Adventan 1 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adventan 1mg/g ointment

Methylprednisolone aceponate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Adventan ointment 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 ointment 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 commonly used substances such as, for example, soap (irritant contact dermatitis).
  • Coin-shaped rash (nummular eczema).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (discoid eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).

This ointment form is particularly indicated for very dry conditions.

2. What you need to know before using Adventan ointment

Do not use Adventan ointment

• 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 (for example, chickenpox or herpes).
• If you have rosacea (a condition causing red/pink skin inflammation), ulcers, acne, or skin diseases 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.
• In 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 ointment.

If your doctor also diagnoses a bacterial or fungal infection, you must also use any additional treatment prescribed 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 substance MPA in Adventan, have significant effects on the body. The use of Adventan on large areas of skin or for prolonged periods is not recommended, as this substantially 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 ointment must not come into contact with the eyes, mouth, open wounds, or mucous membranes (for example, the anal or genital area).
• Must not be used in skin folds, groin, or armpits.
• Must not be used under 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 ointment 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 infections, such as HIV infection. Consult your doctor or pharmacist if you need further information.

Children

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

Using Adventan ointment with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may 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 ointment if you are pregnant or breastfeeding, unless your doctor instructs you to do so.

If your doctor recommends using Adventan ointment during breastfeeding, do not apply the medicine to the breasts and avoid contact of the infant with treated areas.

Driving and using machines

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

Adventan ointment contains hydrogenated castor oil.

This medicine may cause skin reactions because it contains hydrogenated castor oil.

3. How to use Adventan ointment

Follow exactly the instructions given to you by your doctor.

If in doubt, consult your doctor or pharmacist again.

Unless otherwise directed by your doctor, the recommended dose is:

Cutaneous use

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

Use in children

Adventan ointment 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, in general, should not exceed 4 weeks.

If you use more Adventan ointment than you should

Acute intoxication is not expected following 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 medication and the amount ingested).

If you forget to use Adventan ointment

Do not use a double dose to make up for forgotten 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 ointment

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

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 can 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 the available data)

• Common
  Burning sensation at the application site and inflammation of hair follicles (folliculitis).

• Uncommon
  Dilated small blood vessels in the skin (telangiectasias), skin cracks, itching, pain, blisters (vesicles), pustules (acne-like pimples), and papules (small bumps) at the application site.

• Frequency not known
  Hypersensitivity to the active substance
  Acne, thinning of the skin (atrophy), stretch marks on the skin, specific skin inflammation around the upper lip and chin (perioral dermatitis), skin discoloration, and allergic skin reactions.
  Excessive 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 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 via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es.

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

5. Storage of Adventan 1 mg/g ointment

Do not store above 30°C.

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

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Adventan ointment

• The active substance is Methylprednisolone aceponate (MPA). Each g of ointment contains 1 mg of methylprednisolone aceponate (0.1%).
• The other components (excipients) are: white paraffin (semi-solid), liquid paraffin, microcrystalline wax, hydrogenated castor oil.

Appearance of the product and contents of the container

Adventan ointment is a translucent white to slightly yellowish ointment and is supplied in tubes of 30 and 60 g.

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 review of this summary: January 2020

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