Skinoren
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Skinoren
150 mg/g, gel
Azelaic acid
Please read the following information 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 pass it on to others. This medicine may harm other people, 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 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 in the form of a topical gel.
The active substance is azelaic acid, which has antibacterial properties (inhibits the growth of Propionibacterium acnes), reduces excessive keratinization of the epidermis, decreases the amount of fatty acids on the skin surface, and reduces the number of comedones.
Indications
Treatment of mild to moderate facial papulopustular acne.
2. Important information before using Skinoren
When not to use Skinoren
Do not use Skinoren if the patient is allergic (hypersensitive) to azelaic acid or to any of the other ingredients of Skinoren (listed in 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 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.
After marketing, exacerbation of asthma has rarely been reported in patients treated with azelaic acid.
Children and adolescents
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 taking or have recently taken, including those available without a prescription.
No studies on interactions have been conducted.
Pregnancy, breastfeeding, and fertility
Before using any medicinal product, consult a doctor.
Do not use Skinoren during pregnancy or breastfeeding unless advised by a doctor.
Avoid contact of the newborn with skin areas treated with Skinoren or with the breasts if they are being treated.
Driving and operating machinery
Skinoren has no influence on the ability to drive or operate machinery.
Important information about some ingredients of Skinoren
Skinoren gel contains 1 mg of benzoic acid per 1 g of gel. Benzoic acid may cause local skin irritation.
Skinoren gel contains 120 mg of propylene glycol per 1 g of gel.
3. How to use Skinoren
Skinoren should be applied to the skin 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 directed by a physician, a thin layer of the medicinal product should usually be applied to the affected areas of the skin twice daily – in the morning and evening.
The product should be gently rubbed in. A strip of gel squeezed from the tube, approximately 2.5 cm long (about 0.5 g), is sufficient to cover the entire facial skin.
Hands should be washed after applying the product.
Occlusive (sealed) dressings must not be used on the area where the product has been applied.
The duration of treatment with Skinoren varies between individual patients and depends on the severity of the affected skin areas.
Regular use of Skinoren throughout the entire treatment period is very important.
Noticeable improvement is usually achieved after approximately 4 weeks of consistent use. For optimal treatment results, the product should be used regularly for several months.
If significant skin irritation occurs, the amount of product used should be reduced or it should be applied once daily until symptoms of irritation subside. If necessary, treatment should be interrupted for several days.
Use in children and adolescents
The product can be used in adolescents (aged 12 to 18 years) for the treatment of papulopustular acne. 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 symptoms of irritation persist 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.
The following adverse symptoms may occur in some patients using Skinoren.
Very common (may occur in more than 1 in 10 people):
- itching, burning sensation, pain at the application site.
Common (may occur in 1 in 10 people):
- dryness, rash, paraesthesia (pricking, tingling sensation) at the application site.
Uncommon (may occur in 1 in 100 people):
- contact dermatitis, erythema, skin desquamation, sensation of warmth, skin discolouration at the application site.
Rare (may occur in no more than 1 in 1000 people):
- hypersensitivity, which may present with one or more of the following adverse reactions: angioedema (sudden swelling of the skin), eye swelling, facial swelling, dyspnoea (shortness of breath)
- skin irritation
- urticaria
- worsening of asthma symptoms.
Additional adverse reactions have been reported during post-marketing use of medicinal products containing azelaic acid. If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.
Children and adolescents
Treatment of papulopustular acne in adolescents (aged 12 to 18 years)
In clinical trials, the overall incidence of adverse reactions in adolescents included in the studies was similar to that in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 181C, 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
Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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.
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.
1 g of gel contains 150 mg of azelaic acid.
The other ingredients are: propylene glycol, polysorbate 80, lecithin, carbomers, medium-chain triglycerides,
sodium hydroxide, disodium edetate, benzoic acid, purified water.
What Skinoren looks like and contents of the pack
Skinoren is a white or yellowish-white, opaque gel.
The pack contains an aluminium tube with 50 g of gel, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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
20090 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 Romania, country of export: 11426/2019/03
Parallel import authorisation number: 360/22