Advantan

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet! Information on the immediate packaging 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 a strong effect for topical use. After topical 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 found to be hypersensitive (allergic) 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

This 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 face, be careful and do not use an occlusive dressing. Using the medicine on the face may lead to skin atrophy more often 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 the use of systemic corticosteroids, there is a risk of developing glaucoma during treatment with Advantan cream (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 an 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 an occlusive dressing significantly increases the risk of systemic side effects characteristic of corticosteroids.
Avoid using an occlusive dressing. In children, diapers can act as an 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, use the medicine with caution - in the smallest possible doses for the shortest possible time. Do not use an occlusive dressing (e.g., diapers).

Advantan cream and other medicines

There are no reports of interactions between Advantan cream and other medicines.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, 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 or breastfeeding women after carefully weighing the benefits and risks of treatment.
Breastfeeding women should not use Advantan cream on the breast skin.
Avoid using the medicine on large areas of skin, for a long time, or under an occlusive dressing.

Driving and using machines

Advantan cream has no effect on the ability to drive or use machines.

Important information about some ingredients of Advantan cream

The excipients of Advantan cream, cetyl 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

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Advantan cream is for use on the skin only.
Usually, the medicine is applied in a thin layer to the affected skin once a day.
Do not use the medicine 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, consult your doctor.

Using more than the recommended dose of Advantan cream

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

Missing a dose of Advantan cream

If you miss a dose of the medicine at the scheduled time, use it 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 return after completing the treatment, consult your doctor.
If you have any further doubts about the use of the medicine, 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The most commonly observed side effects 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.
During topical use of products containing corticosteroids, systemic effects may occur due to their absorption through the skin.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Advantan cream

Store in a temperature 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 month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Advantan cream contains

• The active substance is methylprednisolone aceponate. 1 g of cream contains 1 mg of methylprednisolone aceponate.
• The other ingredients are: decyl oleate, glycerol monostearate, cetyl 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 contents of the pack

White to yellowish opaque cream.
Packaging:
Aluminum tube containing 15 g of cream, with an inner epoxy layer, with an HDPE screw 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
DK-2750 Ballerup, Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20090 Segrate (Milan)
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE 159327

Parallel import authorization number: 30/22 Date of approval of the leaflet: 12.01.2022

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