Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
FUSIDIC ACID
LEO Laboratories Limited 285 Cashel Road, Dublin 12, Ireland
D06AX01
FUSIDIC ACID 20 mg
CREAM
FUSIDIC ACID 20 mg
POM
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
Authorised
2005-08-01
PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIDIN ® 20 MG/G CREAM fusidic acid 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. WHAT IS IN THIS LEAFLET 1. WHAT FUCIDIN ® CREAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN ® CREAM 3. HOW TO USE FUCIDIN ® CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FUCIDIN ® CREAM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FUCIDIN ® CREAM IS AND WHAT IT IS USED FOR Fucidin cream belongs to a group of medicines called antibiotics. The antibiotic in this product is called fusidic acid. Fucidin cream works by killing germs (bacteria) that cause infections. It is used to treat skin infections such as those caused by bacteria called _Staphylococcus aureus._ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN ® CREAM DO NOT USE FUCIDIN CREAM: • If you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING FUCIDIN CREAM • Do not use Fucidin cream for a long time as the germs (bacteria) may no longer be killed by the antibiotic. • Avoid getting the cream in your eyes (e.g., accidentally from your hands or by using it too close to your eyes) as it could irritate (sting) them. OTHER MEDICINES AND FUCIDIN CREAM Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT Fucidin 20 mg/g Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 20 mg fusidic acid. Excipients with known effect: Contains butylhydroxyanisole (E320) 0.04 mg/g, potassium sorbate 2.7 mg/g and cetyl alcohol 111 mg/g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. A white cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical treatment of infections due to micro-organisms sensitive to this anti-infective, in particular _Staphylococcus aureus_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Apply three to four times daily or as required. Less frequent application may be adequate for covered lesions. Method of administration Cutaneous use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bacterial resistance among _Staphylococcus aureus _ has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Fucidin cream contains butylhydroxyanisole, potassium sorbate and cetyl alcohol. These excipients may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes. Fucidin cream should therefore be used with care when applied in the proximity of the eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin is negligible. 4.6 FERTILITY, PREGNANCY AND LACTATION Fertility There are no clinical studies with topical Fucidin regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically-applied fusidic acid/sodium fusidate is negligible. Pregnancy No e Baca dokumen lengkap