Skinatan

Package leaflet: Information for the user

Skinatan, 1 mg/g, emulsion for skin
Methylprednisolone aceponate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult 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 as yours.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Skinatan, 1 mg/g, emulsion for skin is and what it is used for
2. What you need to know before using Skinatan, 1 mg/g, emulsion for skin
3. How to use Skinatan, 1 mg/g, emulsion for skin
4. Possible side effects
5. How to store Skinatan, 1 mg/g, emulsion for skin
6. Contents of the pack and other information

1. What Skinatan, 1 mg/g, emulsion for skin is and what it is used for

Skinatan contains the active substance methylprednisolone aceponate. Skinatan is an anti-inflammatory medicine (a corticosteroid) intended for topical use on the skin.
Skinatan reduces skin inflammation and allergic reactions, as well as reactions associated with excessive skin cell division (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (oedema), and oozing from inflamed skin areas.
It also relieves itching, burning, or pain felt by the patient.
Skinatan is used to treat:

• mild to moderate acute skin rashes (eczema) caused by external factors, such as:
• allergy to a substance that has been in contact with the skin (allergic contact dermatitis),
• allergic reaction to everyday substances, e.g. soap (irritant contact dermatitis),
• coin-shaped skin rash (nummular eczema),
• itchy rash appearing on the palms and soles (dyshidrotic eczema),
• unspecified rash (common eczema);
• rashes caused by internal factors in the patient (endogenous eczema), such as: atopic dermatitis or neurodermatitis;
• scaling and skin rash with significant inflammation (seborrhoeic eczema).

Skinatan is indicated for use in adults, infants aged 4 months or older, children and adolescents.

2. Information before using Skinatan, 1 mg/g, emulsion for the skin

When not to use Skinatan, 1 mg/g, emulsion for the skin:

• if the patient is allergic to methylprednisolone aceponate (MPA) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has tuberculosis, syphilis, or viral infections such as herpes simplex or varicella (chickenpox);
• on areas of skin affected by red/rosy-colored inflammation (rosacea), ulceration, inflammatory sebaceous gland disease (acne vulgaris), or skin disorders associated with skin atrophy (atrophic skin diseases);
• on areas of skin showing a reaction to vaccination, i.e. redness or inflammation at the vaccination site;
• if the patient has perioral dermatitis (inflammation of the skin around the mouth);
• on bacterial or fungal skin infections (unless adequately treated with appropriate specific medication).

Warnings and precautions
Before starting treatment with Skinatan, discuss it with your doctor or pharmacist.
Exercise particular caution when using Skinatan if your doctor has diagnosed a concurrent bacterial or fungal skin infection. In such cases, the patient should also use additional prescribed medications to treat the infection, otherwise the infection may worsen.
Anti-inflammatory medicines (corticosteroids), such as the active substance methylprednisolone aceponate contained in Skinatan, have a potent systemic effect. Therefore, prolonged use or application over large areas of the body is not recommended, as this significantly increases the risk of adverse effects.
To reduce the risk of adverse effects:

• use the smallest amount of medicine possible;
• use the medicine only as long as absolutely necessary to relieve skin lesions;
• do not apply Skinatan to the eyes or mouth, deep open wounds, or mucous membranes (e.g. around the anus or genital organs);
• do not apply Skinatan over large areas of skin (greater than 40% of total body surface area);
• do not use Skinatan under occlusive, impermeable materials such as airtight or waterproof dressings, non-breathable bandages, clothing, or diapers, unless specifically instructed by a doctor.

If Skinatan is used for conditions other than those for which it is indicated, it may mask symptoms and complicate correct diagnosis and treatment.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If Skinatan is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. This may reduce their effectiveness in contraception or protection against sexually transmitted infections such as HIV.
For further information, consult your doctor or pharmacist.
Children
To minimize the risk of adverse effects, use the smallest possible amount of medicine. Skinatan should not be used under occlusive, impermeable materials such as diapers, unless specifically directed by a doctor.
Skinatan may be used in children aged 4 months to 3 years only if directed by a doctor.
Use of Skinatan is not recommended in children under 4 months of age.
Skinatan, 1 mg/g, emulsion for the skin and other medicines
No interactions between Skinatan and other medicines are currently known.
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
To avoid any risk to the child, the patient should not use Skinatan during pregnancy or breastfeeding, if she suspects she might be pregnant, or when planning to become pregnant, unless otherwise advised by a doctor.
If a doctor prescribes Skinatan during breastfeeding, the medicine should not be applied to the breasts. Avoid contact between the treated skin areas and the infant.
Driving and operating machinery
Skinatan has no effect or a negligible effect on the ability to drive and operate machinery.
Skinatan, 1 mg/g, emulsion for the skin contains benzyl alcohol (E 1519)
This medicine contains 12.5 mg of benzyl alcohol per 1 g of emulsion.
Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Skinatan, 1 mg/g, emulsion for the skin

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
If the doctor has not prescribed otherwise, use the medicine according to the following instructions:

• apply Skinatan once daily, in a thin layer, to the affected skin area and gently rub in;
• Skinatan should usually not be used for longer than 2 weeks. Treatment should always be limited to the shortest possible duration;
• when using Skinatan on peeling skin and on skin with rash and inflammatory condition (seborrheic dermatitis) on the face, the medicine should not be used for longer than one week;
• if the skin is excessively dry, consult your doctor or pharmacist. Additional use of a lipid-regulating ointment may be necessary.

Use in children
Skinatan may be used in children aged from 4 months to 3 years, if prescribed by a doctor. There is
no need to adjust the dosage.
Use of Skinatan is not recommended in children under 4 months of age due to lack of safety data.
Use of more than the recommended dose of Skinatan, 1 mg/g, emulsion for the skin
A single overdose (application of too large an amount of the medicine, application over too large
a skin surface, or excessively frequent use) is not expected to pose any risk. Repeated overdoses
may lead to adverse effects (see section 4. Side effects).
Missed application of Skinatan, 1 mg/g, emulsion for the skin
Do not apply a double amount of Skinatan next time to make up for a missed dose. Continue treatment
according to the doctor's or pharmacist's advice or as stated in this leaflet.
Stopping treatment with Skinatan, 1 mg/g, emulsion for the skin
If treatment with Skinatan is stopped prematurely, the initial skin symptoms may recur. Consult your
doctor or pharmacist before discontinuing treatment with Skinatan. If you have any further doubts
regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The assessment of side effects is based on the following frequency categories:
Common: may occur in up to 1 in 10 patients

• local skin irritation (for example, burning sensation)

Uncommon: may occur in up to 1 in 100 patients

• pain
• itching
• small blisters or pimples
• skin peeling
• superficial wounds (abrasions)
• worsening or recurrence of rash
• skin cracks

Unknown: frequency cannot be determined from available data.
The use of anti-inflammatory medicines, so-called corticosteroids (such as the active substance in Skinatan), on the skin may cause the following unexpected side effects (frequency unknown):

• thinning (atrophy) of the skin
• dry skin
• redness of the skin (erythema)
• appearance of red spots
• folliculitis
• skin striae (stretch marks)
• acne
• a specific inflammatory skin condition around the mouth (perioral dermatitis)
• skin allergic reactions (contact dermatitis)
• skin discoloration
• excessive hair growth on the body
• side effects may occur not only at the site of application but also in completely different areas of the body. This may happen if the active substance (corticosteroid) is absorbed through the skin into the body. This may, for example, lead to increased eye pressure (glaucoma).
• blurred vision

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can also 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 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Skinatan, 1 mg/g, cutaneous emulsion

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not store in a refrigerator or freeze.
Do not use this medicine after the expiry date stated on the tube and carton after "EXP".
The expiry date refers to the last day of the stated month.
The shelf-life after first opening the tube is 6 months.
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 packaging and other information

What Skinatan, 1 mg/g, emulsion for the skin contains

• The active substance is methylprednisolone aceponate.
• The other ingredients are: medium-chain triglycerides, hard fat, cetyl alcohol polyether-2, cetyl alcohol polyether-21, benzyl alcohol, disodium edetate, glycerol 85%, purified water.

What Skinatan, 1 mg/g, emulsion for the skin looks like and contents of the pack
Skinatan is a white or almost white, homogeneous emulsion for skin application (cream-like) available in tubes containing:

• 20 g
• 50 g
• 100 g

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Skin Care Pharma GmbH
Kastanienallee 46
15344 Strausberg
Germany
Manufacturer
Paul W. Beyvers GmbH
Schaffhausener Strasse 26-34
12099 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Skinatan, 1 mg/g Emulsion zur Anwendung auf der Haut
Czech Republic Methylprednisolon Aristo, 1 mg/g Kožní emulze
Italy Metilprednisolone Aristo, 1 mg/g Emulsione cutanea
Poland Skinatan, 1 mg/g, emulsja na skórę
Portugal Metilprednisolona Aristo, 1 mg/g Emulsão cutânea
Spain Metilprednisolona Aristo, 1 mg/g Emulsión cutánea