ADVENTAN 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Adventan 1mg/g cream

Methylprednisolone aceponate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Adventan cream and what is it used for
2. What you need to know before you use Adventan cream
3. How to use Adventan cream
4. Possible side effects
5. Storing 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, and reactions associated with excessive cell multiplication (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:

• Acute eczema of mild to moderate severity related to an external cause, such as:
• • Allergic reaction to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to substances of habitual use, such as soap (irritant contact dermatitis).
  • Coin-shaped eruption (nummular eczema).
  • Itchy eruption on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin eruption with inflammation and scaling (seborrheic eczema).

This cream form is particularly indicated in exudative conditions (those that secrete fluid).

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

Do not use Adventan cream

• If you are allergic to 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).
• If you have rosacea (a condition that causes inflammation of the skin, red/pink), ulcers, acne, or skin diseases with skin thinning (atrophy).
• In areas of the skin that show a vaccination reaction, i.e., redness or inflammation after vaccination.
• In inflammation specific to the skin around the upper lip and chin (perioral dermatitis).
• In case of bacterial or fungal infections, see section "Warnings and precautions".
• It must not be used in the eyes or on open wounds.
• Not to be used in children under four months of age due to lack of experience.

Warnings and precautions

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

If your doctor diagnoses a bacterial or fungal infection, you should also use the additional treatment prescribed for the infection, because if you do not, 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 of Adventan, have significant effects on the body. It is not recommended to use Adventan on large areas of the skin or for extended periods, as this significantly increases the risk of side effects.

To reduce the risk of side effects:

• Use it at the lowest possible dose, especially in children.
• Use it only for the time strictly necessary to relieve the skin condition.
• Adventan cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the anal or genital area).
• It must not be used in skin folds, groin, or armpits.
• It must not be used under airtight and waterproof materials, including bandages (unless your doctor indicates otherwise), dressings, clothing, or diapers that are not very breathable.

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

If you apply Adventan cream 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 infection. Consult your doctor or pharmacist if you need more information.

Children

It is essential to note that diapers can be occlusive. If the doctor weighs the benefits and risks, Adventan cream may be prescribed for use in children between 4 months and 3 years.

Using Adventan cream with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

No interactions with other medicines are known for Adventan cream.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

To avoid any risk to the baby, do not use Adventan cream if you are pregnant or breast-feeding, unless your doctor tells you to.

If your doctor recommends using Adventan cream during breast-feeding, do not apply the medicine to the breasts; do not let the baby come into contact with treated areas.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

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

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

This medicine may cause eye and mucous membrane irritation because it contains 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 of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

Topical use.

• Apply Adventan cream in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the duration of treatment should not exceed 12 weeks. Always make the treatment as short as possible.
• Intermittent treatment is recommended when prolonged treatment is needed.
• If you use Adventan for a skin eruption with inflammation and scaling (seborrheic eczema) of the face, do not treat the affected areas for more than one week.

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

Use in children

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

The duration of treatment in children should be limited to the minimum, generally not exceeding 4 weeks.

If you use more Adventan cream than you should

No risk of acute intoxication is expected after single topical application of an overdose (application to a large area, under favorable conditions for absorption) or after accidental ingestion.

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 cream

Do not use a double dose to make up for forgotten doses. If you have forgotten a dose, continue with your usual schedule as indicated by your doctor or as described in the leaflet.

If you stop using Adventan cream

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

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

4. Possible side effects

Like all medicines, this medicine 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 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 and itching at the application site

• Uncommon:

Hypersensitivity to the active substance.

Blisters (bubbles), dryness, redness (erythema), inflammation of the hair follicle (folliculitis), eruptions, and abnormal skin sensation, such as numbness, tingling, or burning (paresthesia).

• Rare:

Fungal infection

Cracks in the skin, acne, infection with pus (pyoderma), dilated veins in the skin (telangiectasias), and skin thinning (atrophy).

Cellulitis, inflammation (edema), and irritation at the application site.

• Frequency not known:

Stretch marks on the skin, inflammation specific to the skin around the upper lip and chin (perioral dermatitis), skin discoloration, and allergic reactions on the skin.

Increased hair growth (hypertrichosis). Blurred vision.

Side effects may occur not only in the treated area but also in completely different parts of the body. This happens if the active substance (a corticosteroid) passes into the body through the skin. This, for example, can increase the pressure in the eye (glaucoma).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es.

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

5. Storing Adventan cream

Do not store above 25°C.

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

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

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 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 ingredients (excipients) are: decyl oleate, glycerol monostearate 40-50%, cetyl alcohol, hard fat, capric/caprylic/myristic/stearic triglycerides, polyoxyl 40 stearate, glycerol 85% (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321), and purified water.

Appearance and pack size

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

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

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/