Advantan

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Advantan
1 mg/g (0.1%), cream
Methylprednisolone aceponate
Please read the entire leaflet carefully before using this 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. This medicine may harm others, 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, which is a potent glucocorticoid intended for topical use. When applied topically to the skin, methylprednisolone aceponate exerts anti-inflammatory, antipruritic, and vasoconstrictive effects, leading to the resolution of symptoms such as redness, 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 any of the other ingredients of Advantan cream
• when the areas to be treated have:
• bacterial (e.g. tuberculous or syphilitic lesions) or fungal skin infections,
• changes caused by viral diseases (e.g. shingles, chickenpox, etc.),
• rosacea,
• acne,
• perioral dermatitis,
• ulcers,
• local reactions after vaccination,
• skin atrophy.

Do not use in children under 2 years of age.
Warnings and precautions

Advantan cream should be used in the smallest possible dose for the shortest possible time, especially in children.
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 medicine may worsen local skin infections.
Avoid contact of the cream with eyes, open wounds, and mucous membranes.
If excessive skin dryness occurs during treatment with Advantan cream, it is recommended to use a preparation with a higher fat content (e.g. Advantan emulsion or Advantan ointment).
When applying the cream to the face, caution should be exercised and occlusive dressings should not be used. Application to facial skin may more frequently than application to other body areas lead to skin atrophy.
If blurred vision or other visual disturbances occur, consult a physician.
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, 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 dressing significantly increases the risk of systemic adverse effects typical of corticosteroids.
Avoid using occlusive dressings (sealed). In children, diapers may have a similar effect to occlusive dressings. Conditions similar to those caused by occlusive dressings may also occur in body folds (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 cream should be used with caution – in the smallest possible doses for the shortest possible time. Occlusive dressings (sealed, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
Your doctor may prescribe the medicine to 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 or operate machinery.

Important information about some ingredients of 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 exactly as directed by the doctor. In case of doubts, consult
your doctor or pharmacist. Advantan cream is intended for external use on the skin only.
Usually, the medicine should be applied as 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 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 side effects

Like all medicines, Advantan cream may cause side effects, although not everybody gets them.
If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

The most commonly observed side effects reported during clinical trials were:
burning and itching at the application site.

The following side effects 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, blisters 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 infection of the skin, cellulitis at the application site, swelling at the application site, irritation at the application site, pustular rash, skin fissures, dilation of superficial blood vessels (telangiectasia), thinning of the skin (atrophy), acne.

Frequency not known (frequency cannot be estimated from the available data): stretch marks (striae), perioral dermatitis, skin discolouration, skin hypersensitivity reactions, excessive hair growth (hypertrichosis), blurred vision.

When topical corticosteroid products are used, systemic side effects may occur as a result of absorption through the skin.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.

5. How to store Advantan cream

Do not store above 25°C.
Keep the medicine 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 packaging 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, butylhydroxytoluene, purified water.

What Advantan cream looks like and contents of the pack
White to yellowish, opaque cream.
Packaging:
An aluminium tube internally coated with epoxy resin, with a protective membrane and a cap made of HDPE, containing 15 g of cream, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the 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
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 Greece, the country of export: 103475/28-11-2019
69049/12/28-01-2013
Parallel import authorisation number: 316/15