AVATOP 1 mg/g CUTANEOUS EMULSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Avatop 1mg/g cutaneous emulsion

methylprednisolone aceponate

Contents of the pack:

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

1. What is Avatop and what is it 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 inflammation and allergic reactions of the skin, and reactions associated with excessive cell multiplication (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate on the 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 of habitual use, such as soap (irritant contact dermatitis).
  • Coin-shaped skin rash (nummular eczema).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).

• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).

Methylprednisolone aceponate may be used in adults, adolescents, children, and infants from 4 months or older (see sections "What you need to know before you use Avatop" and "How to use Avatop").

2. What you need to know before you use Avatop

Do not use Avatop:

• If you are allergic to the active ingredient methylprednisolone aceponate (MPA), benzyl alcohol, or 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.
• In areas of the skin affected by inflammation that is red/pink (rosacea), ulcers, inflammatory diseases of the sebaceous glands (acne vulgaris), or skin diseases with thinning of the skin (atrophic skin diseases).
• In areas of the skin showing a vaccination reaction, such as redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless they are adequately treated with a specific medicine).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Avatop.

Be particularly careful with this medicine if your doctor diagnoses a skin infection with bacteria or fungi; then, you should also use the additional treatment prescribed for the infection, because if not, the infection may worsen.

Anti-inflammatory medicines (corticosteroids), such as the active ingredient methylprednisolone aceponate of Avatop, have significant effects on the body. It is not recommended to use methylprednisolone aceponate on large areas of the skin or for prolonged periods, as this significantly increases the risk of side effects.

To reduce the risk of side effects:

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

If you use methylprednisolone aceponate for diseases other than those for which it has been prescribed, it may mask the symptoms and make it difficult to diagnose and treat correctly.

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 protection against sexually transmitted diseases, such as HIV infection. Consult your doctor or pharmacist if you need more information.

Children

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

Methylprednisolone aceponate should not be used under airtight and waterproof materials, such as diapers, unless prescribed by your doctor.

Methylprednisolone aceponate may be used in children between 4 months and 3 years if your doctor has prescribed it.

It is not recommended for use in children under 4 months of age due to lack of safety data.

Other medicines and Avatop

No interactions with other medicines are known at present.

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

Pregnancy and breastfeeding

To avoid any risk to the baby, do not use methylprednisolone aceponate if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, unless your doctor advises you to do so.

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

If you are pregnant or breastfeeding, think you may 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 use machines.

The active ingredient may cause visual disturbances. Patients who experience this side effect should avoid driving or using machines.

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

Unless your doctor tells you otherwise, the dosage is generally as follows:

• Apply methylprednisolone aceponate in a thin layer, once a day, to the affected skin area, rubbing gently.
• Generally, the duration of treatment with methylprednisolone aceponate should not exceed two weeks. Always make the treatment as short as possible.
• If you use methylprednisolone aceponate for a skin rash with inflammation (seborrheic eczema) and scaling on the face, do not treat for more than one week.
• If the skin becomes too dry, please consult your doctor. You may need to apply a regulating greasy ointment in addition.

Use in children

Methylprednisolone aceponate may be used in children between 4 months and 3 years if your doctor has prescribed it. No dose adjustment is required when this medicine is administered to infants from 4 months or older, children, and adolescents.

It is not recommendedto use methylprednisolone aceponate in children under 4 months of agedue to lack of safety data.

If you use more Avatop than you should

No risk is expected after a single overdose of methylprednisolone aceponate (too much, too large an area of skin, or too frequent use). Repeated overdoses may produce side effects (see section 4. Possible side effects).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone 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 forgotten doses; if you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in the package leaflet.

If you stop using Avatop

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

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

4. Possible side effects

Like all medicines, methylprednisolone aceponate can cause side effects, although not everybody gets them.

• Common (may affect up to 1 in 10 people):
• • Local skin irritation (such as burning sensation).

• Uncommon (may affect up to 1 in 100 people):
• • Pain,
  • Itching,
  • Small blisters and pustules,
  • Scaling,
  • Superficial wounds (erosion),
  • Worsening or recurrence of eczema,
  • Cracking of the skin.

The use of corticosteroids (such as the active ingredient of Avatop) on the skin may lead to the following side effects (frequency not known):

• Thinning of the skin (atrophy),
• Dry skin,
• Redness (erythema),
• Appearance of red spots,
• Follicular inflammation (folliculitis),
• Stretch marks,
• Acne,
• Specific skin inflammation around the upper lip and chin (perioral dermatitis),
• Allergic skin reaction (contact dermatitis),
• Changes in skin color,
• Increased body hair.
• Side effects may occur not only in the treated area but also in completely different areas of the body. This occurs if the active ingredient (a corticosteroid) passes into the body through the skin (is absorbed). This, for example, can increase pressure in the eye (glaucoma).
• Blurred vision.

Reporting of side effects:

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

5. Storage of Avatop

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 tube and carton, after EXP. The expiry date is the last day of the month shown.

Shelf life after first opening: 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

Composition of Avatop

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

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area 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 cutaneous emulsion

Date of last revision of this leaflet: April 2025

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