Skinoren
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Skinoren
200 mg/g, cream
Acidum azelaicum
Please read the following 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 pass it on to others. The medicine may harm others, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:
- What is Skinoren and what is it used for
- Important information before using Skinoren
- How to use Skinoren
- Possible side effects
- How to store Skinoren
- Contents of the package and other information
1. What is Skinoren and what is it 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 activity (inhibits the growth of Propionibacterium acnes bacteria), 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 the facial skin, care must be taken to prevent the product from entering the eyes.
If contact with 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 have not been established in children under 12 years of age.
Skinoren and other medicines
Inform your doctor about all medicines currently used or recently used, 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 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 some 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 doubts, consult your doctor or pharmacist again.
Skinoren should be applied to the skin only. Before applying Skinoren, thoroughly wash the skin with plain water and dry it. A mild skin cleansing product may also be used.
Unless otherwise prescribed by a 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 in length (about 0.5 g) is sufficient for the entire face. Hands should be washed after application.
The duration of treatment with Skinoren varies between 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.
In the treatment of skin hyperpigmentation, Skinoren is recommended for use for at least 3 months. Best results are achieved with consistent, regular use. Since solar radiation may worsen skin 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 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 use in children under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Discontinuation of Skinoren treatment
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 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 following safety monitoring of the medicine after its marketing authorization. The adverse reactions listed below are categorized according to their 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): -
Seborrheic dermatitis, acne, skin discoloration, paresthesia (pricking, tingling sensation), dermatitis, 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, 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 your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 helps to provide more information on the safety of the medicine.
5. How to store Skinoren medicine
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 container. 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 required. 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, glycerol 85%, glyceryl stearate + cetostearyl alcohol + cetyl palmitate + macrogol glycerides from coconut (CUTINA CBS), propylene glycol, purified water, macrogol stearates of glyceryl.
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 responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Marketing Authorisation Number in Romania, the country of export: 11427/2019/01
Parallel Import Licence Number: 173/19