Skinoren

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

150 mg/g, gel

Acidum azelaicum

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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any not mentioned 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 gel 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 epidermis, reduces the amount of fatty acids on the skin surface, and reduces the number of comedones.
Indications
Treatment of moderate acne on the face.

2. Important information before using Skinoren

When not to use Skinoren

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

• 6.

Warnings and precautions

Before starting to use Skinoren, you should consult a doctor or pharmacist.
You should avoid contact between the medicine and the eyes, mouth, and mucous membranes.
When using Skinoren on the face, you should be careful not to get 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 contact a doctor.
After each use of Skinoren, you should wash your hands.
After the medicine was introduced to the market, rare cases of asthma exacerbation were reported in patients treated with azelaic acid.

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

Before using any medicine, you should consult a doctor.
You should not use Skinoren during pregnancy or breastfeeding, unless your doctor recommends it.
You should avoid contact between the newborn and the skin or breasts treated with Skinoren.

Driving and using machines

Skinoren does not affect the ability to drive or use machines.

Important information about some 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 used only on the skin.
Before using 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 recommends otherwise, a thin layer of the medicine is usually applied to the affected areas of the skin twice a day, in the morning and evening. The medicine should be gently rubbed in.
A strip of gel squeezed from the tube, about 2.5 cm long (about 0.5 g), is enough to cover the face.
After applying the medicine, you should wash your hands.
You should not use occlusive dressings on the area where the medicine is applied.
The duration of treatment with Skinoren varies from person to person and depends on the severity of the affected areas of the skin.
It is very important to use the gel regularly throughout the treatment period.
A noticeable improvement is usually seen after about 4 weeks of regular use of the medicine. To achieve the best treatment results, the medicine should be used regularly for several months.
If there is significant skin irritation, you should reduce the amount of medicine used or use it once a day until the irritation symptoms disappear. If necessary, you should stop the treatment for a few days.

Use in children and adolescents

The medicine can be used in adolescents (aged 12 to 18) for the treatment of moderate acne.
No dose adjustment is necessary in adolescents aged 12 to 18.
There are no data on the safety and efficacy of using the medicine 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 the symptoms of skin irritation persist 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.
Some patients using Skinoren may experience the following side effects.
Very common(may affect more than 1 in 10 people):

• itching, burning sensation, pain at the application site;

Common(may affect up to 1 in 10 people):

• dryness, rash, paresthesia (tingling, numbness) at the application site;

Uncommon(may affect up to 1 in 100 people):

• contact dermatitis, redness, skin peeling, feeling of warmth, skin discoloration at the application site; Rare (may affect up to 1 in 1000 people ):
• hypersensitivity, which may occur with one or more of the following side effects: angioedema (sudden skin swelling), eye swelling, facial swelling, shortness of breath („shortness of breath”)
• skin irritation
• urticaria
• worsening of asthma symptoms

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

Children and adolescents

Treatment of moderate acne in adolescents (aged 12 to 18)
In clinical trials, the overall frequency of side effects in adolescents was similar to that in adults.

Reporting side effects

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

5. How to store Skinoren

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 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 what the packaging contains

Skinoren is a white or yellowish-white, opaque gel.
The packaging of the medicine is an aluminum tube containing 50 g of gel, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, 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
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
Marketing authorization number in Romania, the country of export: 11426/2019/03
Parallel import authorization number: 36/22
Date of approval of the leaflet: 12.01.2022
[Information about the trademark]