Adventan 1 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adventan 1mg/g cream

Methylprednisolone aceponate

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Adventan cream and what is it used for?

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

Adventan cream reduces inflammation and allergic reactions of the skin, 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.

Adventan cream is used in the treatment of:

• Mild to moderate acute eczema related to an external cause, such as:
  • Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to substances commonly used, such as soap (irritant contact dermatitis).
  • Coin-shaped rash (nummular eczema).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (common eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).

This cream formulation is particularly indicated for exudative conditions (those that secrete fluid).

2. What you need to know before using Adventan cream

Do not use Adventan cream

• If you are allergic to methylprednisolone aceponate (MPA) or to any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes).
• If you have rosacea (a condition causing red/pink skin inflammation), ulcers, acne, or skin diseases associated with thinning of the skin (atrophy).
• On areas of 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 case of bacterial or fungal infections; see section “Warnings and precautions”.
• Must not be used in the eyes or on deep open wounds.
• Children under four months of age, due to lack of experience.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Adventan cream.

If your doctor also diagnoses a bacterial or fungal infection, you must use the additional prescribed treatment for the infection, because otherwise the infection may worsen.

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

Anti-inflammatory drugs (corticosteroids), such as the active ingredient MPA in Adventan, have significant effects on the body. The use of Adventan 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 the lowest possible dose, especially in children.
• Use only for the minimum time necessary to relieve the skin condition.
• Adventan cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., anal or genital areas).
• Must not be used in skin folds, groin, or armpits.
• Must not be used under occlusive, air- and water-impermeable materials, including dressings (unless directed by your doctor), bandages, clothing, or non-breathable diapers.

If Adventan is used for conditions other than those for which it was prescribed, it may mask symptoms and make correct diagnosis and treatment more difficult.

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

Children

It is important to note that diapers may be occlusive. If your doctor has previously assessed the benefits and risks, Adventan cream may be prescribed for use in children between 4 months and 3 years of age.

Use of Adventan cream with other medicines

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

No interactions between Adventan cream and other medicines are currently known.

Pregnancy, breastfeeding, and fertility

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

To avoid any risk to the child, you must not use Adventan cream during pregnancy or breastfeeding unless instructed by your doctor.

If your doctor recommends using Adventan cream while breastfeeding, do not apply the medicine to the breasts and avoid contact between the treated areas and the child.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Adventan cream contains cetostearyl alcohol, butylhydroxytoluene (E-321), and benzyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol and butylhydroxytoluene.

This medicine may cause eye and mucous membrane irritation due to the presence of butylhydroxytoluene.

This medicine contains 1.0 g of benzyl alcohol in each 100 g of cream.

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

3. How to use Adventan cream

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

Unless your doctor tells you otherwise, the recommended dose is:

For cutaneous use.

• Apply a thin layer of Adventan cream once daily to the affected area, rubbing in gently.
• In general, treatment duration should not exceed 12 weeks. Always keep the treatment as short as possible.
• Intermittent treatment is recommended when prolonged treatment is required.
• If you are using Adventan for a skin rash with inflammation and scaling (seborrheic eczema) on the face, do not treat the affected areas for longer than one week.

If your skin becomes excessively dry during treatment, consult your doctor. Depending on the type of affected skin, it is recommended to switch treatment to another product from the Adventan range with a higher fat content (Adventan ointment or Adventan salve).

Use in children

Adventan cream must not be used in children under four months of age due to lack of safety data.

Treatment duration in children should be kept to a minimum and generally should not exceed 4 weeks.

If you use more Adventan cream than you should

Acute intoxication is not expected after a single cutaneous overdose (application over a large area, under conditions favorable for absorption) or after accidental ingestion.

In case of overdose or accidental ingestion, consult 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 Adventan cream

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

If you stop using Adventan cream

If you stop treatment prematurely, the original symptoms of your skin condition may reappear. Contact your doctor before stopping treatment with Adventan cream.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The assessment of adverse 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
Frequency not known (cannot be estimated from available data)

• Common:
  Burning and itching at the application site.

• Uncommon:
  Hypersensitivity to the active substance.
  Blisters (vesicles), dryness, redness (erythema), inflammation of the hair follicle (folliculitis), rashes, and abnormal skin sensations such as numbness, tingling, or burning (paraesthesia).

• Rare:
  Fungal infection.
  Skin cracking, acne, pus-forming infection (pyoderma), dilated blood vessels in the skin (telangiectasias), and thinning of the skin (atrophy).
  Cellulitis, swelling (edema), and irritation at the application site.

• Frequency not known:
  Stretch marks (striae), specific skin inflammation around the upper lip and chin (perioral dermatitis), skin discoloration, and skin allergic reactions.
  Increased hair growth (hypertrichosis). Blurred vision.

Adverse effects may occur not only in the treated area but also in completely different parts of the body. This may happen if the active substance (a corticosteroid) passes into the body through the skin. For example, this could increase eye pressure (glaucoma).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adventan cream

Do not store above 25°C. Do not refrigerate or freeze.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adventan cream

• The active substance is methylprednisolone aceponate (MPA). Each gram of cream contains 1 mg of methylprednisolone aceponate (0.1%).
• The other components (excipients) are: decyl oleate, glycerol monostearate 40-50%, cetearyl alcohol, hard fat, caprylic-capric-mystiric-stearic triglycerides, polyoxyl 40 stearate, glycerol 85% (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321), and purified water.

Appearance of the product and contents of the pack

Adventan cream is an opaque white cream and is available in 30 g and 60 g tubes.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Date of the most recent revision of this leaflet: December 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/