SKINATAN 1 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Skinatan 1 mg/ml Cutaneous Solution

Methylprednisolone aceponate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness 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.

Contents of the Package Leaflet

1. What is Skinatan and what is it used for
2. What you need to know before you use Skinatan
3. How to use Skinatan
4. Possible side effects
5. Storage of Skinatan
6. Contents of the pack and further information

1. What is Skinatan and what is it used for

This medicinal product contains the active substance methylprednisolone aceponate.

Methylprednisolone is an anti-inflammatory medicine (a corticosteroid) for use on the scalp in adults over 18 years of age.

This medicine is used to treat inflammatory and pruritic dermatoses (with itching) of the scalp, such as atopic dermatitis (neurodermatitis), seborrhoeic eczema, contact dermatitis, nummular eczema and unclassified eczema in adults over 18 years of age.

2. What you need to know before you use Skinatan

Do not useSkinatan:

• if you are allergic to methylprednisolone aceponate (MPA) or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from tuberculous or syphilitic processes or viral infections, such as herpes or chickenpox.
• on areas of skin affected by a red/pink inflammatory skin condition (rosacea), ulcers, inflammatory diseases of the sebaceous glands (acne vulgaris) or skin diseases accompanied by thinning of the skin (atrophic skin diseases).
• inflammation of the skin around the mouth (perioral dermatitis).
• on areas of skin with a reaction to a vaccine, i.e. red or inflamed after administration of a vaccine.
• on bacterial or fungal skin infections (unless they are being treated with a suitable medicine). See warnings and precautions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use methylprednisolone.

Be particularly careful with methylprednisolone if your doctor diagnoses a concomitant skin infection (bacterial or fungal). In this case, you should also use additional medicines prescribed for this infection; otherwise, the infection may worsen.

When using methylprednisolone, be careful to avoid applying it near open flames, as the solution is highly flammable.

Anti-inflammatory medicines (corticosteroids), such as the active substance methylprednisolone aceponate, have strong effects on the body. Therefore, it is not recommended to use methylprednisolone on large areas of the body or for prolonged periods, as this will considerably increase the risk of side effects.

To reduce the risk of side effects:

• use the smallest amount of methylprednisolone necessary;
• use methylprednisolone only for the time that is strictly necessary to relieve your skin disease;
• do not apply methylprednisolone to the eyes, open wounds or mucous membranes;
• do not use methylprednisolone under airtight and watertight dressings, such as bandages, plasters, clothing or nappies, unless your doctor has prescribed it.

Local skin infections may be worsened by the topical use of corticosteroids.

As with all other corticosteroids, the use of methylprednisolone for diseases other than those intended may mask their symptoms and make diagnosis and correct treatment more difficult.

Consult your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Do not administer methylprednisolone to children or adolescents under 18 years of age. There is no data available on safety and efficacy.

UsingSkinatanwith other medicines

So far, no interactions with other medicines have been reported for methylprednisolone.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

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 your baby, do not use this medicine if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, unless your doctor advises you to do so.

If your doctor recommends using methylprednisolone during breastfeeding, do not apply the medicine to the breasts. Do not let your baby come into contact with the treated areas.

There is no data available on the influence of methylprednisolone on fertility.

Driving and using machines

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

3. How to use Skinatan

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Unless your doctor has prescribed otherwise, methylprednisolone is used once a day.

• Apply methylprednisolone in the form of drops to the affected areas of the skin with a gentle massage.
• As a rule, methylprednisolone should not be used for more than 4 weeks in adults.

Consult your doctor or pharmacist if you feel that the effect of this medicine is too strong or too weak.

Use in children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age. There is no data available on safety and efficacy.

If you use moreSkinatanthan you should

No risk is expected from a single cutaneous application of an overdose (too large a skin surface).

Unintentional oral ingestion of a few milliliters of methylprednisolone may cause central nervous system depressant effects due to the excipient isopropyl alcohol.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to useSkinatan

Do not use a double dose of this medicine the next time; continue with the treatment as prescribed by your doctor or as described in this leaflet.

If you stop usingSkinatan

If you stop using methylprednisolone prematurely, the main symptoms of your skin disease may reappear. Therefore, consult your doctor before stopping or interrupting treatment.

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:

Very common: may affect more than 1 in 10 users

Common: may affect up to 1 in 10 users

Uncommon: may affect up to 1 in 100 users

Rare: may affect up to 1 in 1,000 users

Very rare: may affect up to 1 in 10,000 users

Frequency not known: cannot be estimated from the available data

Treatment with this medicine may cause the following side effects:

Common: burning sensation at the application site

Uncommon: seborrhoea of the scalp and hair loss at the application site: itching (pruritus), pain, inflammation of the hair follicles (folliculitis), heat, dry skin, irritation or eczema.

Frequency not known: acne, dilation of skin vessels (telangiectasia), thinning of the skin (skin atrophy), formation of stretch marks, inflammation of the skin around the mouth (perioral dermatitis), skin discoloration, allergic skin reactions and increased body hair growth (hypertrichosis).

In the application area:

small blisters, redness of the skin (erythema). Blurred vision.

After topical application of medicines containing corticosteroids, systemic effects may occur due to absorption into the body.

Reporting of side effects

If you experience 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 via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Skinatan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP:”. The expiry date refers to the last day of the month stated.

Do not store above 30°C.

After first opening, the product can be stored for 4 months if not stored above 25°C.

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 further information

Composition ofSkinatan

The active substance is methylprednisolone aceponate. 1 ml of solution contains 1 mg of methylprednisolone aceponate (equivalent to 0.1%, m/v).

The other ingredients are: isopropyl myristate and isopropyl alcohol.

Appearance of the product and pack contents

Skinatan 1 mg/ml Cutaneous Solution is a clear and colourless solution available in packs (HDPE bottle with LDPE dropper and HDPE screw cap in a cardboard box) with 20 ml, 30 ml and 50 ml of cutaneous solution.

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

Skin Care Pharma GmbH

Kastanienallee 46

15344 Strausberg

Germany

or

Aristo Pharma GmbH

Wallenroder Strasse 8-10

Berlin - 13435 – Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria Skinatan 1 mg/ml Lösung zur Anwendung auf der Haut

Czech Republic Methylprednisolon Aristo 1 mg/ml Kožní roztok

Germany MetiGalen 1 mg/ml Lösung zur Anwendung auf der Haut

Italy Skinatan 1 mg/ml Soluzione cutanea

Poland Skinatan 1 mg/ml Roztwór na skóre

Portugal Skinatan 1 mg/ml Solução cutânea

Spain Skinatan 1 mg/ml solución cutánea

Date of last revision of this leaflet: January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/