Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Betamethasone dipropionate; Salicylic acid
Organon Pharma (Ireland) Limited
D07XC; D07XC01
Betamethasone dipropionate; Salicylic acid
0.05 %w/w+2 percent weight/weight
Cutaneous solution
Corticosteroids, potent, other combinations; betamethasone
Marketed
1983-10-27
PACKAGE LEAFLET: INFORMATION FOR THE USER DIPROSALIC® 0.05% W/W + 2% W/W SCALP APPLICATION Betamethasone (as dipropionate)/Salicylic acid _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Diprosalic Scalp Application is and what it is used for 2. Before you use Diprosalic Scalp Application 3. How to use Diprosalic Scalp Application 4. Possible side effects 5. How to store Diprosalic Scalp Application 6. Further information 1. WHAT DIPROSALIC SCALP APPLICATION IS AND WHAT IT IS USED FOR Diprosalic Scalp Application 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 Scalp Application is used to treat skin conditions where the outer surface of the skin is covered by a layer of scales. Your scalp application will remove the layer of scales and reduce the redness and itchiness caused by your skin problem. 2. BEFORE YOU USE DIPROSALIC SCALP APPLICATION DO NOT USE DIPROSALIC SCALP APPLICATION - if you are allergic (hypersensitive) to betamethasone dipropionate, salicylic acid or any of the other ingredients in Diprosalic Scalp Application. - on a Läs hela dokumentet
Health Products Regulatory Authority 30 July 2021 CRN00C803 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DiproSalic 0.05% w/w + 2% w/w Scalp Application 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 0.05 % w/w Betamethasone (as dipropionate) 2.00 % w/w Salicylic Acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A colourless, translucent viscous cutaneous solution. 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: In most cases a few drops should be applied to the affected areas once or twice daily and massaged gently and thoroughly into the skin. 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. Health Products Regulatory Authority 30 July 2021 CRN00C803 Page 2 of 5 4.4 SPECIAL WA Läs hela dokumentet