Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CLOBETASONE BUTYRATE
GlaxoSmithKline (Ireland) Limited
D07AB; D07AB01
CLOBETASONE BUTYRATE
0.05 percent weight/weight
Ointment
Product subject to prescription which may be renewed (B)
Corticosteroids, moderately potent (group II); clobetasone
Not marketed
1976-06-03
Reason for Update: Type Iain Project Pine CMC update (PZN address is grey shaded therefore no live artwork impacted thus no change to date in PIL) Market: Ireland Agency Approval Date: 30/06/2022 Text Date: 10/06/2022 Text Issue and Draft No.: Issue 9 draft 1 PACKAGE LEAFLET: INFORMATION FOR THE USER EUMOVATE OINTMENT 0.05% W/W 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. In this leaflet, Eumovate Ointment 0.05% w/w will be called Eumovate. 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 which belongs to a group of medicines called corticosteroids. It helps to reduce redness, swelling and irritation of the skin. (These should not be confused with “anabolic” steroids misused by some body builders and athletes and taken as tablets or injections). Eumovate relieves the symptoms of certain skin problems including: - eczema including seborrhoeic eczema (red skin with greasy looking white or yellowish-coloured scales) and a type of skin reaction triggered by exposure to sunlight (photodermatitis) - skin rash due to allergy or a substance that irritates your skin (irritant or allergic contact dermatitis) - dermatitis - inflammation of the outer ear (otitis externa) - itchy nodules on the arms or legs (prurigo nodulari Les hele dokumentet
Health Products Regulatory Authority 09 March 2021 CRN009Z2W Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eumovate Ointment 0.05% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 0.5 mg clobetasone butyrate (equivalent to 0.05% w/w). This product contains paraffin, see section 4.4. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A smooth white to off-white translucent 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 - Photodermatitis - Otitis externa - Prurigo nodularis - Insect bite reactions Clobetasone may be used as maintenance therapy between courses of one of the more potent topical steroids. Continuous daily treatment for longer than 4 weeks in adults is not recommended (see section 4.2). Extreme caution should be used in the treatment of dermatoses in children under 12 years of age and should not normally exceed 7 days (see section 4.2). Patients should be closely monitored for side effects. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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. Continuous daily treatment for longer than 4 weeks is not recommended. If the condition worsens or does not improve within 4 weeks, treatment and diagnosis should be re-evaluated. Therapy with topical corticosteroids sh Les hele dokumentet