Skinoren
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep 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, as you may need to read it again.
- 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 any not listed in this leaflet, inform your doctor or pharmacist. 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 medicine 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), inhibits 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 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, care should be taken to prevent the product from entering the eyes.
If contact with eyes, mouth, or mucous membranes occurs, rinse immediately 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 medicinal products you are currently taking or have recently taken, 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 the skin or breasts treated with Skinoren.
Consult a doctor or pharmacist before using this medicinal product if you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy.
Driving and operating machinery
Skinoren has no influence on the ability to drive or operate machinery.
Important information about certain ingredients of Skinoren
Skinoren contains 2 mg of benzoic acid per 1 g of cream. Benzoic acid may cause local skin irritation.
Skinoren 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 gentle skin-cleansing product.
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 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 between individuals 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, Skinoren should be used 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 exposure may worsen pigmentation, sunscreen products protecting against both UV B and UV A radiation should be used throughout the entire treatment period.
If significant skin irritation occurs, reduce the amount of medication applied or apply 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 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 use for several days.
4. Possible adverse reactions
Like any medicine, 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 following post-marketing safety monitoring. The adverse reactions listed below are categorized according to their frequency and 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, feeling 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, eczema, ulceration at the application site. The above-mentioned adverse reactions were reported after Skinoren was authorized for marketing.
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 any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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
Store below 30°C.
Keep the medicine out of the 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 must 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 package 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%, glycerol 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 cream is supplied in an aluminum tube with a polyethylene cap, containing 30 g of cream, packed in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, country of export: 20000455
Parallel Import Authorisation Number: 112/20