Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fusidic acid; Hydrocortisone acetate
LEO Pharma
D07CA01
Fusidic acid; Hydrocortisone acetate
20mg/1gram ; 10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5702191001020 5702191005004
FOR AN ADULT: FOR A CHILD UNDER 11 YEARS: IF YOU FORGET TO USE FUCIDIN H CREAM If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fucidin H Cream can cause side effects, although not everybody gets them. IMPORTANT SIDE EFFECTS TO LOOK OUT FOR: YOU MUST GET URGENT MEDICAL HELP IF YOU HAVE ANY OF THE FOLLOWING SYMPTOMS. YOU MAY BE HAVING AN ALLERGIC REACTION: ● YOU HAVE DIFFICULTY BREATHING ● YOUR FACE OR THROAT SWELL ● YOUR SKIN DEVELOPS A SEVERE RASH. OTHER POSSIBLE SIDE EFFECTS: Any of the problems listed below are more likely if the medicine is used for a long time, in large amounts or on skin folds (such as armpits or under breasts). These problems are more likely in babies and children. They are also more likely if the skin is covered with a dressing, bandage or nappy. SKIN PROBLEMS COMMON SIDE EFFECTS (MAY AFFECT UP TO 1 IN 10 PEOPLE) ● Application site reaction (including itching, burning and irritation). UNCOMMON SIDE EFFECTS (MAY AFFECT UPTO 1 IN 100 PEOPLE) ● Itchy rash and skin inflammation in the area where the medicine is used ● Worsening of your eczema. ● Skin rash FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM THE AVAILABLE DATA. ● Blurred vision Some side effects are known to be caused by hydrocortisone (steroid), one of the ingredients in Fucidin H Cream. You should tell your doctor if any of the side effects occur: ● Adrenal glands may stop working properly. Signs are tiredness, depression and anxiety. ● Glaucoma ● Thinning of the skin ● Red spotty rash around the mouth or chin ● Stretch marks ● Small veins near the surface of the skin become visible ● Skin redness ● Lightening of your skin colour ● Changes in the growth of your body hair ● Excessive sweating REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. T Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucidin H cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fucidin H cream contains fusidic acid Ph.Eur.2% and hydrocortisone acetate Ph.Eur.1%. Excipients with known effect Butyl hydroxyanisole E320 (40 microgram/g), cetyl alcohol (111 mg/g) and potassium sorbate E202 (2.7 mg/g). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream for topical administration 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fucidin H cream is indicated in eczema and dermatitis with secondary bacterial infections, including atopic eczema, primary irritant dermatitis and allergic and seborrhoeic dermatitis where the organisms responsible are known to be or believed to be sensitive to fusidic acid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children: Uncovered lesions - a small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. Covered lesions - less frequent applications may be adequate. 4.3 CONTRAINDICATIONS Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucidin H cream is contraindicated in the following conditions: Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4). Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term continuous topical therapy with Fucidin H cream should be avoided. Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin H cream. Due to the content of corticosteroid, Fucidin H cream should be used with care near the eyes. Avoid getting Fucidin H cream into the eyes (see s Aqra d-dokument sħiħ