Advantan

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Advantan (Адвантан), 1 mg/g (0.1%), ointment
Methylprednisolone aceponate
Advantan and Адвантан are the same brand names of the same medicine written in the Polish and Bulgarian languages.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Advantan ointment is and what it is used for
2. What you need to know 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 ADVANTAN OINTMENT IS AND WHAT IT IS USED FOR

Advantan ointment contains the active substance methylprednisolone aceponate, which is a potent glucocorticoid for topical use. After topical application to the skin, methylprednisolone aceponate exerts anti-inflammatory, antipruritic, and vasoconstrictive effects, leading to the relief of symptoms such as redness, swelling, exudation, itching, burning, and pain.
Indications
Eczema (atopic dermatitis, neurodermatitis), contact dermatitis, miliaria (heat rash), non-allergic eczema, eczema in children.

2. IMPORTANT INFORMATION BEFORE USING ADVANTAN CREAM

When not to use Advantan cream:

• if the patient has a known allergy (hypersensitivity) to the active substance or to any of the other ingredients of Advantan
• when the areas being treated include:
  • skin infections caused by bacteria (e.g. tuberculous or syphilitic lesions) or fungi
  • lesions associated with viral diseases (e.g. shingles, chickenpox)
  • 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
Advantan 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 worsen existing local skin infections.
Avoid contact of the medicine with eyes, open wounds, and mucous membranes.
When applying the medicine to the facial skin, caution is advised and occlusive dressings should not be used. Application to the face may lead more frequently than on other body areas to skin atrophy.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If the patient has a history of glaucoma, this should be reported to the physician before using Advantan cream. As with other corticosteroids with systemic effects, treatment with Advantan cream may carry a risk of developing glaucoma (e.g. when high doses are used, large skin areas are treated, prolonged treatment is required, or when the medicine is applied under occlusive dressing or near the eyes).
Treatment over large skin areas should be as short as possible.
Application to damaged skin, skin folds, large skin areas, prolonged use, or use under occlusive dressing significantly increases the risk of systemic adverse effects typical of corticosteroids.
Occlusive dressings (sealed dressings) should be avoided. In children, diapers may act as occlusive dressings. Conditions similar to those under 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, Advantan should be used cautiously—using the smallest possible doses for the shortest possible duration. Occlusive dressings (sealed dressings, e.g. diapers) should not be used.
Interaction of Advantan with other medicines
There are no reported interactions between Advantan cream and other medicines.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to 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 doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
A doctor may recommend using Advantan in pregnant or breastfeeding women only after careful assessment of the benefit-risk ratio.
Breastfeeding women should not apply Advantan cream to the skin of the breasts.
Avoid using the medicine over large skin areas, for prolonged periods, or under occlusive dressings.
Driving and operating machinery
Advantan has no effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE ADVANTAN CREAM

This medicine should always be used as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
Advantan cream is intended for topical use on the skin only.
Usually, the cream 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 cream is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Advantan cream
There is no risk of acute poisoning after a single overdose applied to the skin (application over a large skin surface under conditions of enhanced absorption) or after accidental ingestion of the medicine.
Missed dose of Advantan cream
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 a missed dose.
Discontinuation of Advantan cream
If the original symptoms recur after completion of treatment, contact 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 ointment can cause adverse reactions, although not everybody will experience them.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in the leaflet occur, inform your doctor or pharmacist.
The most commonly observed adverse reactions during clinical trials were:
folliculitis at the application site and burning sensation at the application site.
Common (occurs in 1 to 10 people out of 100): folliculitis at the application site, burning sensation at the application site.
Uncommon (occurs in 1 to 10 people out of 1,000): pustules at the application site, vesicles at the application site, itching at the application site, pain at the application site, erythema at the application site, nodules at the application site, skin fissures, superficial blood vessel dilation (telangiectasia).
Frequency not known (frequency cannot be estimated from available data): hypersensitivity reactions to the medicine, excessive hair growth (hypertrichosis), acne, skin atrophy (thinning), striae (stretch marks), perioral dermatitis, skin discoloration, skin hypersensitivity reactions, blurred vision.

When topical corticosteroid products are used, systemic effects may occur as a result of absorption through the skin.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE ADVANTAN CREAM

Store below 25°C.
Keep in a place inaccessible and out of sight 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Advantan ointment contains

• The active substance is methylprednisolone aceponate. Each 1 g of ointment contains 1 mg of methylprednisolone aceponate.
• Other ingredients: white vaseline, light liquid paraffin, white wax, Dehymuls E, purified water.

What Advantan ointment looks like and contents of the pack
A white to slightly yellowish, transparent ointment.
Pack:
An aluminium tube with a screw cap made of plastic, containing 15 g or 30 g of ointment, placed in a cardboard box.
For further information, contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, 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, 20054 Segrate (Milan), Italy
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Bulgaria, the country of export: 20010603
Parallel Import Authorisation number: 81/26