PATIENT INFORMATION LEAFLET

Adventan 1mg/g topical emulsion

Methylprednisolone aceponate

1.What is Adventan emulsion and what it is used for

2.What you need to know before using Adventan emulsion

3.How to use Adventan emulsion

4.Possible side effects

5.Storage of Adventan emulsion

6.Contents of the pack and additional information

Adventan emulsion contains the active substance, methylprednisolone aceponate.

Adventan emulsion is an anti-inflammatory medication (a corticosteroid) for use on the skin.

Adventan emulsion reduces inflammation and allergic reactions in the skin, and 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 emulsion is used in the treatment of acute forms of:

• Mild to moderate eczema related to an external cause, such as:
• • Allergic contact dermatitis.
  • Irritant contact dermatitis.
  • Nummular eczema.
  • Dyshidrotic eczema.
  • Unspecified eczema (eczema vulgaris).

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

Do not use Adventan emulsion:

• If you are allergic to the active ingredient methylprednisolone aceponate (MPA) or to any of the other components of this medication (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections, for example, chickenpox or herpes.
• In areas of the skin affected by inflammation that is red/pink (rosacea), ulcers, inflammation of the sebaceous glands (acne) or skin diseases with thinning of the skin (atrophy of the skin).(skin diseases).
• In areas of the skin showing a vaccine reaction, for example, redness or inflammation after the vaccine.
• In specific inflammation of the skin around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless they are treated properly with a specific medication).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Adventan emulsion.

Be especially careful if your doctor diagnoses, in addition, a bacterial or fungal skin infection; then, you must also use the additional treatment prescribed for the infection, because if not, the infection may worsen.

Corticosteroids, like the active ingredient MPA of Adventan emulsion, have significant effects on the body. It is not recommended to use Adventan emulsion in extensive areas of the skin or for prolonged periods, because this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects::

• Use it at the lowest possible dose.
• Use it only for the absolutely necessary time to relieve the skin condition.
• Adventan emulsion should not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (for example, the anal or genital area).
• Do not use Adventan emulsion in extensive areas of the skin (more than 40% of the body surface).
• Do not use Adventan emulsion under impermeable materials to air and water, including bandages, dressings, non-breathable clothing, or diapers, unless your doctor has prescribed it.

If you use Adventan emulsion for conditions other than those for which it has been prescribed, it may mask symptoms and make it difficult to diagnose and treat correctly.

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

Children

Use Adventan emulsion as little as possible to reduce the risk of adverse effects.

Do not use Adventan emulsion under impermeable materials to air and water, for example, diapers, unless your doctor has prescribed it.

Adventan emulsion 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.

Use of Adventan emulsion with other medications

No interactions of Adventan emulsion with other medications are known at this time.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased 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 intend to become pregnant, unless your doctor advises you to.

If your doctor recommends using Adventan emulsion during breastfeeding, do not apply the medication to the breasts; do not put the baby in contact with treated areas.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Adventan emulsion does not affect your ability to drive or operate machinery.

Adventan emulsion contains benzyl alcohol

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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, gently rubbing it in.
• Generally, the duration of treatment with Adventan emulsion should not exceed two weeks. Always make the treatment as short as possible.
• If you use Adventan emulsion for a skin eruption with inflammation (seborrheic eczema) and skin peeling on the face, do not treat it for more than one week.
• If the skin becomes too dry, please consult your doctor. You may need to apply a moisturizing regulating cream in addition.

Use in children

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

Adventan emulsion is not recommended for use in children under four months of age due to a lack of safety data.

If you use more Adventan emulsion than you should

No adverse effects are expected after a single overdose of Adventan emulsion (too large a quantity, too large an area of skin, or too frequent use). Repeated overdoses may cause 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 medication and the amount ingested).

If you forgot to use Adventan emulsion

Do not use a double dose to make up for the missed dose; if you have forgotten a dose, continue with your regular schedule as instructed by your doctor or as described in the leaflet.

If you interrupt treatment with Adventan emulsion

If you interrupt treatment with Adventan emulsion prematurely, the original symptoms of your skin problem may reappear. Please contact your doctor or pharmacist before interrupting treatment with Adventan emulsion.

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

Like all medicines, Adventan emulsion may cause side effects, although not everyone will experience 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 available data

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

• Uncommon:
• • Pain,
  • Itching,
  • Small blisters and pustules,
  • Peeling,
  • Superficial wounds (erosion),
  • Worsening or return of eczema,
  • Skin dryness.

The use of anti-inflammatory medications, called corticosteroids (such as the active ingredient in 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 hair follicles (folliculitis),
• Striae,
• Acne,
• Specific inflammation of the skin around the upper lip and chin (perioral dermatitis),
• Contact dermatitis (skin allergy),
• 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) is absorbed into the body through the skin. This, for example, may increase eye pressure (glaucoma).
• Blurred vision.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not store at a temperature above30°C.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Shelf life after first opening: 3 months

Medications should not be disposed of through drains or in the trash.Deposit containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Adventan emulsion

• The active principle is Methylprednisolone aceponate (MPA).
• The other components (excipients) are: medium-chain triglycerides, caprylic-capric-myristic-stearic triglyceride, 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 packaging

Adventan emulsion is a white skin emulsion (similar to an opaque milk cream) and is presented in tubes of:

• 20 g
• 50 g
• 100 g

The tube is provided with an extractable seal.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible for manufacturing:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria, Finland, Germany, Italy, Portugal: Advantan

Spain: Adventan

Last review date of this leaflet: July 2019

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