Advantan

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Advantan, 1 mg/g, cream
Methylprednisolone aceponate
Please 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 necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Advantan cream is and what it is 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 Advantan cream is and what it is used for

Advantan cream contains the active substance methylprednisolone aceponate, which is a potent glucocorticoid for topical use. When applied locally to the skin, methylprednisolone aceponate exerts anti-inflammatory, antipruritic, and vasoconstrictive effects, leading to the resolution of symptoms such as erythema, swelling, exudation, itching, burning, and pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (heat rash), non-allergic rash, rash in children.

2. Important information before using Advantan cream

When not to use Advantan cream:

• if the patient has a known allergy (hypersensitivity) to the active substance or to any of the other ingredients of Advantan cream,
• when the areas to be treated present:
• skin infections caused by bacteria (e.g. tuberculous or syphilitic lesions) or fungi,
• lesions associated with viral diseases (e.g. shingles, chickenpox, etc.),
• rosacea,
• acne,
• perioral dermatitis,
• ulcers,
• local reactions after vaccination,
• atrophic skin disorders (atrophy).

Do not use in children under 2 years of age.
Warnings and precautions
Advantan cream should be used, especially in children, in the smallest possible dose and for the shortest possible duration.
If the physician determines that a bacterial or fungal skin infection is present, additional antibacterial or antifungal treatment should be applied.
Topical use of the medicine may exacerbate local skin infections.
Contact of the medicine with eyes, open wounds, and mucous membranes should be avoided.
If excessive skin dryness occurs during treatment with Advantan cream, it is advisable to switch to a preparation with higher fat content (e.g. Advantan emulsion or Advantan ointment).
When applying the medicine to facial skin, caution should be exercised and occlusive dressings should not be used. Application to the face may more frequently than on other body areas lead to skin atrophy.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has a history of glaucoma, this should be reported to the physician before using Advantan cream. As with systemic corticosteroids, treatment with Advantan cream carries a risk of developing glaucoma (e.g. when high doses are used, when applied over large skin areas, with prolonged use, or when applied under occlusive dressings or near the eyes).
Use over large skin areas should be kept as short as possible.
Application to damaged skin, skin folds, large skin areas, prolonged use, or use under occlusive dressings significantly increases the risk of systemic adverse effects typical of corticosteroids.
Occlusive dressings (sealed dressings) should be avoided. In children, diapers may act as occlusive dressings. Conditions similar to those under occlusive dressings may also occur in body areas prone to sweating (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 cautiously—using the smallest possible doses for the shortest possible time. Occlusive dressings (sealed dressings, e.g. diapers) should not be used.
Advantan cream and other medicines
There are no reported interactions between Advantan cream and other medicines.
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during the first trimester of pregnancy.
Your doctor may prescribe this medicine during pregnancy or breastfeeding only after carefully assessing the benefit-risk ratio.
Breastfeeding women should not apply Advantan cream to the skin of the breasts.
Avoid using the medicine over large skin areas, for prolonged periods, or under occlusive dressings.
Driving and operating machinery
Advantan cream has no effect on the ability to drive or operate machinery.
Important information about some of the ingredients of Advantan cream
Excipients of Advantan cream: cetostearyl alcohol and butylhydroxytoluene may cause skin reactions (e.g. contact dermatitis); butylhydroxytoluene may additionally cause eye and mucous membrane irritation.

3. How to use Advantan cream

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist. Advantan cream is intended for topical use on the skin only.
The cream is usually applied in a thin layer to the affected skin once daily.
Advantan cream should not be used in adults for longer 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 longer than 4 weeks.
If you feel that the effect of Advantan cream is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Advantan cream
There is no risk of acute poisoning after a single overdose applied to the skin (application over a large
skin surface under conditions of enhanced absorption) or after accidental ingestion of the medicine.
Missed dose of Advantan cream
If you miss a dose at the scheduled time, apply the medicine as soon as possible.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Advantan cream
If the original symptoms return after completion of treatment, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicinal product, Advantan cream may cause adverse reactions, although not everyone experiences them.
If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

The most commonly observed adverse reactions reported during clinical trials were:
burning and itching at the application site.

The following adverse reactions may occur during treatment with Advantan cream:

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, erythema at the application site, vesicles 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 product.

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, pyoderma (pyogenic skin infection), skin fissures, superficial blood vessel dilation (telangiectasia), skin thinning (atrophy), acne.

Frequency not known (frequency cannot be estimated from available data): striae (stretch marks), perioral dermatitis, skin discoloration, skin hypersensitivity reactions, excessive hair growth (hypertrichosis), blurred vision.

When topical corticosteroid products are used, systemic adverse effects may occur due to absorption through the skin.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Advantan cream

Store below 25°C.
Keep in a place out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with 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 is methylprednisolone aceponate. 1 g of cream contains 1 mg of methylprednisolone aceponate.
• Other ingredients: decyl oleate, glycerol monostearate, cetostearyl alcohol, solid fat, mixed triglycerides of fatty acids, macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, butylhydroxytoluene, purified water.

What Advantan cream looks like and contents of the pack
A white to yellowish, opaque cream.
Packaging:
Aluminium tube containing 15 g of cream, with an internal epoxy coating, fitted with a cap made of HDPE, in a cardboard carton.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Belgium, the country of export: BE 159327
Parallel import authorisation number: 30/22