Advantan

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

Table of contents of the leaflet

• 1. What is Advantan ointment and what is it used for
• 2. Important information before using Advantan ointment
• 3. How to use Advantan ointment
• 4. Possible side effects
• 5. How to store Advantan ointment
• 6. Package contents and other information

1. WHAT IS ADVANTAN OINTMENT AND WHAT IS IT USED FOR

Advantan ointment contains the active substance methylprednisolone aceponate, which is a glucocorticoid with strong effects, for topical use. After topical 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 OINTMENT

When not to use Advantan ointment:

• 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)
• 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.
Contact of the medicine with the eyes, open wounds, and mucous membranes should be avoided.
When using the medicine on the facial skin, caution should be exercised and occlusive dressings should not be used. Using the medicine on the facial skin 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 ointment. Similarly, as with the use of systemic corticosteroids, there is a risk of developing glaucoma during treatment with Advantan ointment (e.g., when using large doses of the medicine or using it on large areas of skin or for a long time, as well as after applying the medicine under an occlusive dressing or on the skin close to the eyes).
Using the medicine on large areas of skin should be for the shortest possible time.
Using the medicine on damaged skin, in skin folds, on large areas of skin, for a long time, or under an occlusive dressing significantly increases the risk of systemic side effects characteristic of corticosteroids.
Occlusive dressings should be avoided. In children, diapers can act as occlusive dressings. Conditions similar to those after using 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 dressings should not be used (e.g., diapers).

Advantan and other medicines

There are no reports of interactions between Advantan ointment and other medicines.
The doctor or pharmacist should be informed about all medicines used by the patient currently or recently, 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 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.
Breastfeeding women should not use Advantan ointment on the breast skin.
The medicine should be avoided on large areas of skin, for a long time, or under an occlusive dressing.

Driving and using machines

Advantan does not affect the ability to drive and use machines.

3. HOW TO USE ADVANTAN OINTMENT

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Advantan ointment is intended for topical 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 the effect of Advantan ointment is too strong or too weak, the doctor should be consulted.

Using a higher dose of Advantan ointment 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 under conditions of increased absorption) or after accidental ingestion of the medicine.

Missing a dose of Advantan ointment

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

Stopping the use of Advantan ointment

In case of recurrence of the primary 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 ointment can cause side effects, although they may not occur in everyone.
If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor or pharmacist should be informed.
The most commonly observed side effects during clinical trials were folliculitis at the application site and burning at the application site.
Common (occurs in 1 to 10 people out of 100):folliculitis at the application site, burning at the application site.
Uncommon (occurs in 1 to 10 people out of 1,000):pustules at the application site, blisters at the application site, itching at the application site, pain at the application site, redness at the application site, nodules at the application site, skin cracks, superficial vessel dilatation (telangiectasia).
Frequency not known (frequency cannot be estimated from available data):hypersensitivity reactions to the medicine, hypertrichosis, acne, skin thinning (atrophy), skin striae, perioral dermatitis, skin discoloration, skin hypersensitivity reactions, blurred vision.
During topical use of products containing corticosteroids, systemic symptoms may occur due to their absorption through the skin.
If any side effects occur, including those not mentioned in the leaflet, the doctor or pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 gather more information on the safety of the medicine.

5. HOW TO STORE ADVANTAN OINTMENT

Store at a temperature below 30°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging.
The expiration date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Advantan ointment contains

• The active substance of the medicine is methylprednisolone aceponate. 1 g of ointment contains 1 mg of methylprednisolone aceponate.
• The medicine also contains: white petrolatum, liquid paraffin, microcrystalline wax, hydrogenated castor oil.

What Advantan ointment looks like and what the package contains

White to yellowish transparent ointment.
Packaging:
Aluminum tubes containing 15 g, 25 g, 30 g, or 50 g of ointment, 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 marketing authorization holder should be contacted:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: 22 244 18 40

Date of the last update of the leaflet: