Advantan
Poland
Table of Contents
Caution! Keep this leaflet! Information on the immediate packaging in a foreign language
Advantan, 1 mg/g, ointment
Methylprednisoloni aceponas
Please read carefully the information contained in this leaflet 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Advantan ointment is and what it is used for
- Important information before using Advantan ointment
- How to use Advantan ointment
- Possible side effects
- How to store Advantan ointment
- 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 intended 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 erythema, edema, exudation, pruritus, 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 hypersensitivity (allergy) to the active substance or to any of the other ingredients of Advantan cream
- when the areas being treated include:
- bacterial (e.g. tuberculosis or syphilis lesions) or fungal skin infections
- lesions caused by viral diseases (e.g. shingles, chickenpox)
- rosacea
- acne
- perioral dermatitis
- skin ulcers
- local reactions following vaccination
- 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.
Local application of the medicine may exacerbate existing skin infections.
Avoid contact of the medicine with eyes, open wounds, and mucous membranes.
When applying the medicine to facial skin, caution is required and occlusive dressings must not be used. Application to the face may lead more frequently than application to 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, inform the physician before using Advantan cream. As with systemic corticosteroids, treatment with Advantan cream may carry a risk of developing glaucoma (e.g. when high doses are used, when applied over large skin areas or for prolonged periods, or when applied under occlusive dressings 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 dressings significantly increases the risk of systemic adverse effects typical of corticosteroids.
Occlusive (sealed) dressings should be avoided. In children, diapers may have a similar effect to occlusive dressings. Conditions similar to those under occlusive dressings may also occur in body folds (armpits, groin, skin folds, 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 (sealed, e.g. diapers) must not be used.
Advantan cream and other medicines
There are no reported interactions between Advantan cream and other medicines.
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient intends to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use the medicine during the first trimester of pregnancy.
The doctor may recommend using the medicine 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 cream has no effect on the ability to drive vehicles or operate machinery.
3. HOW TO USE ADVANTAN CREAM
This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Advantan cream is intended for topical use on the skin only.
Usually, the medicine should be applied as 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 larger than recommended dose of Advantan cream
There is no risk of acute poisoning following 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, 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 ointment may cause adverse reactions, although not everyone experiences them.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this 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 (affects 1 to 10 people in 100): folliculitis at the application site, burning sensation at the application site.
Uncommon (affects 1 to 10 people in 1,000): pustular rash 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 cracking, 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 corticosteroid-containing products are applied topically, systemic effects may occur as a result of absorption through the skin.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, 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 stated month.
Medicines must 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. 1 g of ointment contains 1 mg of methylprednisolone aceponate.
- Other ingredients: white vaseline, liquid paraffin, white wax, Dehymuls E, purified water.
What Advantan ointment looks like and contents of the pack
A white to yellowish transparent ointment.
Pack: Aluminium tube internally coated with epoxy resin, with a protective membrane and a screw cap made of HDPE, containing 50 g of ointment, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 11639/2019/05
Parallel import authorisation number: 356/22