Advantan

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language

Advantan, 1 mg/g, ointment

Methylprednisolone aceponate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

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. Contents of the pack 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 corticosteroid with strong effects, for topical use. After topical application to the skin, methylprednisolone aceponate has anti-inflammatory, anti-itching, 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:

• if the patient has been diagnosed with hypersensitivity (allergy) to the active substance or any of the other ingredients of Advantan ointment
• when the 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, they will also use antibacterial or antifungal treatment.
Local use of the medicine may exacerbate local skin infections.
Avoid contact of the medicine with the eyes, open wounds, and mucous membranes.
When using the medicine on the skin of the face, be cautious and do not use an occlusive dressing. Using the medicine on the skin of the face may lead to skin atrophy more often than when using it 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, inform the doctor before using Advantan ointment. Similarly, as with systemic corticosteroids, during treatment with Advantan ointment, there is a risk of developing glaucoma (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.
Avoid using an occlusive dressing. In children, diapers can act as an occlusive dressing. Conditions similar to those after using occlusive dressings also occur in intertriginous areas of the body (armpits, groin, skin folds, skin between the fingers).

Children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, use the medicine with caution - in the smallest possible doses for the shortest possible time. Do not use an occlusive dressing.

Advantan ointment and other medicines

There are no reports of interactions between Advantan ointment and other medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
Your 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 ointment on the breast skin.
Avoid using the medicine on large areas of skin, for a long time, or under an occlusive dressing.

Driving and using machines

Advantan ointment does not affect the ability to drive or operate machines.

3. HOW TO USE ADVANTAN OINTMENT

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Advantan ointment is for topical use on the skin only.
Usually, the medicine is applied in a thin layer to the affected skin once a day.
Do not use the medicine 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 you feel that the effect of Advantan ointment is too strong or too weak, consult your doctor.

Using more than the recommended dose of Advantan ointment

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

Missing a dose of Advantan ointment

If you miss a dose of the medicine at the scheduled time, use it as soon as possible.
Do not use a double dose to make up for the missed dose.

Stopping treatment with Advantan ointment

If the patient experiences a recurrence of the original disease symptoms after completing treatment, they should contact their doctor.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Advantan ointment 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 commonly observed side effects during clinical trials were folliculitis at the application site and burning at the application site.
Common (affects 1 to 10 people in 100):folliculitis at the application site, burning at the application site.
Uncommon (affects 1 to 10 people in 1000):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 (cannot be estimated from the available data):hypersensitivity reactions to the medicine, excessive hair growth, acne, skin thinning (atrophy), skin stretch marks, 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.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ADVANTAN OINTMENT

Store in a temperature below 25°C, in the original packaging.
Keep the medicine 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 stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Advantan ointment contains

• The active substance is methylprednisolone aceponate. 1 g of ointment contains 1 mg of methylprednisolone aceponate.
• The other ingredients are white petrolatum, liquid paraffin, white wax, Dehymuls E, purified water.

What Advantan ointment looks like and contents of the pack

White to yellowish transparent ointment.
Packaging: aluminum tube internally coated with epoxy resin, with a protective membrane and an HDPE screw cap, containing 50 g of ointment, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, 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
20090 Segrate (Milan), Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:11639/2019/05

Parallel import authorization number: 356/22 Date of approval of the leaflet: 26.09.2022

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