Advantan

Warning! Keep the package leaflet, information on the immediate packaging in a foreign language!
Advantan
1 mg/g, cream
Methylprednisolone aceponate
Please read the leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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 for topical use. When applied topically to the skin, methylprednisolone aceponate exerts anti-inflammatory, antipruritic, and vasoconstrictive effects, leading to the relief of symptoms such as redness, swelling, exudation, itching, burning, and pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (heat rash), non-allergic eczema, infantile eczema.

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 components 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. herpes zoster, varicella, 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
The medicine should be used in the smallest possible dose for the shortest possible duration, especially in children.
If the doctor 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.
Avoid contact of the medicine with the eyes, open wounds, and mucous membranes.
If excessive skin dryness occurs during treatment with Advantan cream, it is advisable to use a preparation with higher fat content (e.g. Advantan emulsion or Advantan ointment). When applying the medicine to the face, caution is required and occlusive dressings should not be used. Application to the facial skin may more frequently lead to skin atrophy than when applied to other body areas.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has a history of glaucoma, inform the doctor 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, treatment is prolonged, or when the medicine is applied under occlusive dressing or near the eyes).
Treatment of large skin areas should be as short as possible.
Use on damaged skin, in skin folds, on large skin areas, prolonged use, or use under occlusive dressing significantly increases the risk of systemic adverse effects typical of corticosteroids.
Avoid using occlusive dressings (sealed dressings). In children, diapers may act as occlusive dressings. Conditions similar to those after occlusive dressings occur also in intertriginous areas (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 medicine should be used cautiously – in the smallest possible doses for the shortest possible time. Do not use occlusive dressings (sealed dressings, e.g. diapers).

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 currently used or recently used, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
The doctor may recommend using the medicine in pregnant or breastfeeding women only after careful assessment of the risk-benefit ratio.
Breastfeeding women should not apply Advantan cream to the skin of the breasts.
Avoid using the medicine on large skin areas, prolonged use, or use under occlusive dressing.

Driving and operating machinery
Advantan cream has no effect 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 according to the doctor's instructions. If in doubt, consult your doctor or pharmacist. Advantan cream is intended for topical use on the skin only.
Usually, a thin layer of the cream should be applied once daily to the affected skin area. Do not use 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 the effect of Advantan cream seems 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 to large skin areas under conditions of increased 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 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 regarding the use of the medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Advantan cream may cause adverse reactions, although not everybody experiences them.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
The most commonly observed adverse reactions reported in clinical trials were: burning and itching at the application site.
During treatment with Advantan cream, the following adverse reactions may occur:
Common (occurs in 1 to 10 people out of 100): burning at application site, itching at application site.
Uncommon (occurs in 1 to 10 people out of 1,000): dryness of skin at application site, erythema at application site, vesicles at application site, folliculitis at application site, rash at application site, tingling and numbness at application site (paresthesia), hypersensitivity to the medicine.
Rare (occurs in 1 to 10 people out of 10,000): fungal skin infection, cellulitis at application site, swelling at application site, irritation at application site, pyoderma, skin fissures, superficial blood vessel dilation (telangiectasia), skin thinning (atrophy), acne.
Frequency not known (frequency cannot be estimated from available data): striae, perioral dermatitis, skin discoloration, skin hypersensitivity reactions, hypertrichosis, blurred vision.
With topical use of corticosteroid-containing products, systemic effects may occur due to absorption through the skin.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Store below 25°C.
Keep 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps 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: decyl oleate, glycerol monostearate, cetostearyl alcohol, solid fat, mixed fatty acid triglycerides, 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.
Pack:
Aluminium tube internally coated with an epoxy resin and externally with a polyester layer; with a protective membrane and closure cap made of HDPE, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity 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
I-20054 Segrate (MI)
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Belgium marketing authorization number (country of export): BE159327
Parallel import authorization number: 37/24