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 the entire 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 or pharmacist.
- 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 identical.
- If any adverse reactions occur in the patient, including any adverse reactions 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 available as a topical cream.
The active substance is azelaic acid, which has antibacterial properties (inhibits the growth of Propionibacterium acnes bacteria), reduces excessive keratinization of the epidermis, decreases 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 epidermal pigment cells (melanocytes).
Indications
Treatment of acne vulgaris and skin hyperpigmentation.
2. Important information before using Skinoren medicine
When not to use Skinoren
Do not use Skinoren if the patient has hypersensitivity (allergy) 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 medicine with eyes, mouth, and mucous membranes.
When applying Skinoren to the facial skin, take care to prevent the medicine from entering the eyes.
If the medicine comes into contact with eyes, mouth, or mucous membranes, 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 have not been established in children under 12 years of age.
Skinoren and other medicines
Inform your doctor about all medicines you are currently taking or have 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 a breastfed infant and the skin or breasts treated with Skinoren.
Consult a doctor or pharmacist if you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, before using this medicine.
Driving and operating machinery
Skinoren has no effect 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 cetearyl alcohol and may therefore cause local skin reactions (e.g. contact dermatitis).
3. How to use Skinoren
Skinoren should be used as directed by the physician. In case of doubt, consult the doctor or pharmacist again.
Skinoren is for external use only. Before applying Skinoren, the skin should be thoroughly washed with plain water and dried. A mild skin-cleansing product may also be used.
Unless otherwise prescribed by the physician, a thin layer of cream should usually be applied to the affected skin twice daily – in the morning and evening. The cream should be gently rubbed in. 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. To achieve optimal treatment results, the medication 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 at least 3 months. Best results are achieved with consistent, regular use. Since sunlight exposure may worsen skin pigmentation, 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 medication 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 are no data on the safety and efficacy of Skinoren in children under 12 years of age.
If the effect of the medication seems too strong or too weak, consult a doctor.
Discontinuation of Skinoren treatment
If skin irritation persists during treatment with Skinoren, treatment should be discontinued for several days.
4. Possible adverse reactions
Like any medicine, Skinoren may cause adverse reactions, although not everyone experiences them.
Skin irritation may occur at the beginning of treatment.
The list of adverse reactions below is based on reports from clinical trials and spontaneous reports resulting from post-marketing safety monitoring. The adverse reactions listed below are arranged according to frequency of 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):
- seborrhoeic dermatitis, acne, skin discoloration, paraesthesia (pricking, tingling sensation), dermatitis, discomfort, swelling at the application site;
Rare (may affect up to 1 in 1000 people):
- Hypersensitivity to medicines (which may manifest as one of the following adverse reactions: angioedema, contact dermatitis, eye swelling, facial swelling), worsening of asthma symptoms, urticaria, cheilitis, rash, stinging, 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 those not listed in this leaflet, inform your doctor or pharmacist. 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, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of further information on the safety of the medicine.
5. How to store Skinoren
Do not store above 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.
The shelf-life after first opening of 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 packaging and other information
What the medicine 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 stearates.
What Skinoren looks like and contents of the pack
Skinoren is a white cream. It is supplied in an aluminium tube with an internal epoxy resin
coating and a polyethylene cap, packed in a cardboard box containing 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Austrian Marketing Authorisation Number (country of export): 1-18823
Parallel Import Licence Number: 279/24