Skinoren

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Skinoren, 200 mg/g (20%), cream

Azelaic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your 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. 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 cream for application to the skin.
The active substance of the medicine is azelaic acid, which has antibacterial properties (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 you are allergic (hypersensitive) to azelaic acid, propylene glycol, or any of the other ingredients of Skinoren (see section 6).

Warnings and precautions

Before starting to use Skinoren, consult your doctor or pharmacist.
Avoid contact of the medicine with the eyes, mouth, and mucous membranes.
When using Skinoren on the face, be careful not to get the medicine in the 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.

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 conducted.

Pregnancy, breastfeeding, and fertility

Do not use Skinoren during pregnancy and breastfeeding, unless your doctor advises you to do so.
Avoid contact between the child being breastfed and the skin or breasts treated with Skinoren.
Consult your doctor or pharmacist if you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant before using this medicine.

Driving and using machines

Skinoren has no influence 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.

3. How to use Skinoren

Use Skinoren as directed by your doctor. If you are unsure, consult your doctor or pharmacist again.
Use Skinoren only on the skin. Before applying Skinoren, wash the skin thoroughly with plain water and dry. You can also use a mild skin cleanser.
Unless your doctor advises otherwise, apply a thin layer of cream to the affected skin twice a day, in the morning and evening. Gently rub in the cream. A strip of cream about 2.5 cm long (about 0.5 g) is enough for the face. After applying the medicine, 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 usually seen after about 4 weeks of regular use of the medicine. To achieve the best treatment results, 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, use sunscreens with UVB and UVA filters during the entire treatment period.
If significant skin irritation occurs, reduce the amount of medicine used or apply it once a day until the irritation symptoms subside. If necessary, discontinue treatment for a few days.

Use in children and adolescents

Use the medicine in adolescents (12-18 years old) for the treatment of common acne. Dose adjustment is not necessary in adolescents (12-18 years old).
There are no data on the safety and efficacy of use in children under 12 years old.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Discontinuation of Skinoren

If skin irritation persists during the use of Skinoren, discontinue 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 from post-marketing surveillance of the medicine. The listed side effects are ordered by 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. These side effects have been reported after the marketing authorization of Skinoren cream.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Skinoren

Store 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 opening the immediate packaging: 6 months.
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 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, glycerol 85%, Cutina CBS (glycerol stearate, cetyl alcohol, cetyl palmitate, trialkylglycerol (C12-C18) 7:1:1:1), propylene glycol, macrogol stearate, purified water.

What Skinoren looks like and contents of the pack

Skinoren is a white cream.
An aluminum tube containing 30 g of cream.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, 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, I-20090 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 Greece, the country of export:
6914/2-2-2006
39559/10/25-4-2011
103338/28-11-2019

Parallel import authorization number: 89/11

Date of leaflet approval: 18.06.2024

[Information about the trademark]