Avatop 1 mg/g cutaneous emulsion

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Avatop 1mg/g cutaneous emulsion

methylprednisolone aceponate

Contents of the leaflet:

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

1. What Avatop is and what it is used for

Avatop contains the active substance, methylprednisolone aceponate.

Avatop is an anti-inflammatory medicine (a corticosteroid) for use on the skin.

Methylprednisolone aceponate reduces skin inflammation and allergic reactions, as well as reactions associated with excessive multiplication of skin cells (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate in inflamed skin. It also relieves itching, burning, or pain.

Methylprednisolone aceponate is used to treat acute forms of:

• Mild to moderate skin rash (eczema) related to an external cause, such as:

  • Allergy to a substance that has come into contact with your skin (allergic contact dermatitis).
  • Allergic reaction to substances commonly used, for example, soap (irritant contact dermatitis).
  • Coin-shaped skin rash (nummular eczema).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (vulgar eczema).

• Eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.

• Skin rash with inflammation and scaling (seborrheic eczema).

Methylprednisolone aceponate can be used in adults, adolescents, children, and infants from 4 months of age (see the sections “What you need to know before using Avatop” and “How to use Avatop”).

2. What you need to know before using Avatop

Do not use Avatop:

• If you are allergic to the active substance methylprednisolone aceponate (MPA), benzyl alcohol, or to any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections such as chickenpox or herpes.
• On areas of skin affected by red/pink inflammation (rosacea), ulcers, inflammatory skin conditions of the sebaceous glands (common acne), or skin diseases with thinning of the skin (atrophic skin disorders).
• On areas of skin showing a vaccine reaction, for example, redness or swelling after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless adequately treated with a specific medication).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Avatop.

Take special care with this medicine if your doctor also diagnoses a bacterial or fungal skin infection; in such cases, you must also use the additional prescribed treatment for the infection, otherwise the infection may worsen.

Anti-inflammatory drugs (corticosteroids), such as the active substance methylprednisolone aceponate in Avatop, have significant effects on the body. The use of methylprednisolone aceponate over large areas of skin or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

• Use it as little as possible.
• Use it only for the shortest time necessary to relieve the skin condition.
• Methylprednisolone aceponate must not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (e.g., anal or genital areas).
• Methylprednisolone aceponate should not be used over large areas of skin (more than 40% of body surface area).
• Methylprednisolone aceponate should not be used under materials impermeable to air and water, including bandages, non-breathable dressings, clothing, or diapers, unless specifically prescribed by your doctor.

If methylprednisolone aceponate is used for conditions other than those for which it was prescribed, it may mask symptoms and interfere with correct diagnosis and treatment.

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

If methylprednisolone aceponate is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. Therefore, they may no longer be effective as contraceptives or for protection against sexually transmitted infections, such as HIV infection. Consult your doctor or pharmacist if you need further information.

Children

Use methylprednisolone aceponate as little as possible to reduce the risk of adverse effects.

Methylprednisolone aceponate should not be used under materials impermeable to air and water, such as diapers, unless specifically prescribed by your doctor.

Methylprednisolone aceponate may be used in children between 4 months and 3 years of age if prescribed by your doctor.

It is not recommended for use in children under 4 months of age.

Other medicines and Avatop

No interactions between methylprednisolone aceponate and other medicines are currently known.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

To avoid any risk to the child, you must not use methylprednisolone aceponate if you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, unless instructed by your doctor.

If your doctor recommends using methylprednisolone aceponate during breastfeeding, do not apply the medicine to the breasts and avoid contact between the treated areas and the child.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Methylprednisolone aceponate does not affect your ability to drive or operate machinery.

However, the active substance may cause visual disturbances. Patients experiencing this adverse effect should refrain from driving or operating machinery.

Avatop contains benzyl alcohol

This medicine contains 12.5 mg of benzyl alcohol per gram.

Benzyl alcohol may cause allergic reactions and/or moderate local irritation.

3. How to use Avatop

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

Unless otherwise directed by your doctor, the usual dosage is as follows:

• Apply metilprednisolone aceponate as a thin layer once daily to the affected area of skin, rubbing in gently.
• In general, treatment with metilprednisolone aceponate should not last longer than two weeks. Always keep the treatment duration as short as possible.
• If you are using metilprednisolone aceponate for inflammatory skin rash (seborrheic eczema) with scaling on the face, do not treat for longer than one week.
• If your skin becomes excessively dry, please consult your doctor. A moisturizing emollient ointment may need to be applied additionally.

Use in children

Metilprednisolone aceponate may be used in children between 4 months and 3 years of age if prescribed by your doctor. No dose adjustment is required when this medicine is administered to infants from 4 months of age, children, and adolescents.

Metilprednisolone aceponate is not recommended in children under 4 months of age due to lack of safety data.

If you use more Avatop than you should

No risk is expected after a single overdose of metilprednisolone aceponate (too large amount, too large skin area, or too frequent use). Repeated overdoses may lead to adverse effects (see section 4. Possible side effects).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Avatop

Do not use a double dose to make up for missed doses. If you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in this leaflet.

If you stop using Avatop

If you stop using metilprednisolone aceponate prematurely, the original symptoms of your skin condition may return. Please contact your doctor or pharmacist before stopping treatment with metilprednisolone aceponate.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, methylprednisolone aceponate may produce adverse effects, although not everyone experiences them.

• 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 and pustules,
  • peeling,
  • superficial skin lesions (erosion),
  • worsening or recurrence of eczema,
  • skin cracking.

The use of topical corticosteroids (such as the active substance in Avatop) may lead to the following adverse effects (frequency is not known ):

• thinning of the skin (atrophy),
• dry skin,
• redness (erythema),
• appearance of red spots,
• inflammation of hair follicles (folliculitis),
• stretch marks,
• acne,
• specific skin inflammation around the upper lip and chin (perioral dermatitis),
• allergic skin reaction (contact dermatitis),
• changes in skin colour,
• increased body hair growth.
• adverse effects may occur not only in the treated area, but also in completely different areas of the body. This may happen if the active substance (a corticosteroid) passes through the skin into the body (is absorbed). For example, this could increase eye pressure (glaucoma).
• blurred vision.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Avatop

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the tube and carton, following EXP. The expiry date refers to the last day of the month indicated.

Period of validity after first opening: 6 months

Medicines must not be disposed of via wastewater or in household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Avatop

• The active substance is methylprednisolone aceponate (MPA).
• The other components (excipients) are: medium-chain triglycerides, semi-synthetic solid glycerides, macrogol-2-stearyl ether, macrogol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol (85%), and purified water.

Appearance of the product and contents of the container

Avatop is a white cutaneous emulsion (similar to a milky cream) available in tubes of 20 g, 50 g, and 100 g.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Mibe Pharma España S.L.U.

C/ Amaltea 9, 4th floor, letter B

28045, Madrid

Spain

Manufacturer:

Mibe GmbH Arzneimittel

Münchener Strasse, 15

06796 Brehna

Germany

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Austria: Avatop Milch 1mg/g Emulsion zur Anwendung auf der Haut
Germany: Avatop Milch 1 mg/g Emulsion zur Anwendung auf der Haut
Italy: Emulprea
Spain: Avatop 1 mg/g emulsión cutánea

Date of the most recent review of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es