Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Fusidic acid; Betamethasone
Leo Laboratories Limited
D07CC; D07CC01
Fusidic acid; Betamethasone
20 + 1 milligram(s)/gram
Cream
Product subject to prescription which may not be renewed (A)
Corticosteroids, potent, combinations with antibiotics; betamethasone and antibiotics
Marketed
2006-05-12
PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIBET ® LIPID 20 MG/G + 1 MG/G CREAM Fusidic acid/betamethasone 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. In this leaflet Fucibet ® lipid cream will be called Fucibet ® . WHAT IS IN THIS LEAFLET: 1. WHAT FUCIBET ® IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIBET ® 3. HOW TO USE FUCIBET ® 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FUCIBET ® 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FUCIBET® IS AND WHAT IT IS USED FOR Fucibet ® contains two different types of medicine. One medicine is called fusidic acid. It is a type of antibiotic. The other medicine is called betamethasone valerate. It is a type of corticosteroid (steroid). The two medicines work at the same time in different ways. Fucibet ® works by: • The antibiotic killing germs (bacteria) that cause infections. • The corticosteroid reducing any swelling, redness or itchiness of your skin. Fucibet ® is used to treat: • Conditions where the skin is inflamed (eczema or dermatitis) and infected, or might become infected, by germs (bacteria). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIBET® DO NOT USE FUCIBET ® If you are allergic (hypersensitive) to fusidic acid/sodium fusidate or betamethasone valerate or any of the other ingredients of this medicine (listed in section 6). To treat a skin infection caused by a fungus, such as athlete’s foot or ringworm. To treat a skin condition caused by a virus, such as cold sores or chicken pox. To treat skin condi Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucibet Lipid 20mg/g + 1mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone valerate) Excipients with known effect: contains cetostearyl alcohol 40 mg/g, methyl parahydroxybenzoate (E218) 1 mg/g, propyl parahydroxybenzoate (E216) 0.2 mg/g and potassium sorbate 2.5 mg/g. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A white highly viscous oil-in-water emulsion cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Use in inflammatory dermatoses where bacterial infection is present or likely to occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a small quantity to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. 4.3 CONTRAINDICATIONS Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucibet ® Lipid is contraindicated in the following conditions: Systemic fungal infections Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4). Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term continuous topical therapy with Fucibet ® Lipid should be avoided, Depending on application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucibet ® Lipid. Due to the content of corticosteroid, Fucibet ® Lipid should be used with care near the eyes. Avoid getting Fucibet ® H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Přečtěte si celý dokument