국가: 몰타
언어: 영어
출처: Medicines Authority
FUSIDIC ACID, HYDROCORTISONE ACETATE
LEO Laboratories Limited 285 Cashel Road, Dublin 12, Ireland
D07CA01
FUSIDIC ACID 20 mg/g HYDROCORTISONE ACETATE 10 mg/g
CREAM
FUSIDIC ACID 20 mg/g HYDROCORTISONE ACETATE 10 mg/g
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2005-08-01
BATCH RELEASE SITE ITALY PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIDIN ® H 20 MG/G + 10 MG/G CREAM Fusidic acid/hydrocortisone acetate 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. WHAT IS IN THIS LEAFLET 1. WHAT FUCIDIN ® H CREAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN ® H CREAM 3. HOW TO USE FUCIDIN ® H CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FUCIDIN ® H CREAM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FUCIDIN® H CREAM IS AND WHAT IT IS USED FOR Fucidin ® H cream contains two different types of medicine. One medicine is called fusidic acid. It is a type of antibiotic. The other medicine is called hydrocortisone acetate. It is a type of corticosteroid (steroid). The two medicines work at the same time in different ways. Fucidin ® H cream works by: The antibiotic killing germs (bacteria) that causes infections. The corticosteroid reducing any swelling, redness or itchiness of your skin. It 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 FUCIDIN® H CREAM DO NOT USE FUCIDIN ® H CREAM: If you are allergic (hypersensitive) to fusidic acid/sodium fusidate or hydrocortisone acetate or any other ingredients of this medicine (listed in section 6). AS THIS MEDICINE CONTAINS A STEROID DO NOT USE • To treat skin conditions caused by a fungus, such as athlete’s foot or ringworm • To treat skin conditions caused by a virus, such as cold sor 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fucidin ® H 20 mg/g + 10 mg/g Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains fusidic acid, anhydrous (as hemihydrate) 20 mg and hydrocortisone acetate 10 mg. Excipients with known effect Butylhydroxyanisole (E320) 0.04 mg Cetyl alcohol 111 mg potassium sorbate 2.7 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cream. A white, homogeneous 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, hydrocortisone acetate or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucidin® H is contraindicated in the following conditions: 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 Page 1 of 7 therapy. Perioral dermatitis and rosacea. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term continuous topical therapy with Fucidin® H should be avoided. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with topical steroids. Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin® H. Due to the content of corticosteroid, Fucidin® H should be used with care near the eyes. Avoid getting Fucidin® H into the eyes (see section 4.8). Raised intra-ocular pressure and glaucoma can also be caused by topical use of corticosteroids on the face, particularly with prolonged use near 전체 문서 읽기