ADVANTAN

Advantan, 1 mg/g, skin emulsion
(Methylprednisolone aceponate)
Contents of the package leaflet

1. What Advantan skin emulsion is and what it is 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 ADVANTAN SKIN EMULSION IS AND WHAT IT IS USED FOR

Advantan skin emulsion contains the active substance methylprednisolone aceponate,
which is a potent glucocorticoid intended for topical use. When applied locally to the skin,
methylprednisolone aceponate exerts anti-inflammatory, antipruritic, and vasoconstrictive effects,
alleviating symptoms such as redness, swelling, exudation, itching, burning, and pain.
Indications for use
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (heat rash), non-allergic dermatitis, infantile eczema.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN EMULSION

FOR DERMAL USE
When not to use Advantan emulsion:

• if the patient has hypersensitivity (allergy) to the active substance or to any of the other components of Advantan emulsion
• when the following conditions are present at the sites to be treated:
• skin infections caused by bacteria (e.g. tuberculous or syphilitic lesions) or fungi
• lesions associated with viral diseases (e.g. herpes zoster, varicella)
• rosacea
• acne
• perioral dermatitis
• ulcers
• local reactions following vaccination
• in atrophic skin disorders (atrophy)

Do not use in children under 2 years of age.
Warnings and precautions
The medicine should be used, especially in children, in the smallest possible dose and for the shortest possible duration.
If the physician determines that a bacterial or fungal skin infection is present, additional antibacterial or antifungal treatment should be applied.
Topical use of the medicine may exacerbate local skin infections.
Contact with eyes, open wounds and mucous membranes should be avoided.
When applying the medicine to the facial skin, caution should be exercised and occlusive dressings should not be used. Application to facial skin may lead to skin atrophy more frequently than when applied to other areas of the body.
If blurred vision or other visual disturbances occur, the patient should contact a physician.
If the patient has a history of glaucoma, this should be reported to the physician before using Advantan emulsion. As with systemic corticosteroids, treatment with Advantan emulsion may carry a risk of developing glaucoma (e.g. when high doses are used, when applied over large skin areas or for prolonged periods, as well as when applied under occlusive dressings or near the eyes).
Application over large skin areas should be as short as possible.
Use on damaged skin, in skin folds, over large skin areas, prolonged use, or under occlusive dressings significantly increases the risk of systemic adverse effects typical of corticosteroids.
Occlusive dressings (occluding) should be avoided. In children, diapers may act as occlusive dressings. Conditions similar to those after occlusive dressings may 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 cautiously – in the smallest possible doses and for the shortest possible duration. Occlusive dressings (occluding, e.g. diapers) should not be used.
Interaction of Advantan with other medicines
There are no reports on interactions between Advantan emulsion and other medicines.
The patient should inform the physician or pharmacist about all medicines currently or recently used, as well as any medicines planned for future use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a physician or pharmacist before using this medicine.
The medicine should not be used during the first trimester of pregnancy.
A physician may recommend using the medicine in pregnant women and breastfeeding mothers after carefully assessing the benefit-risk ratio.
Breastfeeding women should not apply Advantan emulsion to the breasts.
The medicine should be avoided on large skin areas, prolonged use, or under occlusive dressings.
Driving and operating machinery
Advantan has no effect on the ability to drive or operate machinery.

3. HOW TO USE ADVANTAN EMULSION FOR THE SKIN

This medicine should always be used exactly as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Advantan emulsion for the skin is intended for topical use only.
Usually, the medicine should be applied in a thin layer to the affected skin once daily.
This medicine 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 emulsion for the skin is too strong or too weak,
consult your doctor.
Use of more than the recommended dose of Advantan emulsion for the skin
There is no risk of acute poisoning after a single overdose of the topical medicine (application over a large
skin surface under conditions of enhanced absorption) or after accidental ingestion of the medicine.
Missed dose of Advantan emulsion for the skin
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 the missed dose.
Stopping treatment with Advantan emulsion for the skin
If the original symptoms return 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 ADVERSE REACTIONS

Like all medicines, Advantan emulsion for skin may cause adverse reactions, although not
everyone will experience them.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur,
you should inform your doctor or pharmacist.
The most commonly observed adverse reactions reported during clinical trials were:
burning sensation and itching at the application site.
When using Advantan emulsion for skin, the following adverse reactions may occur:
Common (occur in 1 to 10 out of 100 people): burning at the application site, itching at the application site.
Uncommon (occur in 1 to 10 out of 1,000 people): skin thinning (atrophy), petechiae,
lichenification, oily skin, vesicles at the application site, dryness of skin at the application site,
erythema at the application site, irritation at the application site, rash and papules at the application site, peripheral oedema.
Frequency unknown (frequency cannot be estimated from available data): hypersensitivity reactions to the medicine, excessive hair growth, acne, dilatation of superficial blood vessels (telangiectasia), striae, perioral dermatitis, skin discoloration, folliculitis at the application site, skin hypersensitivity reactions, blurred vision.
When applying topical corticosteroid products, systemic adverse effects may occur as a result of absorption through the skin.
If any adverse reactions occur, including any not mentioned in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE ADVANTAN EMULSION FOR THE SKIN

Store below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
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 PACKAGE AND OTHER INFORMATION

What Advantan skin emulsion contains

• The active substance is methylprednisolone aceponate. 1 g of skin emulsion contains 1 mg of methylprednisolone aceponate.
• Other ingredients: white wax, liquid paraffin, white soft paraffin, Dehymuls E, purified water.

What Advantan skin emulsion looks like and contents of the pack
Skin emulsion, white to yellowish, opaque.
Pack sizes:
Aluminium tubes containing 15 g, 25 g or 50 g of skin emulsion, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact your doctor or the Marketing Authorisation Holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40