Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BETAMETHASONE DIPROPIONATE, SALICYLIC ACID
Merck Sharp & Dohme Ireland (Human Health) Limited
D07XC01
BETAMETHASONE DIPROPIONATE, SALICYLIC ACID
3 %w/w
Ointment
Product subject to prescription which may be renewed (B)
Corticosteroids, potent, other combinations
Authorised
2010-11-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIPROSALIC® 0.05% W/W / 3% W/W OINTMENT Betamethasone dipropionate/salicylic acid_ _ 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. WHAT IS IN THIS LEAFLET: 1. What diprosalic ointment is and what it is used for 2. What you need to know before you use diprosalic ointment 3. How to use diprosalic ointment 4. Possible side effects 5. How to store diprosalic ointment 6. Contents of the pack and other information 1. WHAT DIPROSALIC OINTMENT IS AND WHAT IT IS USED FOR Diprosalic ointment contains two active ingredients, betamethasone dipropionate and salicylic acid. Betamethasone dipropionate is one of a group of medicines called topical corticosteroids. It is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. Salicylic acid softens the top layer of scales on the surface of the skin, which are caused by your skin problem. This allows the betamethasone dipropionate to reach the diseased skin underneath to help heal it. In adults and children, diprosalic ointment is used to treat skin conditions where the outer surface of the skin is covered by a layer of scales. Your ointment will remove the layer of Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DiproSalic 0.05% w/w + 3% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Smooth, off-white ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. In combination with salicylic acid it is indicated for the treatment of chronic lichenified eczema, lichen planus, lichen simplex and non bullous ichthyosiform erythroderma. It is also effective in the less responsive conditions such as psoriasis of the scalp and chronic plaque psoriasis of the hands and feet but excluding widespread plaque psoriasis. Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Once to twice daily. In most cases a thin film should be applied to cover the affected area once or twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. It is recommended that DiproSalic preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60g. Children : Dosage in children should be limited to 5 days. 4.3 CONTRAINDICATIONS Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the DiproSalic preparations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vaccinia, varicella. DiproSalic should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy. 0.05 % w/w Betamethasone (as dipropionate) 3.00 % w/w Salicylic Lesen Sie das vollständige Dokument