Pajjiż: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FUSIDIC ACID; HYDROCORTISONE ACETATE
DKSH MALAYSIA SDN BHD
FUSIDIC ACID; HYDROCORTISONE ACETATE
mcg/mL
LEO Laboratories Ltd
FUCIDIN ® H CREAM Fusidic acid / Hydrocortisone acetate (20mg/g / 10 mg/g) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Fucidin ® H Cream is used for 2. How Fucidin ® H Cream works 3. Before you use Fucidin ® H Cream 4. How to use Fucidin ® H Cream 5. While you are using Fucidin ® H Cream 6. Side effects 7. Storage and disposal of Fucidin ® H Cream 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT FUCIDIN ® H CREAM IS USED FOR It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a skin disease accompanied by inflammation reddening, exudation or scabs and itching, frequently of an allergic origin). You must talk to a doctor if you do not feel better or if you feel worse. HOW FUCIDIN ® H CREAM WORKS Fucidin ® H Cream combines the antibacterial action of Fusidic acid (antibiotic) with the anti-inflammatory effect of hydrocortisone acetate (corticoid). BEFORE YOU USE FUCIDIN ® H CREAM - _When you must not use it_ Do not use Fucidin ® H Cream ■ If your intention is to treat skin conditions caused by tuberculosis ■ If you are allergic to fusidic acid, hydrocortisone acetate or any of the other ingredients of Fucidin ® H Cream. ■ If you have a skin infection primarily caused by bacteria, fungi or virus (such as herpes or varicella). ■ If you have skin inflammation around the mouth. ■ If you have rosacea (severe flushing of the skin on the face). _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. Use during pregnancy and lactation should be evaluated and decided upon by a doctor. Fucidin ® H Cream should be used with caution during pregnancy. - There is inadequate evidence of safety in human pregnancy. Safety in mothers has not been established. Topical corticosteroids should not be applied to the breast prior to nursing. - _Be Aqra d-dokument sħiħ
145 mm 280 mm 80 mm Item-number: font: OCR-B, 8 pt., kerning +10., rotate 90% 000000-00 Fucidin ® Hcream Composition Active ingredients: Fusidic acid 20 mg/g, Hydrocortisone acetate 10 mg/g. Inactive ingredients: Butylated hydroxyanisole, Cetyl alcohol, Glycerol 85%, Liquid paraffin, Polysorbate, Potassium sorbate, White soft paraffin, all-rac-α-tocopherol, Hydrochloric acid, Purified water. Pack Sizes: 5g and 15g. Not all pack sizes are marketed. Pharmacology Pharmacodynamics: Fucidin ®H Cream combines the potent antibacterial action of fusidic acid with the anti-inflammatory effect of hydro cortisone acetate. When applied topically, Fucidin ®H is effective against staphylococci, streptococci, corynebacteria, Neisseria and certain Clostrida and Bacteroides. Pharmacokinetics: A study in rabbits has shown that the systemic absorption of Fucidin ®cream is negligble. Properties Fucidin ®H Cream combines the antibacterial action of fusidic acid with the anti-inflammatory effect of hydro cortisone acetate. Indications Fucidin ®H Cream is indicated for the treatment of dermatitis, including atopic dermatitis and contact dermatitis, where an infection with bacteria sensitive to fusidic acid is suspected or confirmed. Because of its hydrocortisone content, Fucidin ®H Cream is particularly appropriate in cases where a milder corticosteroid is indicated, including milder inflammatory dermatoses - on the face and on children’s skin. Fucidin ®H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits. Dosage Fucidin ®H cream should be applied 2-3 times daily on uncovered lesions. For covered lesions, less frequent application may be adequate. Contraindications Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the excipients listed above (see Composition). Due to the content of corticosteroid, Fucidin ®H is contraindicated in the following conditions: Primary skin infections caused by fungi, virus or bacteria, either un Aqra d-dokument sħiħ