Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Methylprednisolone aceponate
Bayer Limited
D07AC14
Methylprednisolone aceponate
0.1%w/w percent weight/weight
Ointment
Product subject to prescription which may be renewed (B)
methylprednisolone aceponate
Not marketed
1998-04-03
15660 Package leaflet: Information for the patient ADVANTAN Cream 0.1% w/w ADVANTAN Ointment 0.1% w/w ADVANTAN Fatty Ointment 0.1% w/w Methylprednisolone aceponate (MPA) 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. 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 is an anti-inflammatory medicine (a corticosteroid) which is intended to be used on the skin. Advantan reduces the inflammation and allergic reaction of the skin. Therefore it lessens redness (erythema), fluid build-up (oedema) and fluid oozing from the inflamed skin. It also relieves the itchiness, burning sensation or pain you may feel. Advantan is used for the treatment of skin conditions which are sensitive to corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADVANTAN DO NOT USE ADVANTAN • if you are allergic (hypersensitive) to the active substance methylprednisolone aceponate (MPA) or to any of the other ingredients of Advantan (see also section 6. Contents of the pack and other information) • if pre-existing eczema or rash has become infected 15660 on skin areas affected by a skin inflammation that is red/rosy in colour (rosacea), ulcers, inflamed diseases of the sebaceous glands (acne vulgaris) or skin folds, groin or under the arm pits (intertrigo acne), or skin diseases accompanied by a thinning of the Soma hati kamili
Health Products Regulatory Authority 16 April 2019 CRN008LLS Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Advantan 0.1% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1g Advantan ointment contains 1 mg (0.1%) methylprednisolone aceponate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Water in oil emulsion, white to yellowish opaque ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of corticosteroid sensitive dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In general, the Advantan formulation appropriate to the skin condition is applied thinly once per day to the diseased areas of skin. In general, the duration of use should not exceed 12 weeks in adults. If the skin dries out excessively under protracted use of Advantan Cream, a switch should be made to one of the formulations with a higher fat content (Advantan Ointment or Advantan Fatty Ointment). PEDIATRIC POPULATION Dose adjustments are not required when Advantan ointment and Advantan fatty ointment are administered to infants, children, and adolescents. In general, the duration of use should not exceed 4 weeks in children. The safety of Advantan Cream in infants below the age of 4 months has not been established. 4.3 CONTRAINDICATIONS Known hypersensitivity to the active ingredients or any of its excipients Primary bacterial, viral and fungal diseases of the skin and secondarily infected eczemas or intertrigo acne, perioral dermatitis, rosacea atrophic skin diseases and vaccination skin reactions in the area to be treated and, in general, should not be used on weeping surfaces. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Glucocorticoids must only be used at as low a dose as possible, especially in children, and only for as long as is absolutely necessary to achieve and maintain the desired therapeutic effect. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection r Soma hati kamili