Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
FUSIDIC ACID, BETAMETHASONE VALERATE
Generics (UK) Limited
D07CC01
FUSIDIC ACID, BETAMETHASONE VALERATE
20 + 1 mg/g
Cream
External use
Tubes of 5 gram, 15 gram, 30 gram and 60 grams
Product subject to prescription which may not be renewed (A)
Kymos Pharma Services SL, C/Baldiri Reixac, McDermott Laboratories Ltd. T/A Gerard Laboratories, Mylan Hungary Kft
Corticosteroids, potent, combination with antibiotic
Corticosteroids, potent, combinations with antibiotics
It is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema (children of 1 year and over), discoid eczema, stasis eczema, contact eczema and seborrhoeic eczemawhen secondary bacterial infection is confirmed or suspected
Authorised
2015-06-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ECZIBET 20 MG/G + 1 MG/G CREAM (FUSIDIC ACID AND 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. See section 4. In this leaflet Eczibet 20 mg/g + 1 mg/g cream will be called Eczibet. WHAT IS IN THIS LEAFLET: 1. What Eczibet is and what it is used for 2. What you need to know before you use Eczibet 3. How to use Eczibet 4. Possible side effects 5. How to store Eczibet 6. Contents of the pack and other information 1. WHAT ECZIBET IS AND WHAT IT IS USED FOR Eczibet contains two different types of medicine. One medicine is called fusidic acid. It is a type of antibiotic. The other medicine is called betamethasone. It is a type of corticosteroid (steroid). These two medicines work at the same time in different ways. Eczibet works by: The antibiotic killing germs (bacteria) that cause infections. The corticosteroid reducing any swelling, redness or itchiness of your skin. Eczibet is used to treat: Conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria). If there is no improvement after 7 days you should stop using the cream and go back to your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ECZIBET DO NOT USE ECZIBET If you are allergic to fusidic acid or betamethasone or any of the other ingredients in this medicine (listed in Section 6). To treat infected dermatitis in infants under one year of age. To treat acne vulgaris. To treat a skin condition called acne rosacea. This is redness and inflammation over Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eczibet 20 mg/g + 1 mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream contains 20 mg fusidic acid and 1 mg betamethasone corresponding to 1,214 mg betamethasone valerate. Excipients with known effect: Contains cetostearyl alcohol 72 mg/g and chlorocresol 1 mg/g. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White to off white, smooth, homogeneous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eczibet 20 mg/g + 1 mg/g cream is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema (children of 1 year and over), discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A single treatment course should not normally exceed 2 weeks. Method of administration For cutaneous use A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. In the more resistant lesions the effect of fusidic acid/betamethasone cream can be enhanced by occlusion with polyethylene film. Overnight occlusion is usually adequate. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, fusidic acid/betamethasone cream is contraindicated in the following conditions: Infants under one year of age with infected dermatitis. 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 or syphilis, either untreated or uncontrolled by appropriate therapy. Acne vulgaris. Perioral dermatitis and rosacea. 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 ___ ___ ___ _ Przeczytaj cały dokument