Advantan

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

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

Advantan

1 mg/g (0.1% w/w), cream

Methylprednisolone aceponate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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, pharmacist, or nurse. 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 packaging 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, antipruritic, 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 related to 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 excessive drying of the skin occurs 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 skin of the face, caution should be exercised and occlusive dressing should not be used. Using the medicine on the skin of 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 doctor should be informed 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 the medicine on large areas of skin or for a long time, as well as after applying the medicine under occlusive dressing or on 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 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.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
Your doctor may recommend using the medicine in pregnant women and breastfeeding mothers, after carefully weighing the risk-benefit ratio.
Breastfeeding women should not use Advantan cream on the breast skin.
Using the medicine on large areas of skin, for a long time, or under occlusive dressing should be avoided.

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 your doctor. In case of doubts, you should consult your doctor or pharmacist. Advantan cream is intended for local 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 you feel that the effect of Advantan cream is too strong or too weak, you should consult your doctor.

Using a higher dose of Advantan cream than recommended

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

Missing a dose of Advantan cream

In case of missing a dose of the medicine at the scheduled time, you should use the medicine as soon as possible.
Do not use a double dose to make up for the missed dose.

Stopping the use of Advantan cream

In case of recurrence of the initial symptoms of the disease after completing the treatment, you should contact your doctor.
In case of any further doubts related to the use of the medicine, you should consult your 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 you notice any side effects not listed in this leaflet, you should tell your 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 people in 100):burning at the application site, itching at the application site.
Uncommon (affects 1 to 10 people 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 people 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.
During local use of products containing corticosteroids, systemic effects may occur due to their absorption through the skin.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ADVANTAN CREAM

Do not store above 25°C.
Keep the medicine 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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGING 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: cetostearyl alcohol, butylhydroxytoluene, decyl oleate, glycerol monostearate 40-55, solid fat, triglyceride mixture of fatty acids (Softisan 378), macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, purified water.

What Advantan cream looks like and what the packaging contains

White to yellowish opaque cream.
Packaging:
Aluminum tube containing 15 g of cream, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, 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
20054 Segrate, Milan
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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Marketing authorization number in Greece, the country of export: 103475/28-11-2019
69049/28-01-2013
Parallel import authorization number: 148/19

Date of leaflet approval: 12.04.2024

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