Advantan

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Advantan
1 mg/g (0.1% w/w), cream
Methylprednisolone aceponate
Please read the entire leaflet carefully before using this 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. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 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 intended 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, edema, exudation, pruritus, burning, and pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria rash (prickly heat), non-allergic eczema, eczema in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream:

• if the patient has a known hypersensitivity (allergy) to the active substance or to any of the other ingredients of Advantan cream
• when the areas to be treated show
• 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
• atrophic skin disorders (atrophy)

Do not use in children under 2 years of age.
Warnings and precautions
Advantan cream should be used in the smallest possible dose and for the shortest possible duration, especially in children.
If the physician determines that a bacterial or fungal skin infection is present, additional antibacterial or antifungal treatment should be applied.
Topical application of the cream may exacerbate existing local skin infections.
Contact of the cream with the eyes, open wounds, and mucous membranes should be avoided.
If excessive skin dryness occurs during treatment with Advantan cream, it is recommended to use a preparation with higher fat content (e.g. Advantan emulsion or Advantan ointment). When applying the cream to the facial skin, caution should be exercised and occlusive dressings should not be used. Application to the face may more frequently lead to skin atrophy than when applied to other areas of the body.
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 may carry a risk of developing glaucoma (e.g. when high doses are used, large skin areas are treated, prolonged treatment is required, or when the cream is applied under occlusive dressing or near the eyes).
Treatment over large skin areas should be 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 (airtight) dressings should be avoided. In children, diapers may act as occlusive dressings. Conditions similar to those occurring 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, Advantan cream should be used with caution – in the smallest possible doses and for the shortest possible duration. Occlusive dressings (e.g. diapers) should not be used.
Advantan cream and other medicines
There are no reports of interactions between Advantan cream and other medicines.
Inform your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use this medicine during the first trimester of pregnancy.
A doctor may recommend using this medicine during pregnancy or breastfeeding only after careful assessment of the benefit-risk ratio.
Breastfeeding women should not apply Advantan cream to the skin of the breasts.
Avoid using the cream on 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 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 prescribed by your doctor. If in doubt, consult your
doctor or pharmacist. Advantan cream is intended for topical use on the skin only.
Usually, the cream should be applied as 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 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 increased 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 the 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 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 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 (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 (paraesthesia), 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, pustular rash, skin cracking, telangiectasia (dilation of superficial blood vessels), skin atrophy (thinning), acne.
Frequency not known (frequency cannot be estimated from the available data): striae (stretch marks), perioral dermatitis, skin discoloration, skin hypersensitivity reactions, hypertrichosis (excessive hair growth), blurred vision.

During topical use of corticosteroid-containing products, 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, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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
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 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer in use. 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: cetostearyl alcohol, butylhydroxytoluene, decyl oleate, glycerol monostearate 40-55, solid fat, mixed triglycerides of fatty acids (Softisan 378), macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, purified water.

What Advantan cream looks like and contents of the pack
White to yellowish opaque cream.
Packaging:
Aluminium tube containing 15 g of cream, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Greece, 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 authorisation numbers in Greece, country of export: 103475/28-11-2019
69049/28-01-2013
Parallel import licence number: 148/19