Skinatan

Package Leaflet: Information for the User

Skinatan, 1 mg/g, Skin Emulsion

Methylprednisolone Aceponate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Skinatan, 1 mg/g, Skin Emulsion and what is it used for
• 2. Important information before using Skinatan, 1 mg/g, Skin Emulsion
• 3. How to use Skinatan, 1 mg/g, Skin Emulsion
• 4. Possible side effects
• 5. How to store Skinatan, 1 mg/g, Skin Emulsion
• 6. Contents of the pack and other information

1. What is Skinatan, 1 mg/g, Skin Emulsion and what is it used for

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

• mild to moderate acute skin rash (dermatitis) caused by external factors, such as:
• allergic contact dermatitis,
• irritant contact dermatitis (e.g., from soap),
• nummular dermatitis,
• dyshidrotic dermatitis (pompholyx),
• unspecified dermatitis (atopic dermatitis);
• dermatitis caused by factors occurring in the patient (endogenous eczema), such as atopic dermatitis or neurodermatitis;
• psoriatic dermatitis with significant inflammation.

Skinatan is indicated for use in adults, infants from 4 months of age, children, and adolescents.

2. Important information before using Skinatan, 1 mg/g, Skin Emulsion

When not to use Skinatan, 1 mg/g, Skin Emulsion:

• 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 or chickenpox;
• on skin areas with red/pink inflammation (rosacea), ulcers, inflammatory diseases of the sebaceous glands (acne), or skin diseases with accompanying skin thinning (atrophic skin diseases);
• on skin areas with visible vaccination reactions, i.e., red or inflamed areas after vaccination;
• if the patient has perioral dermatitis;
• on bacterial or fungal skin infections (unless they are properly treated with a special medicine).

Warnings and precautions

Before starting to use Skinatan, discuss it with your doctor or pharmacist.
Particular caution is required when using Skinatan if the doctor has diagnosed a concurrent skin infection (bacterial or fungal). In such cases, the patient should also use additional medicines prescribed for this infection, as otherwise, the infection may worsen.
Anti-inflammatory medicines (corticosteroids), such as the active substance methylprednisolone aceponate contained in Skinatan, have a strong effect on the body. Therefore, it is not recommended to use Skinatan on large areas of the body or for a long time, as this significantly increases the risk of side effects.
To minimize the risk of side effects:

• use the smallest possible amount of medicine;
• use the medicine only for as long as it is absolutely necessary to alleviate skin changes;
• do not use Skinatan on the eyes or mouth, on deep open wounds, or on mucous membranes (e.g., around the anus or genital areas);
• do not use Skinatan on large skin areas (larger than 40% of the total body surface area);
• do not use Skinatan under airtight or watertight dressings or bandages, unless your doctor has told you to.

If the patient uses Skinatan for diseases other than those for which it is indicated, it may mask their symptoms and make proper diagnosis and treatment difficult.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If Skinatan is applied to the genital or anal area, some of its ingredients may damage latex products, such as condoms or diaphragms. This may reduce their effectiveness as a contraceptive or in protecting against sexually transmitted diseases such as HIV.
For further information, talk to your doctor or pharmacist.

Children

To minimize the risk of side effects, use the smallest possible amount of medicine. Skinatan should not be used under airtight or watertight dressings or bandages, such as diapers, unless your doctor has told you to.
Skinatan may be used in children from 4 months to 3 years of age, only if prescribed by a doctor.
Skinatan should not be used in children under 4 months of age.

Skinatan, 1 mg/g, Skin Emulsion and other medicines

No interactions with other medicines are known for Skinatan.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
To avoid any risk to the baby, you should not use Skinatan if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, unless your doctor considers it necessary.
If your doctor advises you to use Skinatan during breastfeeding, do not apply the medicine to the breasts. Avoid contact between the baby and the treated skin areas.

Driving and using machines

Skinatan has no or negligible influence on the ability to drive and use machines.

Skinatan, 1 mg/g, Skin Emulsion contains benzyl alcohol (E 1519)

This medicine contains 12.5 mg of benzyl alcohol in 1 g of emulsion.
Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Skinatan, 1 mg/g, Skin Emulsion

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Unless your doctor has prescribed otherwise, use the medicine as follows:

• apply Skinatan once a day, in a thin layer, to the affected skin area and gently rub in;
• do not use Skinatan for more than 2 weeks. Treatment should always be limited to the shortest duration necessary;
• when using Skinatan on the face for psoriatic dermatitis, do not use it for more than one week;

Use in children

Skinatan may be used in children from 4 months to 3 years of age, if prescribed by a doctor. No dose adjustment is necessary.
Skinatan should not be used in children under 4 months of age due to lack of safety data.

Using more than the recommended dose of Skinatan, 1 mg/g, Skin Emulsion

It is not expected that a single overdose (using too much medicine, applying it to too large a skin area, or applying it too frequently) will be associated with any risk. Repeated overdoses may cause side effects (see section 4).

Missing a dose of Skinatan, 1 mg/g, Skin Emulsion

Do not use a double dose of Skinatan to make up for a forgotten dose. Instead, continue with the next dose as planned.

Stopping use of Skinatan, 1 mg/g, Skin Emulsion

If you stop using Skinatan too early, your skin problem may come back. Before stopping the treatment, talk to your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The evaluation of side effects is based on the following frequencies:

Common: may affect up to 1 in 10 people

• local skin irritation (e.g., burning sensation)

Uncommon: may affect up to 1 in 100 people

• pain
• itching
• small blisters or pustules
• skin peeling
• superficial wounds (erosions)
• worsening or recurrence of dermatitis
• skin cracks.

Unknown: frequency cannot be estimated from the available data.
Using anti-inflammatory medicines (corticosteroids) like the active substance in Skinatan on the skin may cause the following unexpected side effects (frequency unknown):

• skin thinning (atrophy)
• dry skin
• redness of the skin (erythema)
• appearance of red spots
• folliculitis
• skin stretch marks
• acne
• specific skin inflammation 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 other areas of the body. This happens if the active substance (corticosteroid) is absorbed through the skin into the body. It may cause, for example, increased eye pressure (glaucoma).
• blurred vision.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skinatan, 1 mg/g, Skin Emulsion

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date which is stated on the tube and carton after “EXP”.
The expiry date refers to the last day of that month.
The shelf-life after first opening the tube is 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Skinatan, 1 mg/g, Skin Emulsion contains

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

What Skinatan, 1 mg/g, Skin Emulsion looks like and contents of the pack

Skinatan is a white or almost white, homogeneous emulsion for use on the skin (similar to cream) and is 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 medicine 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

Date of last revision of the package leaflet: