Skinoren
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Skinoren (Ski-noren)
200 mg/g (20%), cream
Azelaic acid
Skinoren and Скинорен are the same trade names of the same medicinal product written in Polish and Bulgarian, respectively.
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, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on 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
- What you need to know 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 topical cream.
The active substance is azelaic acid, which has antibacterial activity (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 hyperactivity of abnormal epidermal pigment cells (melanocytes).
Indications
Treatment of acne vulgaris and skin hyperpigmentation.
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
Consult a doctor or pharmacist before starting treatment with Skinoren.
Avoid contact of the medicinal product with eyes, mouth, and mucous membranes.
When applying Skinoren to the facial skin, care should be taken to prevent the product from entering the eyes.
In case of contact with 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
The safety and efficacy of Skinoren have not been established in children under 12 years of age.
Skinoren and other medicines
Inform your doctor about all medicines currently taken or recently taken, including those obtained 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, 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 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 cleanser.
Unless otherwise directed by your doctor, a thin layer of cream should usually be applied twice daily – in the morning and evening – to the affected areas of skin. 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 individual patients and depends on the severity of the skin condition.
In the treatment of acne vulgaris, noticeable improvement is usually observed after approximately 4 weeks of regular use. To achieve 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 providing protection 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 that the effect of this medicine is too strong or too weak, consult your doctor.
Discontinuation of Skinoren treatment
If skin irritation persists during treatment with Skinoren, treatment should be interrupted for several days.
4. Possible adverse reactions
Like all medicines, Skinoren may cause adverse reactions, although not everyone experiences them.
Skin irritation may occur at the beginning of treatment.
The list below is based on reports from clinical trials and spontaneous reports following safety monitoring after marketing authorization of the medicine. The adverse reactions listed below are categorized according to frequency of reporting 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 (pricking, tingling sensation), dermatitis, feeling of discomfort, swelling at the application site;
Rare (may occur in 1 in 1000 people):
- Hypersensitivity reactions (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, exanthema, ulceration at the application site.
The adverse reactions listed above were reported after marketing authorization of Skinoren cream.
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 adverse reactions 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 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 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 sewage systems 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 the medicinal product 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, macrogolglycerides stearates.
What Skinoren looks like and contents of the pack
Skinoren is a white cream.
Aluminium tube with a polyethylene cap containing 30 g of cream.
For further information, please contact the responsible party or the parallel importer.
Responsible party 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Bulgaria, country of export, marketing authorization number: 20000455
Parallel import authorization number: 126/21