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, cream
Methylprednisolone aceponate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, 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 others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

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 IS ADVANTAN CREAM AND WHAT IS IT 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, pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (sweat rash), non-allergic eczema, eczema in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream

if the patient has hypersensitivity (allergy) to the active substance or to any of the other ingredients of Advantan cream
when the areas being 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
- skin ulcers
- local reactions following vaccination
in atrophic skin disorders.

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.
Local application of the cream may exacerbate local skin infections.
Contact of the cream with eyes, open wounds, and mucous membranes should be avoided.
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 cream to 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, prolonged use, or when applied under occlusive dressings or close to the eyes).
Treatment over large skin areas should be kept as short as possible.
Use on damaged skin, in skin folds, over large skin areas, prolonged use, or under occlusive dressings significantly increases the risk of systemic adverse effects typical of corticosteroids.
Occlusive (airtight) dressings should be avoided. In children, diapers may act as occlusive dressings. Conditions similar to those under occlusive dressings 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, Advantan cream should be used cautiously – in the smallest possible doses and for the shortest possible duration. Occlusive dressings (airtight, 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, breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Do not use the cream during the first trimester of pregnancy.
Your doctor may recommend using the cream 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 cream over large skin areas, for prolonged periods, or under occlusive dressings.
Driving and operating machinery
Advantan cream has no influence on the ability to drive or operate machinery.
Important information about certain excipients in Advantan cream
Excipients in Advantan cream: cetostearyl alcohol and butylated hydroxytoluene may cause skin reactions (e.g. contact dermatitis); butylated hydroxytoluene may additionally cause eye and mucous membrane irritation.

3. HOW TO USE ADVANTAN CREAM

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor or pharmacist. Advantan cream is intended for topical use on the skin only.
The cream should usually be applied in a thin layer to the affected skin area 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 a higher 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 you miss a dose at the scheduled time, apply the medicine as soon as possible.
Do not apply 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, 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 (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, 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 infection of the skin, cellulitis at the application site, swelling at the application site, irritation at the application site, pustular dermatitis, skin fissures, dilation of superficial blood vessels (telangiectasia), skin thinning (atrophy), acne.
Frequency unknown (frequency cannot be estimated from available data): striae, perioral dermatitis, skin discoloration, skin hypersensitivity reactions, excessive hair growth (hypertrichosis), blurred vision.
When topical corticosteroid products are used, systemic 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, tell 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 4921301, fax: +48 22 4921309, 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 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 indicated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS 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
White to yellowish opaque cream.
Packaging:
An aluminium tube with an internal epoxy coating, fitted with a cap made of HDPE, containing 15 g of cream,
packaged in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, 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 (MI), 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 Belgium, country of export: BE159327
Parallel import authorisation number: 164/22