Advantan

PATIENT LEAFLET: INFORMATION FOR THE USER

Advantan,1 mg/g, skin emulsion
(Methylprednisolone aceponate)

Table of contents of the leaflet

• 1. What is Advantan skin emulsion and what is it used for
• 2. Important information before using Advantan skin emulsion
• 3. How to use Advantan skin emulsion
• 4. Possible side effects
• 5. How to store Advantan skin emulsion
• 6. Contents of the pack and other information

1. WHAT IS ADVANTAN SKIN EMULSION AND WHAT IS IT USED FOR

Advantan skin emulsion 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, leading to the relief 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 SKIN EMULSION

When not to use Advantan skin emulsion:

• when treated areas have
• bacterial skin infections (e.g. tuberculosis or syphilis) 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 used.
Local use of the medicine may exacerbate local skin infections.
Eye contact, open wounds, and mucous membranes should be avoided.
When using the medicine on the face, caution should be exercised and occlusive dressing should not be used. Using the medicine on the face can lead to skin atrophy more often than when used on other parts 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 skin emulsion. Similarly, as with systemic corticosteroids, during treatment with Advantan skin emulsion, there is a risk of developing glaucoma (e.g. when using large doses of the medicine or using the medicine on large skin areas or for a long time, as well as after applying the medicine under occlusive dressing or on the skin close to the eyes).
Using the medicine on large skin areas should be as short as possible.
Using the medicine on damaged skin, in skin folds, on large skin areas, 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 play the role of occlusive dressing. 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 dressing (sealing, e.g. diapers) should not be used.

Advantan and other medicines

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

Driving and using machines

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

3. HOW TO USE ADVANTAN SKIN EMULSION

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Advantan skin emulsion 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 skin emulsion is too strong or too weak, the doctor should be consulted.

Using a higher dose of Advantan skin emulsion than recommended

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

Missing a dose of Advantan skin emulsion

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 skin emulsion

In case of recurrence of the initial symptoms of the disease 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 skin emulsion can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The most common side effects observed during clinical trials were burning and itching at the application site.
During treatment with Advantan skin emulsion, the following side effects may occur:
Common (affecting 1 to 10 people in 100):burning at the application site, itching at the application site.
Uncommon (affecting 1 to 10 people in 1,000):skin thinning (atrophy), bruising, eczema, oily skin, blisters at the application site, dryness at the application site, redness at the application site, irritation at the application site, eczema and papules at the application site, peripheral edema.
Frequency not known (frequency cannot be estimated from the available data):hypersensitivity reactions to the medicine, excessive hair growth, acne, superficial blood vessel dilatation (telangiectasia), skin striae, perioral dermatitis, skin discoloration, folliculitis at the application site, skin hypersensitivity reactions, blurred vision.
During local use of products containing corticosteroids, systemic effects may occur due to their absorption through the skin.
If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 SKIN EMULSION

Store below 25°C.
Keep out of the 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 no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Advantan skin emulsion contains

• The active substance of the medicine is methylprednisolone aceponate. 1 g of skin emulsion contains 1 mg of methylprednisolone aceponate.
• The medicine also contains: white wax, liquid paraffin, white petrolatum, Dehymuls E, purified water.

What Advantan skin emulsion looks like and what the pack contains

Skin emulsion, white to yellowish, opaque.
Packaging:
Aluminum tubes containing 15 g, 25 g, or 50 g of skin emulsion, 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
tel: 22 244 18 40

Date of last revision of the leaflet: