Skinoren rosacea
Poland
Table of Contents
Package leaflet: Information for the patient
Skinoren Rosacea
150 mg/g gel
Acidum azelaicum
Please read this 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, ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If any side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet:
- What Skinoren Rosacea is and what it is used for
- Important information before using Skinoren Rosacea
- How to use Skinoren Rosacea
- Possible side effects
- How to store Skinoren Rosacea
- Contents of the pack and other information
1. What Skinoren Rosacea is and what it is used for
Skinoren Rosacea contains azelaic acid as the active substance and is intended for topical application to the skin in the treatment of 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
- if the patient is allergic (hypersensitive) to azelaic acid or to any of the other ingredients of Skinoren Rosacea (see section 6).
Warnings and precautions
Before starting treatment with Skinoren Rosacea, consult a doctor or
pharmacist.
Skinoren Rosacea is intended for topical use on the skin only. Care should be taken to avoid contact with the eyes, mouth, and other mucous membranes.
In case of accidental contact with the eyes, mouth, and/or mucous membranes, rinse thoroughly with plenty of water. If eye irritation persists, consult a doctor or pharmacist.
After each application of Skinoren Rosacea, wash your hands.
Due to the high sensitivity of facial skin affected by rosacea, during treatment with Skinoren Rosacea it is advisable to avoid using other topical medications and skincare products that may cause local irritation, such as soap, facial cleansers containing alcohol, medicinal tinctures, astringents, and exfoliating agents.
Rarely, after the drug was placed on the market, worsening of asthma has 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 lack of data on safety and efficacy in the treatment of rosacea.
Other medicines and Skinoren Rosacea
There are currently no reports on the effect of Skinoren Rosacea on the use of other medicines, or on the effect of other medicines on the use of Skinoren Rosacea.
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy and breastfeeding
There is no data available on the use of azelaic acid in pregnant women. In pregnant or breastfeeding women, the decision whether to use Skinoren Rosacea should be made by a doctor.
Avoid contact between the treated skin or breast and infants.
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Skinoren Rosacea has no influence on the ability to drive or operate machinery.
Skinoren Rosacea contains benzoic acid and propylene glycol.
Skinoren Rosacea contains 1 mg of benzoic acid per 1 g of gel. Benzoic acid may cause local skin irritation.
Skinoren Rosacea contains 120 mg of propylene glycol per 1 g of gel.
3. How to use Skinoren Rosacea
Always use Skinoren Rosacea exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
Skinoren Rosacea is intended for topical use only (on the skin).
Recommended dosage and frequency of use of Skinoren Rosacea
Apply Skinoren Rosacea to affected areas of the skin twice daily (morning and evening), gently rubbing it into the skin. Approximately 2.5 cm of product squeezed from the tube, equivalent to 0.5 g of gel, is sufficient to cover the entire face.
To achieve optimal treatment results, it is important to use Skinoren Rosacea regularly throughout the entire treatment period.
If skin irritation occurs (see section 4 – "Possible side effects"), the frequency of application may be reduced to once daily until irritation subsides. If necessary, treatment may be interrupted for several days.
Method of administration
Before applying Skinoren Rosacea, thoroughly clean the skin with water and dry it.
A mild skin cleanser may be used.
Do not use occlusive (air- and water-impermeable) dressings or protective coverings. After applying the gel, wash your hands.
Duration of treatment
Your doctor will inform you 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 may be used for several months, depending on treatment efficacy.
Noticeable improvement may be observed after 4 weeks of treatment.
If no improvement is seen after 2 months of treatment, or if rosacea worsens, discontinue use of Skinoren Rosacea and contact your doctor.
Use of more than the recommended dose of Skinoren Rosacea
Harmful effects (poisoning) following an overdose of Skinoren Rosacea are unlikely.
If in doubt, continue using the medicine as directed and consult your doctor.
Missed dose of Skinoren Rosacea
Do not use a double dose to make up for a missed dose. Continue treatment as directed by your doctor.
Stopping treatment with Skinoren Rosacea
If treatment with Skinoren Rosacea is discontinued, skin symptoms may worsen. Consult your doctor before stopping treatment.
If you have any further questions about the use of Skinoren Rosacea, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Skinoren Rosacea may cause adverse effects, although not everyone will experience them.
Skin irritation (e.g., burning and itching) may occur. In most cases, symptoms of irritation are mild or moderate. The frequency of these symptoms decreases with longer duration of treatment.
The most commonly observed adverse effects are itching, burning, and pain at the application site.
During treatment with Skinoren Rosacea, the following adverse effects affecting the skin at the application site may occur:
Very common (may affect more than 1 in 10 people): burning, pain, itching at the application site;
Common (may affect up to 1 in 10 people): tingling or numbness (paresthesia), dry skin, rash, swelling (edema) at the application site;
Uncommon (may affect up to 1 in 100 people): acne, skin reaction to external agent (contact dermatitis), unnatural redness of the face (flushing), urticaria, sensation of discomfort at the application site;
Rare (may affect up to 1 in 1000 people):
- Hypersensitivity, which may present with one or more of the following adverse effects: angioedema (sudden swelling of the skin), eye swelling, facial swelling, shortness of breath;
- Skin irritation
- Urticaria
- Worsening of asthma symptoms
In clinical trials, skin discoloration at the site of application was observed in patients treated with azelaic acid in gel form for acne vulgaris, but not in patients treated for rosacea. However, this cannot be excluded (frequency not known).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Skinoren Rosacea
Keep out of the 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 specified month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.
6. Contents of the pack and other information
What Skinoren Rosacea contains
- The active substance is azelaic acid. 1 g of Skinoren Rosacea contains 150 mg of azelaic acid.
The other ingredients are: benzoic acid (E210), carbomer 980, disodium edetate, lecithin,
polysorbate 80, propylene glycol, purified water, sodium hydroxide and saturated medium-chain triglycerides.
What Skinoren Rosacea looks like and contents of the pack
Skinoren Rosacea is a white or yellowish-white, opaque gel.
The medicinal product is packed in an aluminium tube containing 30 g of gel, placed in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information, please contact the Marketing Authorisation Holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Austria, Netherlands, Estonia, Latvia, Lithuania, Slovakia – Finacea
Poland – Skinoren Rosacea.