Ország: Málta
Nyelv: angol
Forrás: Malta Medicines Authority
METHYLPREDNISOLONE ACEPONATE
Bayer S.p.a.
D07AC14
METHYLPREDNISOLONE ACEPONATE
OINTMENT
METHYLPREDNISOLONE ACEPONATE 1 milligram(s)/gram
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2007-02-13
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ADVANTAN 0.1% OINTMENT METHYLPREDNISOLONE ACEPONATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Advantan is and what it is used for 2. What you need to know before you use Advantan 3. How to use Advantan 4. Possible side effects 5. How to store Advantan 6. Contents of the pack and other information 1. WHAT ADVANTAN IS AND WHAT IT IS USED FOR Advantan contains methylprednisolone aceponate, a potent corticosteroid. Advantan is used for the treatment of eczema (non contagious, inflammatory dermatitis, that affect the skin surface) such as: constitutional eczema (atopical dermatitis, neurodermatitis), eczema vulgaris, allergic and irritative contact dermatitis, dyshidrotic eczema, eczema in children The formulation of Advantan ointment assures an appropriate amount of lipids to the skin without blocking transpiration and exchanges of heat. Given its characteristics, Advantan ointment has a broad field of application, from skin conditions that are not excessively secreting to those that are not particularly dry. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADVANTAN _ _ DO NOT USE ADVANTAN - if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). - if the area to be treated is affected by tuberculosis or syphilis; - if the subject has viral infections (e.g. chicken pox or shingles); - if the subject has skin conditions accompanied by bacterial or fungal infections; - i Olvassa el a teljes dokumentumot
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Advantan 0.1% cream Advantan 0.1% ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Advantan 0.1% cream 1 g of cream contains: methylprednisolone aceponate 1 mg (0.1%). Excipients with known effects: cetostearylic alcohol and butylhydroxytoluene. Advantan 0.1% ointment 1 g of ointment contains: methylprednisolone aceponate 1 mg (0.1%). For the complete list of excipients, see paragraph 6.1. 3. PHARMACEUTICAL FORM Cream (oil in water emulsion, opaque white to yellowish coloured cream). Ointment (water in oil emulsion, opaque white to yellowish coloured ointment). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Advantan cream and ointment Constitutional eczema (atopical dermatitis, neurodermatitis); eczema vulgaris; allergic and irritative contact dermatitis; dyshidrotic eczema; eczema in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise prescribed by a doctor, Advantan, in the form best suited to the skin characteristics, must be applied topically to the affected area of skin in a thin layer, with gentle massage, once a day. Advantan cutaneous solution must be applied drop by drop, always once a day, on the areas of skin affected by the disorder, and gently massaged in. Page 2 of 12 Advantan is available in four pharmaceutical forms: cream, ointment, fatty ointment and cutaneous solution. Given its high water content, the formulation of Advantan cream (1 g of Advantan cream contains 1 mg of methylprednisolone aceponate) allows exudates to flow, and is therefore particularly suitable for treatment of secreting forms of eczema in the acute phase in areas of skin subject to maceration, exposed and covered with body hair. If application of Advantan cream for prolonged periods of time should induce excessive skin dryness, a formulation with a higher fat content (Advantan ointment or fatty ointment) must be used instead. The formulation of Advantan ointment (1 g of Advantan ointment contains 1 mg of methylprednisolo Olvassa el a teljes dokumentumot