should consult a doctor. After each use of Skinoren, the hands should be washed.

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

The doctor should be informed about all medicines currently being taken or recently taken, including those 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.
Contact between the child being breastfed and the skin or breasts treated with Skinoren should be avoided.
A doctor or pharmacist should be consulted if the woman is pregnant or breastfeeding, suspects she is pregnant, or plans to become pregnant before using this medicine.

Driving and using machines

Skinoren does not affect 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 the doctor. In case of doubts, the doctor or pharmacist should be consulted again.
Skinoren should be used exclusively on the skin. Before using Skinoren, the skin should be thoroughly washed with ordinary water and dried. A mild skin cleansing preparation can also be used.
Unless otherwise advised by the doctor, 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 sufficient for the face. After applying the medicine, the hands should be washed.
The duration of treatment with Skinoren varies from patient to patient and depends on the severity of skin lesions.
In the treatment of common acne, significant improvement is usually achieved after about 4 weeks of systematic use of the medicine. To achieve the best treatment results, the medicine should be used systematically 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 systematically. Since sunlight can exacerbate skin hyperpigmentation, sunscreens with UVB and UVA filters should be used during the entire treatment period.
In case of significant skin irritation, the amount of medicine used should be reduced or applied once a day until the irritation symptoms subside. If necessary, treatment should be discontinued for a few days.

Use in children and adolescents

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.

Discontinuation of Skinoren

If skin irritation symptoms persist during the use of Skinoren, treatment should be discontinued for a few days.

4. Possible side effects

Like all medicines, Skinoren can cause side effects, although they may not occur in everyone.
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 from post-marketing surveillance of the medicine. The listed side effects are ordered by 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 up to 1 in 10 people):
• skin peeling, pain, dryness, skin discoloration, irritation at the application site; Uncommon(may occur in up to 1 in 100 people):
• seborrheic dermatitis, acne, skin discoloration, paresthesia (tingling, numbness), skin inflammation, discomfort, swelling at the application site; Rare(may occur in 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. These side effects have been reported after the marketing authorization of Skinoren cream.

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects can help gather more information on the safety of the medicine.

5. How to store Skinoren

Store at a temperature below 30°C.
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 month.
Shelf life after first opening the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents 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 package contains

Skinoren is a white cream.
An aluminum tube with a PE cap containing 30 g of cream.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

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, 20054 Segrate (Milan), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20000455

Parallel import authorization number: 126/21

Date of leaflet approval: 08.01.2024

[Information about the trademark]