Skinoren Rosacea

Leaflet attached to the packaging: patient information

Skinoren Rosacea

150 mg/g gel
Acidum azelaicum

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor or pharmacist should be informed.

Table of contents of the leaflet:

• 1. What is Skinoren Rosacea and what is it used for
• 2. Important information before using Skinoren Rosacea
• 3. How to use Skinoren Rosacea
• 4. Possible side effects
• 5. How to store Skinoren Rosacea
• 6. Package contents and other information

1. What is Skinoren Rosacea and what is it used for

Skinoren Rosacea contains azelaic acid as the active substance and is intended for topical use on the skin to treat rosacea. It is used to reduce inflammatory papules and pustules on the face.

2. Important information before using Skinoren Rosacea

When not to use Skinoren Rosacea

Warnings and precautions

Before starting to use Skinoren Rosacea, the doctor or pharmacist should be consulted.
Skinoren Rosacea is intended for topical use on the skin only. Caution should be exercised to avoid contact with the eyes, mouth, and other mucous membranes.
In case of accidental contact with the eyes, mouth, and/or mucous membranes, they should be rinsed with a large amount of water. If eye irritation persists, the doctor or pharmacist should be consulted.
After each application of Skinoren Rosacea, the hands should be washed.
Due to the high sensitivity of the skin with rosacea, during treatment with Skinoren Rosacea, it is recommended to avoid using other topical medicines and skin care products that may cause local irritation, such as soap, face cleansing products containing alcohol, medicinal tinctures, astringents, and exfoliants.
After the marketing of the medicine, rare cases of worsening asthma have been reported in patients treated with azelaic acid.
Children and adolescents
Skinoren Rosacea is not recommended for use in children and adolescents under 18 years of age, due to the lack of data on safety and efficacy in the treatment of rosacea.

Other medicines and Skinoren Rosacea

So far, there have been no reports on the impact of Skinoren Rosacea on the use of other medicines, as well as the impact of other medicines on the use of Skinoren Rosacea.
The doctor should be informed about all medicines currently being taken or recently taken, as well as medicines that the patient plans to take.

Pregnancy and breastfeeding

There are no data on the use of azelaic acid in pregnant women. In the case of pregnant or breastfeeding women, the doctor decides whether they can use Skinoren Rosacea.
Infants should not come into contact with the skin or breast treated with this medicine.
In pregnancy and during breastfeeding, or if there is a suspicion of pregnancy, or if pregnancy is planned, before using this medicine, the doctor or pharmacist should be consulted.

Driving and using machines

Skinoren Rosacea has no effect on the ability to drive vehicles and operate machines.
Skinoren Rosacea contains benzene acid and propylene glycol.
Skinoren Rosacea contains 1 mg of benzene acid in 1 g of gel. Benzene acid may cause local skin irritation.
Skinoren Rosacea contains 120 mg of propylene glycol in 1 g of gel.

3. How to use Skinoren Rosacea

Skinoren Rosacea should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted again.
Skinoren Rosacea is intended for topical use (on the skin) only.
Usual dosage and frequency of application of Skinoren Rosacea
Skinoren Rosacea should be applied to the affected areas of the skin twice a day (morning and evening) and gently rubbed into the skin. About 2.5 cm of the medicine squeezed from the tube, which corresponds to 0.5 g of gel, is sufficient to cover the entire face.
To achieve the optimal treatment result, it is important to regularly use Skinoren Rosacea throughout the entire treatment period.
In case of skin irritation (see section 4 - "Possible side effects"), the frequency of application of Skinoren Rosacea can be reduced to once a day until the irritation subsides. If necessary, treatment should be discontinued for a few days.
Method of application
Before using Skinoren Rosacea, the skin should be thoroughly cleaned with water and dried.
A mild skin cleanser can be used.
Do not use non-breathable and waterproof (occlusive) dressings and protective dressings. After applying the gel, the hands should be washed.
Duration of treatment
The doctor should inform the patient how long to use Skinoren Rosacea.
The duration of treatment with Skinoren Rosacea may vary individually and depends on the severity of skin lesions.
Skinoren Rosacea can be used for several months, depending on the efficacy of the treatment.
A noticeable improvement can be observed after 4 weeks of treatment.
If there is no improvement after 2 months of treatment or if rosacea worsens, the use of Skinoren Rosacea should be discontinued and the doctor consulted.

Using a higher dose of Skinoren Rosacea than recommended

In case of using a higher dose of Skinoren Rosacea than recommended, it is unlikely to cause harmful effects (poisoning).
In case of doubts, the medicine should be continued to be used as directed and the doctor consulted.

Missing a dose of Skinoren Rosacea

A double dose of the medicine should not be used to make up for a missed dose. Treatment should be continued as directed by the doctor.

Discontinuing the use of Skinoren Rosacea

If the use of Skinoren Rosacea is discontinued, the symptoms of the skin disease may worsen. Before discontinuing the use of Skinoren Rosacea, the doctor should be consulted.
In case of any further doubts regarding the use of Skinoren Rosacea, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Skinoren Rosacea can cause side effects, although not everybody gets them.
Skin irritation (e.g., burning and itching) may occur. In most cases, the symptoms of irritation are mild or moderate. The frequency of their occurrence decreases with the duration of treatment.
The most commonly observed side effects are itching (pruritus), burning, and pain at the application site.
During treatment with Skinoren Rosacea, the following side effects may occur, which affect the skin at the application site:
Very common (may occur more often than in 1 in 10 people):burning, pain, itching (pruritus) at the application site;
Common (may occur no more often than in 1 in 10 people):feeling of tingling or numbness (paresthesia), dryness of the skin, rash, swelling (edema) at the application site;
Uncommon (may occur no more often than in 1 in 100 people):acne, skin reaction to an external factor (contact dermatitis), unnatural redness of the face (erythema), urticaria, feeling of discomfort at the application site;

Rare (may occur no more often than in 1 in 1000 people) :

• Hypersensitivity, which may occur with one or more of the following side effects: angioedema (sudden skin swelling), eye swelling, facial swelling, shortness of breath ("short breath")
• Skin irritation
• Urticaria
• Worsening of asthma symptoms

In clinical trials in patients treated with azelaic acid in the form of a gel for acne, a change in skin pigmentation at the application site was observed, whereas it was not observed in patients treated for rosacea, although it cannot be ruled out (frequency not known).

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Skinoren Rosacea

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "EXP".
The expiry date refers to the last day of the given month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Skinoren Rosacea contains

• The active substance of Skinoren Rosacea is azelaic acid. 1 g of Skinoren Rosacea contains 150 mg of azelaic acid.

Other ingredients are: benzene acid (E210), carbomer 980, disodium edetate, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and triglycerides of saturated fatty acids of medium chain length

What Skinoren Rosacea looks like and what the package contains

Skinoren Rosacea is a white or yellowish-white, opaque gel.
The package of Skinoren Rosacea is an aluminum tube containing 30 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21

• I- 20090 Segrate (Milan) Italy

For more detailed information, please contact the marketing authorization holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: 22 244 18 40
This medicine is authorized for marketing in the countries of the European Economic Area under the following names:
Austria, Netherlands, Estonia, Latvia, Lithuania, Slovakia - Finacea
Poland - Skinoren Rosacea.
Date of last revision of the leaflet:March 2021