PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Advantan, 1 mg/g (0.1%), cream
Methylprednisolone aceponate
Please read carefully all the information in this leaflet 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Advantan cream is and what it is used for
Important information before using Advantan cream
How to use Advantan cream
Possible side effects
How to store Advantan cream
Contents of the pack 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 relief of symptoms such as:
erythema, swelling, exudation, itching, burning, and pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (heat rash), non-allergic eczema,
eczema in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream

if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of Advantan
when the areas being treated have:
- 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 following vaccination
in atrophic skin disorders (atrophy).

Do not use in children under 2 years of age.
Warnings and precautions
Advantan 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 medication may exacerbate local skin infections.
Avoid contact of the medication with eyes, open wounds, and mucous membranes.
If excessive skin dryness occurs during treatment with Advantan cream, it is advisable to use a preparation with a higher fat content (e.g. Advantan emulsion or Advantan ointment).
When applying the medication to the facial skin, caution should be exercised and occlusive dressings should not be used. Application to the face may more frequently than elsewhere on the body lead to skin atrophy.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has previously had glaucoma, inform the physician before using Advantan cream. As with systemic corticosteroids, treatment with Advantan cream may carry a risk of developing glaucoma (e.g. when high doses are used, when applied over large skin areas or for prolonged periods, as well as when applied under occlusive dressings or near the eyes).
The use of the medication over large skin areas should be as short as possible.
Application over 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 intertriginous areas of the body (armpits, groin, skin folds, between fingers).
Children and adolescents
Do not use in children under 2 years of age.
In children over 2 years of age, the medication should be used cautiously—using the smallest possible doses for the shortest possible duration. Occlusive dressings (sealed dressings, e.g. diapers) should not be used.
Advantan and other medicines
There are no reports of interactions between Advantan cream and other medications.
Inform your doctor or pharmacist about all medications currently used or recently used, as well as any medications you plan to use.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.
Do not use the medication during the first trimester of pregnancy.
Your doctor may recommend using the medication during pregnancy or breastfeeding only after carefully weighing the risks versus benefits of treatment.
Breastfeeding women should not apply Advantan cream to the skin of the breasts.
Avoid using the medication over large skin areas, for prolonged periods, or under occlusive dressings.
Driving and operating machinery
Advantan has no effect on the ability to drive or operate machinery.
Important information about certain excipients in Advantan cream
Excipients in 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 as directed by the physician. If in doubt, consult
your doctor or pharmacist. Advantan cream is intended for topical use on the skin only.
Usually, the medicine should be applied as a thin layer to the affected skin area once daily.
Do not use this medicine 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 a larger than 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 a dose is missed at the scheduled time, apply the medicine as soon as possible.
Do not use a double dose to make up for a missed dose.
Discontinuation of Advantan cream
If the original symptoms recur after completion of treatment, consult your doctor.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Advantan cream may cause adverse reactions, although not everyone experiences them.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, consult a doctor or pharmacist.

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

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

Common (occurs in 1 to 10 people out of 100): burning at the application site, itching at the application site.

Uncommon (occurs in 1 to 10 people out of 1,000): dryness of the skin at the application site, redness (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 medicine.

Rare (occurs in 1 to 10 people out of 10,000): fungal skin infection, cellulitis at the application site, swelling at the application site, irritation at the application site, pustular skin inflammation, 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.

With topical corticosteroid products, systemic adverse effects may occur as a result of absorption through the skin.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE ADVANTAN CREAM

Store below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
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 PACKAGE 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 are: decyl oleate, glycerol monostearate 40-55%, cetostearyl alcohol, solid fat, mixed triglycerides of fatty acids (Softisan 378), macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, butylated hydroxytoluene, purified water.

What Advantan cream looks like and contents of the pack
White to yellowish, opaque cream.
Packaging:
Aluminium tube internally coated with epoxy resin, with a protective membrane and a cap made of HDPE, containing 15 g or 30 g of cream, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Greece, country of export: 69049/12/28-01-2013
Parallel Import Authorisation Number: 148/18