Skinoren

Package Leaflet: Information for the Patient

Skinoren, 150 mg/g, gel
(Azelaic Acid)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 skin, 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 you are allergic (hypersensitive) to azelaic acid or any of the other ingredients of Skinoren (listed in section 6).

• 6).

Warnings and precautions

Before using Skinoren, consult your doctor or pharmacist.
Avoid contact with the eyes, mouth, and mucous membranes.
When using Skinoren on the face, be careful not to get the medicine in your eyes.
If the medicine comes into contact with the eyes, mouth, or mucous membranes, rinse them immediately with plenty of water.
If eye irritation persists, the patient should consult a doctor.
After each use of Skinoren, wash your hands.
Rarely, exacerbation of asthma has been reported in patients treated with azelaic acid.

Children and adolescents

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

Skinoren and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
No interaction studies have been performed.

Pregnancy, breastfeeding, and fertility

Before using any medicine, consult your doctor.
Do not use Skinoren during pregnancy or breastfeeding, unless your doctor has advised you to do so.
Avoid contact between the newborn and the skin or breasts treated with Skinoren.

Driving and using machines

Skinoren has no effect on the ability to drive or operate machinery.

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, wash your skin with ordinary water and dry it. You can also use a mild skin cleanser.
Unless otherwise advised by your doctor, apply a thin layer of the medicine to the affected areas of the skin twice a day, in the morning and evening. Gently rub in the medicine. A strip of gel about 2.5 cm long (about 0.5 g) is enough to cover the face.
After applying the medicine, wash your hands.
Do not use occlusive dressings on the area where the medicine is applied.
The duration of treatment with Skinoren varies from patient to patient and depends on the severity of the skin lesions.
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 results, the medicine should be used regularly for several months.
If there is significant skin irritation, reduce the amount of medicine used or use it once a day until the irritation symptoms subside. If necessary, stop treatment for a few days.

Use in children and adolescents

The medicine can be used in adolescents (12 to 18 years old) for the treatment of moderate acne.
No dose adjustment is necessary in adolescents (12 to 18 years old).
There are no 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.

Stopping Skinoren treatment

If skin irritation persists during treatment with Skinoren, stop treatment for a few days.

4. Possible side effects

Like all medicines, Skinoren can cause side effects, although not everybody gets them.
The following side effects may occur in patients using Skinoren:
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 exfoliation, 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 swelling of the skin), eye edema, facial edema, dyspnea (shortness of breath)
• Skin irritation
• Urticaria
• Worsening of asthma symptoms

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Children and adolescents

Treatment of moderate acne in adolescents (12 to 18 years old)
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 those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Skinoren

Keep out of the 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.
Medicines should 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 gel contains 150 mg of azelaic acid.
The other ingredients are: propylene glycol, polysorbate 80, soybean lecithin, carbomer 980, triglycerides of saturated fatty acids of medium chain length, sodium hydroxide, disodium edetate, benzoic acid, purified water

What Skinoren looks like and contents of the pack

Skinoren is a white or yellowish-white, opaque gel.
The pack contains an aluminum tube with 30 g or 50 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

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
To obtain more detailed information, please contact the representative of the marketing authorization holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40
Date of last revision of the leaflet:March 2021