ADVENTAN 1 mg/g CUTANEOUS EMULSION

2. What you need to know before you use Adventan emulsion

Do not use Adventan emulsion:

• If you are allergic to the active ingredient methylprednisolone aceponate (MPA) 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 red/pink inflammation (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophic skin diseases).
• In areas of the skin showing a vaccination reaction, for example, 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 Adventan emulsion.

Be particularly careful 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 drugs (corticosteroids), such as the active ingredient MPA of Adventan emulsion, have significant effects on the body. The use of Adventan emulsion is not recommended in 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 at the lowest possible dose.
• Use it only for the time absolutely necessary to relieve the skin condition.
• Adventan emulsion should not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (e.g., anal or genital area).
• Adventan emulsion should not be used on large areas of skin (more than 40% of the body surface).
• Adventan emulsion should not be used under airtight and waterproof materials, including bandages, dressings, non-breathable clothing, or diapers, unless prescribed by your doctor.

If you use Adventan emulsion for diseases other than those for which it has been prescribed, it may mask symptoms and hinder correct diagnosis and treatment.

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

If Adventan emulsion 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 Adventan emulsion as little as possible to reduce the risk of side effects.

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

Adventan emulsion can 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.

Using Adventan emulsion with other medicines

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, including those obtained without a prescription.

Pregnancy and breastfeeding

To avoid any risk to the baby, do not use Adventan emulsion 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 Adventan emulsion during breastfeeding, do not apply the medicine to the breasts; do not let the child 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

Adventan emulsion does not affect your ability to drive or use machines.

Adventan emulsion contains benzyl alcohol

This medicine contains 1.25 g of benzyl alcohol per 100 g. Benzyl alcohol may cause allergic reactions and/or moderate local irritation.

3. How to use Adventan emulsion

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

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

• Apply Adventan emulsion, in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the treatment duration with Adventan emulsion should not exceed two weeks. Always make the treatment as short as possible.
• If you use Adventan emulsion for a skin rash with inflammation (seborrheic eczema) and scaling of 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 as well.

Use in children

Adventan emulsion can be used in children between 4 months and 3 years if your doctor has prescribed it. No dose adjustments are required.

The use of Adventan emulsion is not recommended in children under 4 months of age due to lack of safety data.

If you use more Adventan emulsion than you should

No risk is expected after a single overdose of Adventan emulsion (too much, too large a skin area, 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 Adventan emulsion

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 leaflet.

If you stop using Adventan emulsion

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

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

4. Possible side effects

Like all medicines, Adventan emulsion can cause side effects, although not everybody gets them.

The assessment of side effects is based on the following frequencies:

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

Frequency not known: cannot be estimated from the available data

• Common:
• • Local skin irritation (e.g., burning sensation).

• Uncommon:
• • Pain,
  • Itching,
  • Small blisters and pustules,
  • Scaling,
  • Superficial wounds (erosion),
  • Worsening or return of eczema,
  • Cracking of the skin.

The use of anti-inflammatory drugs, called corticosteroids (such as the active ingredient of Adventan emulsion), 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,
• Inflammation of the hair follicle (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, may 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 Medicines and Health Products Agency: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adventan emulsion

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month shown.

Shelf-life after first opening: 3 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 further information

Composition of Adventan emulsion

• The active ingredient is methylprednisolone aceponate (MPA).
• The other ingredients (excipients) are: medium-chain triglycerides, capric/caprylic/myristic/stearic triglyceride, macrogol-2-stearate, macrogol-21-stearate, benzyl alcohol, disodium edetate, glycerol (85%), and purified water.

Appearance of the product and pack contents

Adventan emulsion is a white cutaneous emulsion (similar to an opaque milky cream) and is available in tubes of:

• 20 g
• 50 g
• 100 g

The tube has a removable seal.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

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

Austria, Finland, Germany, Italy, Portugal: Advantan

Spain: Adventan

Date of last revision of this leaflet: July 2019

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.