Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
FUSIDIC ACID; HYDROCORTISONE ACETATE
LEO Pharma A/S
D07CA01
FUSIDIC ACID; HYDROCORTISONE ACETATE
CREAM
FUSIDIC ACID; HYDROCORTISONE ACETATE
POM
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
Authorised
2005-08-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIDIN ® H CREAM READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet 1. What Fucidin ® H is and what it is used for 2. Before you use Fucidin ® H cream 3. How to use Fucidin ® H cream 4. Possible side effects 5. How to store Fucidin ® H cream FUCIDIN ® H CREAM Active substance: Fusidic acid 20 mg/g and Hydrocortisone acetate 10 mg/g Other ingredients: Butylhydroxyanisole, cetyl alcohol, glycerol 85%, liquid paraffin, polysorbate 60, potassium sorbate, purified water, hydrochloric acid and white soft paraffin. PRESENTATION AND CONTENTS Tubes containing 15 g of cream 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 ® H CREAM IS AND WHAT IT IS USED FOR Fucidin ® H cream is a combination of an antibiotic and a corticosteroid. Fucidin ® H cream is used for the local treatment of bacterially induced eczemas or dermatitis caused by bacteria which are sensitive to fusidic acid. 2. BEFORE YOU USE FUCIDIN ® H CREAM FUCIDIN ® H CREAM MUST NOT BE USED DO NOT USE FUCIDIN ® H: - If you are allergic (hypersensitive) to fusidic acid or hydrocortisone acetate. - If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. - To treat a skin condition called acne rosacea. This is redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure. - To treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin. - To treat skin conditions caused by tuberculosi Olvassa el a teljes dokumentumot
Page 1 of 5 1. NAME OF THE MEDICINAL PRODUCT Fucidin H, 20 mg/g + 10 mg/g Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fusidic acid 20 mg/g and hydrocortisone acetate 10 mg/g. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Cream White water-miscible cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fucidin ® H cream is indicated in treatment of infected eczema and atopic dermatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: Uncovered lesions: apply gently three times daily for up to 2 weeks. Covered lesions: less frequent applications may be adequate. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients of Fucidin ® H Cream. Due to content of corticosteroid Fucidin ® H Cream is contraindicated in the following conditions: Skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea. 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE Long-term continuous corticosteroid treatment should be avoided, particularly in infants and children. The adrenocortical inhibition may occur even without using an occlusive dressing. Due to the content of corticosteroid use of Fucidin ® H Cream should be avoided in the following conditions: Atrophic skin, cutaneous ulcer, acne vulgaris, fragility of skin veins and perianal and genital pruritus. Due to the content of corticosteroid any contact with open wounds and mucous membranes should be avoided. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 2 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERA Olvassa el a teljes dokumentumot