Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clobetasone butyrate
GlaxoSmithKline UK Ltd
D07AB01
Clobetasone butyrate
500microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5000123104307 5000123103126
PACKAGE LEAFLET: INFORMATION FOR THE USER EUMOVATE OINTMENT 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 to your doctor or pharmacist before using Eumovate. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Eumovate if: you have previ Citiți documentul complet
OBJECT 1 EUMOVATE OINTMENT Summary of Product Characteristics Updated 10-Aug-2017 | GlaxoSmithKline UK 1. Name of the medicinal product Eumovate Ointment 2. Qualitative and quantitative composition 0.05% w/w clobetasone butyrate. 3. Pharmaceutical form Paraffin based ointment. 4. Clinical particulars 4.1 Therapeutic indications Eumovate ointment 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 ADULTS, ELDERLY, CHILDREN AND INFANTS Ointments are especially appropriate for dry, lichenified or scaly lesions. 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 clobetasone to ensure the amount applied is the minimu Citiți documentul complet