Package leaflet: Information for the patient

Warning! Please retain this leaflet. The information on the immediate packaging is in a foreign language.
Skinoren
200 mg/g, cream
Acidum azelaicum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Skinoren is and what it is used for
Important information before using Skinoren
How to use Skinoren
Possible side effects
How to store Skinoren
Contents of the pack and other information

1. What Skinoren is and what it is used for

Skinoren is an anti-acne medication in the form of a cream for topical application.
The active substance is azelaic acid, which has antibacterial properties (inhibits the growth of Propionibacterium acnes), suppresses excessive keratinization of the epidermis, reduces the amount of free fatty acids on the skin surface, and decreases the number of comedones. Additionally, azelaic acid inhibits the growth and excessive activity of abnormal epidermal pigment cells (melanocytes).
Indications
Treatment of acne vulgaris and skin pigmentation disorders.

2. Important information before using Skinoren

When not to use Skinoren
Do not use Skinoren if the patient is allergic (hypersensitive) to azelaic acid, propylene glycol, or to any of the other ingredients of Skinoren (see section 6).

Warnings and precautions
Before starting to use Skinoren, consult a doctor or pharmacist.
Avoid contact of the medicinal product with the eyes, mouth, and mucous membranes.
When applying Skinoren to the facial skin, care should be taken to prevent the product from entering the eyes.
If contact with the eyes, mouth, or mucous membranes occurs, immediately rinse thoroughly with plenty of water. If eye irritation persists, the patient should contact a doctor.
Hands should be washed after each application of Skinoren.

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

Skinoren and other medicinal products
Inform your doctor about all medicines currently used or recently used, including those available without a prescription. No studies on interactions have been conducted.

Pregnancy, breastfeeding, and fertility
Do not use Skinoren during pregnancy or breastfeeding unless advised by a doctor.
Avoid contact of the breastfed infant with skin treated with Skinoren or with the breasts.
Consult a doctor or pharmacist if a woman is pregnant, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, before using this medicinal product.

Driving and operating machinery
Skinoren has no influence on the ability to drive and operate machinery.

Important information about certain excipients in 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 cetostearyl alcohol and may therefore cause local skin reactions (e.g. contact dermatitis).

3. How to use Skinoren

Use Skinoren exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
Skinoren is for topical use only. Before applying Skinoren, wash the skin thoroughly with plain water and dry it. You may also use a mild skin-cleansing product.
Unless otherwise directed by your doctor, a thin layer of cream should usually be applied twice daily—morning and evening—on the affected skin areas. Gently rub in the cream. A strip of cream squeezed from the tube approximately 2.5 cm long (about 0.5 g) is sufficient for the entire face. Hands should be washed after applying the medication.
The duration of treatment with Skinoren varies among individual patients and depends on the severity of skin lesions.

In the treatment of acne vulgaris, noticeable improvement is usually observed after approximately 4 weeks of regular use. For optimal treatment results, continue using the medication regularly for several months, up to a maximum of 12 months.

For the treatment of skin pigmentation disorders, Skinoren should be used for at least 3 months. Best results are achieved with consistent, regular use. Since sunlight may worsen skin pigmentation, it is essential to use creams with both UV B and UV A filters throughout the entire treatment period.

If significant skin irritation occurs, reduce the amount of medication applied or use it once daily until symptoms of irritation subside. If necessary, discontinue treatment for several days.

Use in children and adolescents
Skinoren can be used in adolescents (aged 12 to 18 years) for the treatment of acne vulgaris. Dose adjustment in adolescents aged 12 to 18 years is not required.
There is insufficient data on the safety and efficacy of Skinoren in children under 12 years of age.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Discontinuation of Skinoren
If skin irritation persists during treatment with Skinoren, discontinue treatment for several days.

4. Possible adverse reactions

Like any medicinal product, Skinoren may cause adverse reactions, although not everyone experiences them.
At the beginning of treatment, skin irritation may occur.
The list below is based on reports from clinical trials and spontaneous reports collected during post-marketing safety monitoring. The adverse reactions listed below are categorized according to their frequency of occurrence.

Very common (may occur in more than 1 in 10 people):

Itching, burning sensation, redness at the application site

Common (may occur in 1 in 10 people):

Skin peeling, pain, dryness, skin discoloration, irritation at the application site

Uncommon (may occur in 1 in 100 people):

Seborrhoeic dermatitis, acne, skin discoloration, paraesthesia (pricking, tingling sensation), dermatitis, discomfort, swelling at the application site

Rare (may occur in 1 in 1000 people):

Hypersensitivity to the medicinal product (which may manifest as one of the following adverse reactions: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, burning, blisters, eruption, ulceration at the application site

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Skinoren

Store below 30°C, in the original packaging.
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 stated month.
Shelf-life after first 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 in use. 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 cream contains 200 mg of azelaic acid.
The other ingredients are: benzoic acid (E 210), cetearyl octanoate + isopropyl myristate
(PCL Liquid), glycerol 85%, glyceryl monostearate 40-55, cetostearyl alcohol, propylene glycol, purified water, macrogol glyceryl stearates.

What Skinoren looks like and contents of the pack
Skinoren is a white cream. The aluminium tube contains 30 g of cream.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in Romania, country of export: 11427/2019/01
Parallel import authorisation number: 342/17