Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
CLOBETASONE BUTYRATE
Glaxo Wellcome UK Limited
D07AB01
CLOBETASONE BUTYRATE
CREAM
CLOBETASONE BUTYRATE 0.05 % (W/W)
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2005-09-12
Reason for Update : Article 46 & QRD version 10 Market: UK Agency Approval Date: 05/10/2016 Text Date: 20/09/2016 Text Issue and Draft No.: Issue 4, draft 3 PACKAGE LEAFLET: INFORMATION FOR THE USER EUMOVATE ® CREAM CLOBETASONE BUTYRATE 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 Eumovate is and what it is used for 2 What you need to know before you use Eumovate 3 How to use Eumovate 4 Possible side effects 5 How to store Eumovate 6 Contents of the pack and other information 1. WHAT EUMOVATE IS AND WHAT IT IS USED FOR Eumovate contains a medicine called clobetasone butyrate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Eumovate is used to: help reduce the redness and itchiness of certain skin problems. It is used for mild skin problems or to keep your skin problem under control. These skin problems include eczema, dermatitis, nappy rash or insect bites. help reduce inflammation of the outer ear. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EUMOVATE DO NOT USE EUMOVATE: if you are allergic to clobetasone butyrate or any of the other ingredients of this medicine (listed in section 6) to treat any of the following skin problems, it could make them worse: - infected skin (unless the infection is being treated with an anti-infective medicine at the same time) - acne - severe flushing of skin on and around your nose (rosacea) - itchy skin which is not inflamed Do not use if any of the above apply to you. If you are not sure, talk Belgenin tamamını okuyun
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eumovate Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 0.05% w/w clobetasone butyrate. Excipients with known effect: Cetostearyl alcohol Chlorocresol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Water miscible cream. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eumovate cream is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: - Atopic dermatitis - Irritant or allergic contact dermatitis - Seborrhoeic dermatitis - Nappy rash - Photodermatitis - Otitis externa - Prurigo nodularis - Insect bite reactions Eumovate may be used as maintenance therapy between courses of one of the more potent topical steroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: CUTANEOUS Page 2 of 9 ADULTS, ELDERLY, CHILDREN AND INFANTS Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations. DURATION OF TREATMENT FOR ADULTS AND ELDERLY Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated. PAEDIATRIC POPULATION Use in children under 12 years should be on the advice of a doctor. Care should be taken when using clobetas Belgenin tamamını okuyun