Страна: Мальта
мова: англійська
Джерело: Medicines Authority
FUSIDATE SODIUM
LEO Pharma A/S
D06AX01
FUSIDATE SODIUM
OINTMENT
FUSIDATE SODIUM 20 mg/g
POM
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
Authorised
2005-08-01
Page 1 of 4 PACKAGE INSERT LEAFLET FUCIDIN® OINTMENT _In this leaflet:_ 1. What Fucidin® ointment is and what it is used for 2. Before you use Fucidin® ointment 3. How to use Fucidin® ointment 4. Possible side effects 5. How to store Fucidin® ointment FUCIDIN® OINTMENT Active substance: Sodium fusidate 20 mg/g Other ingredients: Cetyl alcohol, wool fat, liquid paraffin and white soft paraffin. PRESENTATION AND CONTENTS Tubes containing 15 g of ointment MARKETING AUTHORISATION HOLDER LEO Pharmaceutical Products Industriparken 55, DK-2750 Ballerup, Denmark MANUFACTURER LEO Laboratories Ltd. 285 Cashel Road, IRL-Dublin 12, Ireland 1. WHAT FUCIDIN® OINTMENT IS AND WHAT IT IS USED FOR Fucidin® ointment belongs to a group of medicines called antibiotics. The antibiotic in this product is called sodium fusidate. Fucidin® ointment 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. BEFORE YOU USE FUCIDIN® OINTMENT FUCIDIN® OINTMENT MUST NOT BE USED if you are allergic to sodium fusidate or any of the other ingredients of this medicine. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING FUCIDIN® OINTMENT Do not use Fucidin® for a long time as the germs (bacteria) may no longer be killed by the antibiotic. v 00574133 1.0 Page 2 of 4 Avoid getting the ointment in your eyes (e.g. accidentally from your hands or by using it too close to your eyes) as it could irritate (sting) them. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant or think you might be pregnant; Fucidin® ointment may be used during pregnancy. If you are breast-feeding; Fucidin® ointment may be used by women who are breast-feeding but the ointment should not be applied to the breast. DRIVING AND USING MACHINES This medicine should not Прочитайте повний документ
1. NAME OF THE MEDICINAL PRODUCT Fucidin® Ointment, 20 mg/g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium fusidate 20 mg/g For excipients, see 6.1. 3. PHARMACEUTICAL FORM Ointment. Translucent yellowish to white ointment. 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 Adults and children: Uncovered lesions: apply gently three to four times daily as required. Covered lesions: less frequent applications may be adequate. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special Warning 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® Ointment contains cetyl alcohol and wool fat (lanolin). These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin® Ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. When Fucidin® Ointment is used on the face; care should be taken to avoid contact with the eyes as the sodium salt of fusidic acid may cause conjunctival irritation. 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 Прочитайте повний документ