Advantan

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Advantan

1 mg/g, cream

Methylprednisolone aceponate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Advantan cream and what is it used for
• 2. Important information before using Advantan cream
• 3. How to use Advantan cream
• 4. Possible side effects
• 5. How to store Advantan cream
• 6. Contents of the pack and other information

1. WHAT IS ADVANTAN CREAM AND WHAT IS IT USED FOR

Advantan cream contains the active substance methylprednisolone aceponate, which is a glucocorticoid with strong local effect. After local application to the skin, methylprednisolone aceponate has anti-inflammatory, anti-itching, and vasoconstrictive effects, causing the disappearance of symptoms such as redness, swelling, exudation, itching, burning, and pain.

Indications for use

Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, intertrigo, non-allergic eczema, eczema in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream:

• if the patient has been diagnosed with hypersensitivity (allergy) to the active substance or any of the other ingredients of Advantan cream
• when the treated areas have
• bacterial skin infections (e.g., tuberculous or syphilitic lesions) or fungal infections
• changes associated with viral diseases (e.g., shingles, chickenpox, and others)
• rosacea
• acne
• perioral dermatitis
• ulcers
• local reactions after vaccination
• in atrophic skin diseases

Do not use in children under 2 years of age.

Warnings and precautions

The medicine, especially in children, should be used in the smallest possible dose for the shortest possible time.
If the doctor finds that a bacterial or fungal skin infection has occurred, they will also use anti-bacterial or anti-fungal treatment.
Local use of the medicine may exacerbate local skin infections.
Avoid contact of the medicine with the eyes, open wounds, and mucous membranes.
If the skin becomes excessively dry during the use of Advantan cream, it is recommended to use a medicine with a higher fat content (e.g., Advantan emulsion or Advantan ointment). When using the medicine on the face, caution should be exercised and occlusive dressing should not be used. Using the medicine on the face may lead to skin atrophy more frequently than when used on other areas of the body.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If there have been cases of glaucoma in the past, the patient should inform their doctor before using Advantan cream. Similarly, as with systemic corticosteroids, during treatment with Advantan cream, there is a risk of developing glaucoma (e.g., when using large doses of the medicine or using it on large areas of skin or for a long time, as well as after applying the medicine under occlusive dressing or on the skin close to the eyes).
Using the medicine on large areas of skin should be for the shortest possible time.
Using the medicine on damaged skin, in skin folds, on large areas of skin, for a long time, or under occlusive dressing significantly increases the risk of systemic side effects characteristic of corticosteroids.
Occlusive dressing (sealing) should be avoided. In children, diapers can play the role of occlusive dressing. Conditions similar to those after using occlusive dressings also occur in intertriginous areas of the body (armpits, groin, skin folds, skin between the fingers).

Children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, the medicine should be used with caution - in the smallest possible doses for the shortest possible time. Occlusive dressing (sealing, e.g., diapers) should not be used.

Advantan cream and other medicines

There are no reports of interactions between Advantan cream and other medicines.
The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine should not be used during the first trimester of pregnancy.
The doctor may recommend using the medicine in pregnant women and breastfeeding mothers, after carefully assessing the risk-benefit ratio.
Breastfeeding women should not use Advantan cream on the breast skin.
The medicine should be avoided on large areas of skin, for a long time, or under occlusive dressing.

Driving and using machines

Advantan cream does not affect the ability to drive and use machines.

Important information about some ingredients of Advantan cream:

The excipients of Advantan cream, cetostearyl alcohol and butylhydroxytoluene, may cause skin reactions (e.g., contact dermatitis); butylhydroxytoluene may also cause eye and mucous membrane irritation.

3. HOW TO USE ADVANTAN CREAM

This medicine should always be used as directed by the doctor. If in doubt, consult a doctor or pharmacist. Advantan cream is for external use on the skin only.
Usually, the medicine is applied in a thin layer to the affected skin once a day. The medicine should not be used in adults for more than 12 weeks.

Use in children

Do not use in children under 2 years of age.
In children over 2 years of age, do not use for more than 4 weeks.
If the patient feels that the effect of Advantan cream is too strong or too weak, they should consult their doctor.

Using a higher dose of Advantan cream than recommended

There is no risk of acute overdose after a single overdose of the medicine on the skin (use on a large area of skin in conditions of increased absorption) or after accidental ingestion of the medicine.

Missing a dose of Advantan cream

If a dose of the medicine is missed at the scheduled time, it should be used as soon as possible. Do not use a double dose to make up for the missed dose.

Stopping the use of Advantan cream

If the initial symptoms of the disease recur after completing the treatment, the patient should contact their doctor.
If there are any further doubts about the use of the medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Advantan cream can cause side effects, although not everybody gets them.
If any of the side effects get worse or if any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.
The most common side effects observed during clinical trials were burning and itching at the application site.
During treatment with Advantan cream, the following side effects may occur:
Common (affects 1 to 10 users in 100):burning at the application site, itching at the application site.
Uncommon (affects 1 to 10 users in 1,000):dryness of the skin at the application site, redness at the application site, blisters at the application site, folliculitis at the application site, rash at the application site, tingling and numbness at the application site (paresthesia), hypersensitivity to the medicine.
Rare (affects 1 to 10 users in 10,000):fungal skin infection, cellulitis at the application site, swelling at the application site, irritation at the application site, purulent skin infection, skin cracks, superficial vessel dilatation (telangiectasia), skin thinning (atrophy), acne.
Frequency not known (frequency cannot be estimated from the available data):skin stretch marks, perioral dermatitis, skin discoloration, skin hypersensitivity reactions, excessive hair growth, blurred vision.
When using topical corticosteroid products, systemic effects may occur due to their absorption through the skin.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE ADVANTAN CREAM

Store below 25°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Advantan cream contains

• The active substance of the medicine is methylprednisolone aceponate. 1 g of cream contains 1 mg of methylprednisolone aceponate.
• The medicine also contains: decyl oleate, glycerol monostearate, cetostearyl alcohol, solid fat, triglyceride mixture of fatty acids, macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, butylhydroxytoluene, purified water.

What Advantan cream looks like and what the pack contains

White to yellowish opaque cream.
Packaging:
Aluminum tube internally coated with epoxy resin and externally coated with a polyester layer; with a protective membrane and an HDPE cap, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
I-20054 Segrate (MI)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE159327
Parallel import authorization number: 37/24

Date of approval of the leaflet: 25.01.2024

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