Advantan

PATIENT LEAFLET: INFORMATION FOR THE USER

Advantan,1 mg/g, cream
(Methylprednisolone aceponate)

Table of Contents of the Leaflet

• 1. What is Advantan cream and what is it 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 IS ADVANTAN CREAM AND WHAT IS IT USED FOR

Advantan cream contains the active substance methylprednisolone aceponate, which is a
glucocorticoid with strong local effect. After local application to the skin, methylprednisolone aceponate
has anti-inflammatory, antipruritic, and vasoconstrictive effects, causing the disappearance of symptoms
such as redness, swelling, exudation, itching, burning, and pain.

Indications for use

Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, intertrigo, non-allergic eczema, eczema
in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream:

• when the treated areas have
• bacterial skin infections (e.g. tuberculous or syphilitic lesions) or fungal infections
• changes related to viral diseases (e.g. shingles, chickenpox, etc.)
• rosacea
• acne
• perioral dermatitis
• ulcers
• local reactions after vaccination
• in atrophic skin diseases

Do not use in children under 2 years of age.

Warnings and precautions

The medicine, especially in children, should be used in the smallest possible dose for the shortest possible time.
If the doctor finds that a bacterial or fungal skin infection has occurred, additional antibacterial or antifungal treatment will be applied.
Local use of the medicine may exacerbate local skin infections.
Avoid contact of the medicine with the eyes, open wounds, and mucous membranes.
If excessive drying of the skin occurs during the use of Advantan cream, it is recommended to use a medicine with a higher fat content (e.g. Advantan ointment or Advantan emulsion).
When using the medicine on the face, caution should be exercised and occlusive dressing should not be used. Using the medicine on the face may lead to skin atrophy more frequently than when used on other areas of the body.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If there have been cases of glaucoma in the past, the doctor should be informed before using Advantan cream. Similarly, as with systemic corticosteroids, during treatment with Advantan cream, there is a risk of developing glaucoma (e.g. when using large doses of the medicine or using the medicine on large areas of skin or for a long time, as well as after applying the medicine under occlusive dressing or on the skin near the eyes).
Using the medicine on large areas of skin should be as short as possible.
Using the medicine on damaged skin, in skin folds, on large areas of skin, for a long time, or under occlusive dressing significantly increases the risk of systemic side effects characteristic of corticosteroids.
Occlusive dressing (sealing) should be avoided. In children, diapers can act as an occlusive dressing. Conditions similar to those after applying occlusive dressings also occur in intertriginous areas of the body (armpits, groin, skin folds, skin 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 with caution - in the smallest possible doses for the shortest possible time. Occlusive dressing (sealing, e.g. diapers) should not be used.

Advantan and other medicines

There are no reports of interactions between Advantan cream and other medicines.
The doctor or pharmacist should be informed about all medicines used by the patient currently or recently, as well as about medicines that the patient plans to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine should not be used during the first trimester of pregnancy.
The doctor may recommend using the medicine in pregnant women and breastfeeding mothers, after carefully assessing the risk-to-benefit ratio of treatment.
Breastfeeding women should not use Advantan cream on the breast skin.
The medicine should be avoided on large areas of skin, for a long time, or under occlusive dressing.

Driving and using machines

Advantan has no effect on the ability to drive and use machines.

Important information about some ingredients of Advantan cream:

Excipients of Advantan cream: cetyl alcohol and butylhydroxytoluene may cause skin reactions (e.g. contact dermatitis); butylhydroxytoluene may also cause eye and mucous membrane irritation.

3. HOW TO USE ADVANTAN CREAM

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. Advantan cream is intended for local use on the skin only.
Usually, the medicine is applied in a thin layer to the affected skin once a day.
The medicine should not be used in adults for more 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 more than 4 weeks.
If it is felt that the effect of Advantan cream is too strong or too weak, the doctor should be consulted.

Using a higher dose of Advantan cream than recommended

There is no risk of acute poisoning after a single overdose of the medicine on the skin (application to a large area of skin in conditions of increased absorption) or after accidental ingestion of the medicine.

Missing a dose of Advantan cream

In case of missing a dose of the medicine at the scheduled time, the medicine should be applied as soon as possible.
A double dose should not be used to make up for the missed dose.

Stopping the use of Advantan cream

In case of recurrence of the initial disease symptoms after completing the treatment, the doctor should be contacted.
In case of any further doubts related to the use of the medicine, the doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Advantan cream can cause side effects, although not everybody gets them.
If any of the side effects get worse or if any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.
The most common side effects observed during clinical trials were: burning and itching at the application site.
During treatment with Advantan cream, the following side effects may occur:
Common (occurs in 1 to 10 users in 100):burning at the application site, itching at the application site.
Uncommon (occurs in 1 to 10 users in 1,000):dryness of the skin at the application site, redness 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 (paresthesia), hypersensitivity to the medicine.
Rare (occurs in 1 to 10 users in 10,000):fungal skin infection, cellulitis at the application site, swelling at the application site, irritation at the application site, purulent skin infection, skin cracks, superficial vessel dilatation (telangiectasia), skin thinning (atrophy), acne.
Frequency not known (frequency cannot be estimated from the available data):skin stretch marks, perioral dermatitis, skin discoloration, skin hypersensitivity reactions, excessive hair growth, blurred vision.
During local use of corticosteroid products, systemic effects may occur due to their absorption through the skin.
If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE ADVANTAN CREAM

Store at a temperature below 25°C.
Store 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Advantan cream contains

• The active substance of the medicine is methylprednisolone aceponate. 1 g of cream contains 1 mg of methylprednisolone aceponate.
• The medicine also contains: decyl oleate, glycerol monostearate, cetyl alcohol, solid fat (Witepsol W 35), triglyceride mixture of fatty acids (Softisan 378), macrogol stearate, glycerol 85%, disodium edetate, benzyl alcohol, butylhydroxytoluene, purified water.

What Advantan cream looks like and what the pack contains

White to yellowish opaque cream.
Packaging:
Aluminum tubes containing 15 g, 25 g, 30 g, or 50 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20090 Segrate (Milan)
Italy
To obtain more detailed information, the doctor or the marketing authorization holder should be contacted:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40

Date of the last update of the leaflet: