País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
clobetasone butyrate, Quantity: 0.5 mg/g
GlaxoSmithKline Australia Pty Ltd
Clobetasone butyrate
Cream
Excipient Ingredients: citric acid monohydrate; chlorocresol; purified water; glycerol; cetostearyl alcohol; glyceryl monostearate; sodium citrate dihydrate; PEG-100 stearate; stearic acid; Carnauba Wax; hard paraffin
Topical
30g, 15g, 5g
(S3) Pharmacist Only Medicine
Short-term (up to 7 days) treatment of milder forms of eczema, dermatitis and other steroid responsive skin conditions.
Visual Identification: Smooth white to off-white cream.; Container Type: Tube; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-12-10
1 EUMOVATE CLOBETASONE BUTYRATE 0.05% W/W CREAM CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ _ _ Please read this leaflet carefully before you start using EUMOVATE Cream. This leaflet answers some common questions about EUMOVATE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using EUMOVATE against the benefits they expect it will have for you. Use EUMOVATE as instructed and follow the advice given in this leaflet._ _ _ _ IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EUMOVATE IS USED FOR EUMOVATE is used to treat eczema and dermatitis. It can help you to control patches of dry, red, itchy, flaky or inflamed skin caused by eczema and dermatitis. EUMOVATE contains clobetasone butyrate. Clobetasone butyrate is a topical corticosteroid. It is used to control inflammation on the skin. EUMOVATE works to stop the skin’s over-reaction to the triggers that cause skin flare ups. It suppresses the inflammation that causes eczema or dermatitis. EUMOVATE cream base also has moisturising properties. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN RECOMMENDED FOR YOU. Your doctor or pharmacist may have recommended it for another reason. BEFORE USING EUMOVATE _WHEN YOU MUST NOT USE IT _ DO NOT USE EUMOVATE IF YOU HAVE AN ALLERGY TO: • any medicine containing clobetasone butyrate • any of the ingredients listed at the end of this leaflet. • any other similar medicines such as hydrocortisone. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT USE EUMOVATE ON: • cuts or open wounds • infected skin • inflamed skin near Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION EUMOVATE (CLOBETASONE BUTYRATE) CREAM 1 NAME OF THE MEDICINE Clobetasone butyrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EUMOVATE cream contains 0.05% w/w clobetasone butyrate as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Cream White cream for topical use 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term (up to 7 days) treatment of milder forms of eczema, dermatitis and other steroid responsive skin conditions. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER Apply a thin film and gently rub in, using only enough to cover the affected area twice daily for up to 7 days. If the condition resolves within 7 days, treatment with EUMOVATE cream should be stopped. If the condition does not improve within the first 7 days or becomes worse, the patient should see a doctor. If after 7 days of treatment, improvement is seen but further treatment is required, the patient should see a doctor. After application, the hands should be washed unless they are the site being treated. Patients advised by their doctors to use this cream for prolonged periods should be advised to tell subsequent doctors about this use. All patients should be warned against prolonged used on one area of skin, or use of excessive quantities. 2 All patients should also be informed that the preparation is prescribed only for a specific condition occurring in a specific individual. CHILDREN Use in children under 12 years only on the advice of a doctor. Children are more likely to develop local and systemic adverse reactions of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Care should be taken when using EUMOVATE cream to ensure the amount applied is the minimum that provided therapeutic benefit. ELDERLY Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal fu Leia o documento completo