País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate; Fusidic acid
LEO Pharma
D07CC01
Betamethasone valerate; Fusidic acid
1mg/1gram ; 20mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5702191001044 5702191004519
Daivonex ® range - 10 g, 15 g, 30 g, 60 g Daivobet ® range - 10 g, 15 g, 30 g, 60 g Fucidin ® range - 15 g, 30 g, 60 g Fucicort ® range - 15 g, 30 g, 60 g FRONT OF LEAFLET Creation Date: Revision Date: Sign: Sign: Scale: OMA 24/08/2015 OMA 06/07/2018 Ref. No.: Size: Material: Type: 100% IIE042-03 610 x 350 mm Insert PACKAGING COMPONENT SPECIFICATION LEO Pharma Internal Market Access Industriparken 55 2750 Ballerup Denmark 610x350_105x28_mF_154_AK2_Rev 4 Folded to 105 x 28 mm Comments: IIE042-00 - 13/09/2016 - OMA: New leaflet based on trial 99991530 with new supplier drawing IIE042-01 - 06/11/2017 - JUG: Material number Font and size defind and info added on drawing IIE042-02 - 16/05/2018 - OMA: Updated with drawing from Essentra containing new folding pattern IIE042-03 - 06/07/2018 - OMA: Updated with drawing from Essentra containing new folding pattern and i-mark position Revision info: Used for: Only to be used together with CIE093 37 x 32 x 120 mm, CIE094 44 x 32 x 140 mm, CIE095 47 x 38 x 160 mm and LINE 8 TUBE AND PACKRAT CARTON CIE110 + CIE120 + CIE0130 + CIE140 610 mm 350 mm IIE042-03 - 610 x 350 mm - page 1 of 2 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • In this leaflet Fucibet ® cream will be called Fucibet®. PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIBET® CREAM FUSIDIC ACID AND BETAMETHASONE VALERATE 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 Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucibet ® Cream. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fucibet ® Cream contains Fusidic acid Ph.Eur.2% and Betamethasone 0.1% (as the valerate ester Ph.Eur) Excipients with known effect: Cetostearyl alcohol contains 72mg. Chlorocresol contains 1mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream A white cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fucibet cream is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema, discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of Fucibet ® cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate. Method of administration Cutaneous use 4.3 CONTRAINDICATIONS Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucibet 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 or syphilis, 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 should be avoided. Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucibet. Due to the content of corticosteroid, Fucibet should be used with care near the eyes. Avoid getting F Leer el documento completo