Skinatan

Package Leaflet: Information for the User

Skinatan, 1 mg/mL, Skin Solution

Methylprednisolone aceponate

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

• Keep this 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Skinatan, 1 mg/mL, skin solution and what is it used for

Skinatan contains the active substance methylprednisolone aceponate. Skinatan is an anti-inflammatory medicine (corticosteroid) for use on the scalp in adults over 18 years of age.
Skinatan is used to treat inflammatory and itchy skin conditions on the scalp, such as:
atopic dermatitis (neurodermatitis), seborrhoeic dermatitis, contact dermatitis, nummular dermatitis, and unspecified dermatitis in adults over 18 years of age.

2. Important information before using Skinatan, 1 mg/mL, skin solution

When not to use Skinatan, 1 mg/mL, skin solution:

• if you are allergic to methylprednisolone aceponate (MPA) or any of the other ingredients of this medicine (listed in section 6);
• if you have tuberculosis, syphilis, or viral infections such as herpes or chickenpox;
• on skin surfaces with red/pink inflammation (rosacea), ulcers, inflammatory diseases of the sebaceous glands (acne), or skin diseases with accompanying skin thinning (atrophic skin diseases);
• if you have inflammation of the skin around the mouth;
• on skin surfaces with visible vaccination reactions, i.e., in areas reddened or inflamed after vaccination;
• on bacterial or fungal skin infections, unless they are properly treated with a special medicine (see "Warnings and precautions").

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 you. In such a situation, you should also use additional medicines prescribed for this infection, as otherwise, the infection may worsen.
When using Skinatan, be cautious and avoid applying it near an open flame, as this solution is highly flammable.
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 a large area of the body or for a long time, as this significantly increases the risk of side effects.
To reduce the risk of side effects:

• use the smallest possible amount of Skinatan;
• use Skinatan only for as long as it is absolutely necessary to alleviate skin changes;
• do not use Skinatan on the eyes, on deep, open wounds, or on mucous membranes;
• do not use Skinatan under airtight materials, such as bandages, dressings that do not allow air to pass through, clothing, or diapers, unless your doctor has advised you to do so.

Locally used corticosteroids can exacerbate local skin infections.
As with all other corticosteroids, using Skinatan in diseases other than those for which it is indicated may mask their symptoms and make it difficult to diagnose and treat them properly.
If you experience blurred vision or other vision disturbances, contact your doctor.

Children and adolescents

Do not use Skinatan in children and adolescents under 18 years of age. There are no available data on the safety and efficacy of use.

Skinatan, 1 mg/mL, skin solution and other medicines

No interactions with other medicines have been identified so far.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
To avoid any risk to the child, you should not use Skinatan if you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, unless your doctor advises you to do so.
If your doctor advises you to use Skinatan while breastfeeding, do not apply the medicine to your breasts. Do not let your child come into contact with the treated skin areas.
There are no available data on the effect of methylprednisolone on fertility in humans.

Driving and using machines

Skinatan, 1 mg/mL, skin solution has no or negligible influence on the ability to drive and use machines.

3. How to use Skinatan, 1 mg/mL, skin solution

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

• If your doctor has not prescribed otherwise, use Skinatan once a day.
• Apply Skinatan drop by drop to the affected skin and gently rub in.
• Skinatan should not be used in adults for more than 4 weeks.

If you feel that the effect of Skinatan is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents

Do not use Skinatan in children and adolescents under 18 years of age. There are no available data on the safety and efficacy of use.

Using a higher dose of Skinatan, 1 mg/mL, skin solution than recommended

Overdose (single use on too large a skin area) is not expected to be associated with any risk.
Accidental ingestion of a few milliliters of Skinatan may have a sedative effect on the central nervous system due to the content of isopropyl alcohol as an excipient.

Missing a dose of Skinatan, 1 mg/mL, skin solution

Do not use a double dose of Skinatan on the skin at the next use, but continue treatment according to your doctor's instructions or this leaflet.

Stopping use of Skinatan, 1 mg/mL, skin solution

If you stop using Skinatan too early, the initial symptoms of your skin condition may return. Therefore, before stopping or finishing treatment, consult your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Skinatan can cause side effects, although not everybody gets them.
The evaluation of side effects is based on the following frequencies:
Very common:
may affect more than 1 in 10 people
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Very rare:
may affect up to 1 in 10,000 people
Not known:
frequency cannot be estimated from the available data.
During treatment with Skinatan, 1 mg/mL, skin solution, the following side effects may occur:
Common:
burning sensation at the application site.
Uncommon:
seborrhoeic dermatitis of the scalp and hair loss; at the application site: itching (pruritus), pain, folliculitis, increased heat, dryness of the skin, irritation, or eczema.
Frequency not known:
acne, telangiectasia, skin thinning (atrophy), stretch marks, perioral dermatitis, skin discoloration, allergic skin reactions, and excessive hair growth on the body. At the application site: small blisters, skin redness (erythema). Blurred vision.
After local use of corticosteroid medicines, systemic side effects may occur due to their absorption into the body.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skinatan, 1 mg/mL, skin solution

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Shelf life after first opening the bottle: 4 months.
Storage conditions after first opening the bottle: do not store above 25°C.
Do not use this medicine after the expiry date stated on the container and carton after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Skinatan, 1 mg/mL, skin solution contains

The active substance is methylprednisolone aceponate.
1 mL of solution contains 1 mg of methylprednisolone aceponate.
The other ingredients are isopropyl alcohol and isopropyl myristate.

What Skinatan, 1 mg/mL, skin solution looks like and contents of the pack

Skinatan, 1 mg/mL, skin solution is a clear, colorless solution available in packs (HDPE bottle with LDPE dropper and HDPE cap in a cardboard box) containing 20 mL and 50 mL of skin solution.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder and manufacturer

Marketing authorization holder

Skin Care Pharma GmbH
Kastanienallee 46
15344 Strausberg
Germany

Manufacturer

Skin Care Pharma GmbH

Kastanienallee 46
15344 Strausberg
Germany
or

Aristo Pharma GmbH

Wallenroder Str. 8 - 10
13435 Berlin
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Skinatan
Czech Republic
Methylprednisolone Aristo
Germany
MetiGalen
Italy
Skinatan
Poland
Skinatan
Portugal
Skinatan
Spain
Metilprednisolona Aristo

Date of last revision of the leaflet: