Skinoren
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Skinoren
200 mg/g (20%), cream
Acidum azelaicum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents:
- 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 presented as a topical cream.
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 proliferation and hyperactivity 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 any of the other ingredients of Skinoren (see section 6).
Warnings and precautions
Before starting treatment with Skinoren, consult a doctor or pharmacist.
Avoid contact of the medicinal product with eyes, mouth, and mucous membranes.
When applying Skinoren to facial skin, take care to prevent the product from entering the eyes.
If Skinoren comes into contact with the eyes, mouth, or mucous membranes, rinse immediately with a large amount of water. If eye irritation persists, the patient should contact a doctor.
Hands should be washed after each application of Skinoren.
Children and adolescents
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The safety and efficacy of Skinoren have not been established in children under 12 years of age.
Skinoren and other medicinal products
Inform your doctor about all medicinal products you are currently using or have 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 between the breastfed infant and skin treated with Skinoren or the breasts.
Consult a doctor or pharmacist if you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, before using this medicinal product.
Driving and operating machinery
Skinoren has no influence on the ability to drive or operate machinery.
Important information about certain 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 cetostearyl alcohol, which may 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 external use only. Before applying Skinoren, wash the skin thoroughly with plain water and dry it. You may also use a mild cleansing product suitable for skin cleansing.
Unless otherwise directed by your doctor, a thin layer of cream should usually be applied to the affected skin twice daily – in the morning and evening. Gently rub the cream into the skin. A strip of cream squeezed from the tube approximately 2.5 cm long (about 0.5 g) is sufficient for the entire face. After application, wash your hands.
The duration of treatment with Skinoren varies between individual patients and depends on the severity of the skin condition.
In the treatment of acne vulgaris, noticeable improvement is usually seen after approximately 4 weeks of regular use. For optimal treatment results, Skinoren should be used regularly for several months, up to a maximum of 12 months.
For the treatment of skin pigmentation disorders, Skinoren is recommended for use for at least 3 months. Best results are achieved with consistent, regular use. Since sunlight exposure may worsen pigmentation disorders, sunscreen products containing both UV B and UV A filters should be used throughout the entire treatment period.
If significant skin irritation occurs, reduce the amount of cream applied or apply it once daily until symptoms of irritation subside. If necessary, discontinue treatment for several days.
Use in children and adolescents
Skinoren may 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 that the effect of this medicine is too strong or too weak, you should consult your doctor.
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Discontinuation of Skinoren
If skin irritation persists during treatment with Skinoren, discontinue treatment for several days.
4. Possible adverse reactions
Like all medicines, Skinoren may cause adverse reactions, although not everyone will experience them.
At the beginning of treatment, skin irritation may occur.
The list below is based on reports from clinical trials and spontaneous reports resulting from post-marketing safety monitoring. The adverse reactions listed below are categorized according to 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 (prickling, tingling sensation), dermatitis, sensation of discomfort, swelling at the application site;
Rare (may occur in 1 in 1000 people):
- Hypersensitivity to the medicine (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 Adverse Drug Reactions of 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 medicine.
5. How to store Skinoren
Do not store above 30°C.
Keep in a place invisible and inaccessible to 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.
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Shelf-life after first opening the immediate packaging: 6 months.
Medicines must 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 packaging and other information
What Skinoren contains
The active substance is azelaic acid.
Each 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, cetostearyl alcohol, propylene glycol,
purified water, macrogol glyceryl stearate.
What Skinoren looks like and contents of the pack
Skinoren is a white cream. The aluminium tube contains 30 g of cream.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
LEO Pharma A/S, Industriparken 55, 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
Austrian Marketing Authorisation number (country of export): 1-18823
Parallel Import Authorisation number: 149/24
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