Package leaflet: Information for the user

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

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Skinatan, 1 mg/mL, cutaneous solution is and what it is used for
Important information before using Skinatan, 1 mg/mL, cutaneous solution
How to use Skinatan, 1 mg/mL, cutaneous solution
Possible side effects
How to store Skinatan, 1 mg/mL, cutaneous solution
Contents of the pack and other information

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

Skinatan contains the active substance methylprednisolone aceponate. Skinatan is a topical anti-inflammatory medicine (a corticosteroid) intended for use on the scalp skin in adults aged over 18 years.
Skinatan is used in the treatment of inflammatory and itchy dermatoses of the scalp skin, such as:
atopic dermatitis (neurodermatitis), seborrhoeic eczema, contact dermatitis, pompholyx, and unspecified eczema in adults aged over 18 years.

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

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

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 inflammation (rosacea), ulcers, inflammatory disorders of the sebaceous glands (acne vulgaris), or skin diseases associated with skin atrophy (atrophic skin disorders);
if the patient has perioral dermatitis;
on areas of skin showing a reaction to vaccination, i.e. redness or inflammation at the vaccination site;
on bacterial or fungal skin infections, unless appropriately treated with a specific medication (see "Warnings and precautions").

Warnings and precautions
Before starting treatment with Skinatan, consult your doctor or pharmacist.
Exercise particular caution when using Skinatan if the doctor has diagnosed the patient with a concurrent skin infection (bacterial or fungal). In such cases, the patient should also use additional medications prescribed for the infection, as otherwise the infection may worsen.
When using Skinatan, caution should be exercised and application near open flames should be avoided, as this solution is highly flammable.
Anti-inflammatory medicines (corticosteroids), such as the active substance methylprednisolone aceponate contained in Skinatan, have a potent effect on the body. 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 possible amount of Skinatan;
use Skinatan only for as long as absolutely necessary to relieve skin lesions;
do not apply Skinatan to the eyes, deep or open wounds, or mucous membranes;
do not use Skinatan under occlusive dressings such as bandages, impermeable wound coverings, clothing, or diapers, unless directed by a doctor.

Topically applied corticosteroids may exacerbate local skin infections.
As with all other corticosteroids, using Skinatan for conditions other than those for which it is indicated may mask their symptoms and complicate proper diagnosis and treatment.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought immediately.

Children and adolescents
Do not use Skinatan in children and adolescents under 18 years of age. There is insufficient data available on safety and efficacy in this age group.

Skinatan, 1 mg/mL, cutaneous solution and other medicines
No interactions between Skinatan and other medicines have been reported to date.
Inform your doctor or pharmacist about all medicines currently being taken or recently used, as well as any medicines the patient intends to take.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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, or if she suspects she may be pregnant or is 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. Contact between the treated skin areas and the infant must be avoided.

There are no available data on the effect of methylprednisolone aceponate on fertility in humans.

Driving and operating machinery
Skinatan, 1 mg/mL, cutaneous solution has no effect or negligible effect on the ability to drive or operate machinery.

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

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.

Unless otherwise prescribed by the physician, Skinatan should be applied once daily.
Apply Skinatan drops onto the affected skin area and gently rub in.
Skinatan should generally not be used in adults for longer than 4 weeks.

If you feel that the effect of Skinatan is too strong or too weak, consult your
doctor or pharmacist.
Use in children and adolescents
Skinatan must not be used in children and adolescents under 18 years of age. There are no available data
on safety and efficacy in this age group.
Use of a higher than recommended dose of Skinatan, 1 mg/mL, cutaneous solution
Overdose (single application over too large a skin surface area) is not expected to pose any
risk.
Accidental ingestion of several milliliters of Skinatan may cause central nervous system depression
due to the presence of isopropyl alcohol as an excipient.
Missed application of Skinatan, 1 mg/mL, cutaneous solution
Do not apply a double amount of Skinatan to the skin at the next dose. Continue treatment according
to your doctor's instructions or as described in this leaflet.
Discontinuation of Skinatan, 1 mg/mL, cutaneous solution
If Skinatan treatment is stopped prematurely, the initial skin symptoms may recur. Therefore,
consult your doctor before interrupting or stopping treatment.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The assessment of adverse reactions is based on the following frequency categories:
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data.

When using Skinatan 1 mg/mL solution for skin application, the following adverse reactions may occur:

Common: Burning at the application site.
Uncommon: Seborrhoea of the scalp and hair loss; at the application site: itching (pruritus), pain, folliculitis, increased temperature, dry skin, irritation or rash.
Frequency not known: Acne, cutaneous vasodilation (telangiectasia), skin atrophy (thinning), striae, perioral dermatitis, change in skin pigmentation, cutaneous allergic reactions, and hypertrichosis (excessive hair growth). At the application site: small blisters, erythema (redness). Blurred vision.

Systemic adverse effects may occur following topical application of corticosteroid-containing medicinal products due to their absorption into the body.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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

Keep the 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 stated month.
Medicines must 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 package and other information

What Skinatan, 1 mg/mL, cutaneous 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, cutaneous solution looks like and contents of the pack
Skinatan, 1 mg/mL, cutaneous solution is a clear, colourless solution available in packs (HDPE bottle with dropper made of LDPE and HDPE cap, in a cardboard box), containing 20 mL or 50 mL of cutaneous solution.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for marketing in the European Economic Area under the following names:
Austria Skinatan
Czech Republic Methylprednisolon Aristo
Germany MetiGalen
Italy Skinatan
Poland Skinatan
Portugal Skinatan
Spain Metilprednisolona Aristo