Advantan

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Advantan (Lexxema)
1 mg/g, cream
Methylprednisoloni aceponas
Advantan and Lexxema are different trade names for the same medicinal product.
Please read the leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 someone else, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any 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, 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 rash, 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 to the active substance or to any of the other ingredients of Advantan cream,
• when the areas to be treated have:
• skin infections caused by bacteria (e.g. tuberculous or syphilitic lesions) or fungi,
• lesions associated with viral diseases (e.g. herpes zoster, 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
The medicine 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.
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 a higher fat content (e.g. Advantan emulsion or Advantan ointment).
When applying the medicine to the facial skin, caution should be exercised and occlusive dressings should not be used. Application to the face may more frequently than application to 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, 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, or after application under occlusive dressings or near the eyes).
Application 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 use under occlusive dressings significantly increases the risk of systemic adverse effects typical of corticosteroids.
Avoid using occlusive (occluding) dressings. In children, diapers may have a similar effect to occlusive dressings. Conditions similar to those following 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 medicine should be used cautiously—using the smallest possible doses for the shortest possible time. Occlusive dressings (occluding, 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 currently used or recently used, as well as any medicines planned for future 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 the medicine during the first trimester of pregnancy.
A physician may recommend use of the medicine in pregnant or breastfeeding women 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 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 vehicles or operate machinery.
Important information about certain 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 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 in a thin layer to the affected area of skin once daily.
Advantan 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 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 following 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 cream 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 return after completion of treatment, contact your doctor.
If you have any further doubts regarding 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 will experience 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 during clinical trials were:
burning and itching at the application site.

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

Common (may affect 1 to 10 people in 100): burning at the application site, itching at the application site.

Uncommon (may affect 1 to 10 people 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 medicine.

Rare (may affect 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 fissures, telangiectasia (dilation of superficial blood vessels), skin atrophy (thinning of the skin), acne.

Frequency not known (frequency cannot be estimated from available data): striae (stretch marks), perioral dermatitis, skin discoloration, skin hypersensitivity reactions, hypertrichosis (excessive hair growth), 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 the medicine.

5. HOW TO STORE ADVANTAN CREAM

Do not store at temperatures above 25°C.
Keep in a place invisible and inaccessible to 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 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 are: decyl oleate, glyceryl monostearate, cetostearyl alcohol, solid fat, mixed fatty acid triglycerides (Softisan 378), macrogol stearate, glycerol 85% (E 422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E 321), purified water.

What Advantan cream looks like and contents of the pack
A white, opaque cream.
Pack:
An aluminium tube containing 30 g of cream, placed in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Italfarmaco, S.A.
San Rafael, 3
28108 Alcobendas (Madrid)
Spain
Manufacturer:
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering, 21
20054 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 Spain, the country of export: 887976.2
Parallel Import Authorisation Number: 61/25