Adventan 1 mg/g cutaneous emulsion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adventan 1mg/g cutaneous emulsion

Methylprednisolone aceponate

Package leaflet contents:

1. What Adventan emulsion is 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. How to store Adventan emulsion
6. Contents of the pack and other information

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

Adventan emulsion contains the active substance, methylprednisolone aceponate.

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

Adventan emulsion reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive proliferation 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 to treat acute forms of:

• Mild to moderate rash (eczema) related to external causes, such as:

  • Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to substances commonly used, for example, soap (irritant contact dermatitis).
  • Coin-shaped 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).

2. What you need to know before using Adventan emulsion

Do not use Adventan emulsion:

• If you are allergic to the active substance 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, for example, chickenpox or herpes.
• On areas of skin affected by red/pink inflammation (rosacea), ulcers, sebaceous gland inflammation (acne), or skin diseases associated with thinning of the skin (atrophic skin diseases).
• On areas of skin showing a vaccination 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 medicine).

Warnings and precautions

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

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

Anti-inflammatory drugs (corticosteroids), such as the active substance MPA in Adventan emulsion, have significant effects on the body. The use of Adventan emulsion 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.
• Use it only for the shortest time necessary to relieve the skin condition.
• Adventan emulsion must not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (for example, the anal or genital area).
• Adventan emulsion must not be used on extensive areas of skin (more than 40% of body surface area).
• Adventan emulsion must not be used under air- and water-impermeable materials, including bandages, dressings, non-breathable clothing, or diapers, unless specifically prescribed by your doctor.

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

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 for protection against sexually transmitted infections, such as HIV. Consult your doctor or pharmacist if you need further information.

Children

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

Adventan emulsion must not be used under air- and water-impermeable materials, such as diapers, unless specifically prescribed by your doctor.

Adventan emulsion 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.

Using Adventan emulsion with other medicines

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

To avoid any risk to the child, do not use Adventan emulsion if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, unless your doctor has instructed you to do so.

If your doctor recommends using Adventan emulsion 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 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 operate machinery.

Adventan emulsion contains benzyl alcohol

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

3. How to use Adventan emulsion

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

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

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

Use in children

Adventan emulsion may be used in children between 4 months and 3 years of age if prescribed by your doctor. No dose adjustments are required.

The use of Adventan emulsion is not recommended in children under four 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 large amount, too large skin area, or too frequent use). Repeated overdoses may cause side 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 telephone (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 missed doses; if you have forgotten a dose, continue with your regular schedule as instructed by your doctor or as described in this leaflet.

If you stop using Adventan emulsion

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

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

4. Possible adverse effects

Like all medicines, Adventan emulsion may cause adverse effects, although not everyone experiences them.

The assessment of adverse effects is based on the following frequency categories:

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:

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

• Uncommon:

  • Pain,
  • Itching,
  • Small blisters and pustules,
  • Skin peeling (desquamation),
  • Superficial skin lesions (erosion),
  • Worsening or recurrence of eczema,
  • Skin cracking.

The use of anti-inflammatory drugs known as corticosteroids (such as the active substance in Adventan emulsion) on the skin may lead to the following adverse effects (frequency not known):

• Thinning of the skin (atrophy),
• Dry skin,
• Redness (erythema),
• Appearance of red spots,
• Inflammation of hair follicles (folliculitis),
• Stretch marks (striae),
• Acne,
• Specific skin inflammation around the upper lip and chin (perioral dermatitis),
• Skin allergic 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 type 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 through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Validity period after first opening: 3 months

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at 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 emulsion

• The active substance 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 medicinal product and contents of the container

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 is provided with a removable seal.

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

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

Austria, Finland, Germany, Italy, Portugal: Advantan

Spain: Adventan

Date of the most recent revision of this leaflet: July 2019

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