SKINOREN creme 20% 30g
Leaflet: patient information
Skinoren 20% cream
Azelaic acid
Skinoren® 20% cream
Azelaic acid
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
What this leaflet contains
1. What Skinoren is and what it is used for
2. What you need to know before you use Skinoren
3. How to use Skinoren
4. Possible side effects
5. How to store Skinoren
6. Contents of the package and additional information
1. What Skinoren is and what it is used for
Skinoren cream is a medicinal product against acne (inflammatory and non-inflammatory forms of acne). It attacks the bacteria that play an essential role in causing acne. It also suppresses the growth of rough and scaly skin cells that clog pores and cause blackheads and whiteheads.
Skinoren cream is also used to treat melasma. It suppresses the growth and viability of abnormal melanocytes, the cells that cause skin pigmentation known as melasma.
2. What you need to know before you use Skinoren
Do not use Skinoren
- if you are allergic to azelaic acid or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using Skinoren.
- Skinoren cream is for external use only
- if you apply Skinoren, it should be done only on the affected parts of the skin
- if you apply Skinoren to your face, there should be no contact with the eyes, mouth and mucous membranes. In case of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed thoroughly with water. If eye irritation persists, patients should consult a physician. Hands should be washed after each application of Skinoren cream.
2
Skinoren cream contains 125 mg of propylene glycol in each g.
Skinoren cream contains 2 mg of benzoic acid in each g. Benzoic acid may cause local irritation.
Skinoren cream contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).
- Certain types of melasma (epidermal and mixed epidermal-dermal types) respond well to Skinoren cream. In contrast, the pure dermal type of melasma is not affected.
Worsening of asthma symptoms has been rarely reported in patients with asthma treated with azelaic acid.
Other medicines and Skinoren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
No studies have been conducted with Skinoren cream in pregnant women. Results of studies with Skinoren cream on reproduction in animals indicate a potential for reactions when used during pregnancy. However, no effects were observed in animals at doses at least 3 to 32 times the maximum recommended human dose.
Breastfeeding
The active substance of this medicine (azelaic acid) can pass into breast milk in very small amounts. In any case, the amount of the active substance that your baby would receive daily with breast milk would be very small and pose no risk, especially considering the extremely low toxicity of this active substance.
Administration of Skinoren cream to nursing women should be carried out with caution.
Infants should not come into contact with the treated skin/breast.
Driving and using machines
Skinoren cream does not affect the ability to drive and operate machinery.
Skinoren contains propylene glycol, benzoic acid and cetostearyl alcohol
The medicinal product contains propylene glycol as an excipient, which may cause skin irritation. Benzoic acid is a moderate irritant to the skin, eyes and mucous membranes.
Cetostearyl alcohol may cause local skin reactions (eg contact dermatitis).
3. How to use Skinoren
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The following applies to Skinoren cream, unless your doctor has prescribed otherwise.
Please follow the instructions for use in order to achieve the maximum result of treatment with Skinoren cream.
3
Before using Skinoren cream, the skin should be washed well with clean water and dried. A mild detergent can also be used. Before applying Skinoren, the skin must be completely dry.
The recommended dose is:
Skinoren cream should be applied to the affected areas twice a day (morning and evening) by gently rubbing into the skin. Approximately 2.5 cm is enough for the whole face.
In case of excessive skin irritation (see the section on Possible side effects), you can temporarily reduce the amount of cream applied or apply Skinoren cream only once a day until the irritation passes, or interrupt the treatment temporarily for several days, if necessary .
The duration of Skinoren cream application varies for different patients and depends on the initial severity of the skin damage. It is important to continue using Skinoren regularly throughout the treatment period.
In general, with acne, improvement is noticed after about 4 weeks. In order to have a maximum effect, Skinoren cream must be applied regularly for several months. There is clinical experience of long-term use for a period of up to one year.
For melasma, the minimum treatment period is about 3 months, and to obtain optimal results, its use should last longer. Concomitant use of sunscreens with broad spectrum (UVB and UVA) protection during the entire treatment period is mandatory, in order to avoid deterioration caused by sun exposure and/or re-pigmentation of lightened areas.
If you think that the effect of Skinoren cream is too strong or too weak, contact your doctor or pharmacist.
Use in children and adolescents
Use in adolescents (12-18 years old). No dosage adjustment is necessary for adolescents aged 12-18 years using Skinoren Cream.
The safety and efficacy of Skinoren cream in children under 12 years of age has not been established.
If you have used more than the required dose of Skinoren
Do not worry. There will be no consequences from a single overdose (when the cream is applied once on a larger part of the skin) or from accidental ingestion.
If you forget to use Skinoren
Do not increase the amount of Skinoren cream to make up for a missed dose.
If you have stopped using Skinoren
In order for the treatment to be successful, it is important to use Skinoren cream for the entire period of time for which it is prescribed. If you use Skinoren Cream as prescribed, your symptoms should go away during treatment. If your symptoms do not go away or reappear after the end of treatment, contact your doctor.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Skinoren Cream can cause side effects, although not everybody gets them.
4
The most commonly observed side effects include burning at the application site, itching at the application site, and redness at the application site. Usually, symptoms of skin irritation are mild and disappear during the course of treatment.
The following adverse reactions are based on clinical trial reports and post-marketing observations with Skinoren Cream. Adverse reactions are listed according to frequency of occurrence.
Very common: may affect more than 1 in 10 people
• burning at the site of application
• application site pruritus (itching)
• application site erythema (redness)
Common: may affect up to 1 in 10 people
• peeling at the site of application
• pain at the site of application
• dryness of the skin at the site of application
• skin discoloration at the site of application
• irritation at the site of application
Uncommon: may affect up to 1 in 100 people
• seborrhea (excessively oily skin)
• acne
• skin depigmentation (lightening)
• application site paresthesia (numbness, tickling, stinging, goosebumps or burning sensation)
• application site dermatitis
• discomfort at the site of application
• edema at the application site (swelling)
Rare: may affect up to 1 in 1,000 people
• hypersensitivity to the medicinal substance (can be manifested by angioedema 1, contact dermatitis 1, swelling of the eyes 1, swelling of the face 1)
• worsening of asthma
• urticaria 1
• cheilitis (inflammation of the lips)
• rash 1
• heat at the application site
• application site vesicles (small, fluid-filled blisters)
• rash at the site of application
• wounding at the site of application
1 These side effects have been reported in patients using Skinoren cream after its approval for use
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
Additional adverse reactions in children and adolescents
Clinical studies involving adolescents aged 12-18 years (454/1336; 34%) showed that the local tolerability of Skinoren Cream was similar in pediatric and adult patients.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Medicines Executive Agency, 8 Damyan Gruev St.
1303 Sofia, phone: +359 2 8903417, website: www.bda.bg.
5
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Skinoren
Keep out of the reach of children.
To be stored at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date corresponds to the last day of the specified month.
The shelf life after first opening the tube is 6 months.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Skinoren contains
- The active substance is: azelaic acid. 1 g of cream contains 200 mg (20%) azelaic acid.
- The other ingredients are: benzoic acid (E210), cetearyl octanoate + isopropyl myristate (PCL Liquid®), glycerol 85%, propylene glycol, purified water, macrogolglycerides stearates, glycerol monostearate 40-55, cetostearyl alcohol.
What Skinoren looks like and contents of the pack
Skinoren cream is available in tubes containing 30 g of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
Manufacturer:
LEO Pharma Manufacturing Italy Srl
Via E. Schering 21
20054 Segrate (Milan), Italy
Date of last revision of the leaflet 04/2023
