País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fusidic acid
Mawdsley-Brooks & Company Ltd
D06AX01
Fusidic acid
20mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100102
White space White space FUSIDIC ACID 2% CREAM 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. 1. What Fusidic Acid is and what it is used for 2. What you need to know before you use Fusidic Acid 3. How to use Fusidic Acid 4. Possible side effects 5. How to store Fusidic Acid 6. Contents of the pack and other information WHAT FUSIDIC ACID IS AND WHAT IT IS USED FOR The active substance of Fusidic Acid is fusidic acid. This is an antibiotic (this means that it kills bacteria that cause infections). Fusidic Acid should be used on the skin. The cream is used for the local treatment of skin infections caused by bacteria that are sensitive to fusidic acid (especially staphylococcus infections) such as impetigo (a weeping, crusty and swollen patch of skin), folliculitis (inflammation of one or more hair follicles), sycosis barbae (infection of the bearded skin), paronychia (infection of the tissue surrounding a fingernail or toenail) and erythrasma (infection with brown, scaly skin patches, especially in the folds of the body). It is also used to treat infected dermatitis (inflammation of the skin), spots, cuts and grazes. WHAT YOU NEED TO KNOW BEFORE YOU USE FUSIDIC ACID DO NOT USE FUSIDIC ACID • if you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6). Therefore, always tell your doctor which medicines or other substances you are allergic to. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using FUSIDIC ACID • if you use Fusidic Acid on the face. The crea Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fusidic Acid 2% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2 % cream. Each gram contains 20 mg fusidic acid. Excipient(s) with known effect: Butylhydroxyanisole 0.04 mg/gram, Cetyl alcohol 111.00 mg/gram, and Potassium sorbate 2.70 mg/gram. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White, homogenous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of non-severe, superficial, non-extensive, primary and secondary skin infections caused by microorganisms that are sensitive to fusidic acid, especially of infections caused by Staphylococcus (see section 5.1). Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma. Also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts/abrasions. Consideration should be given to official guidance on the appropriate use of antibacterial agents._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND PAEDIATRIC POPULATION: Uncovered lesions: apply gently three or four times daily. Covered lesions: less frequent applications may be adequate. 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 fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Fusidic acid should not be used in infections caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa, see section 5.1. Extended or recurrent use may increase the risk of developing contact sensitisation. Extended treatment of very large surfaces should be avoided, in particular Llegiu el document complet