Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone acetate; Clotrimazole
DE Pharmaceuticals
D01AC20
Hydrocortisone acetate; Clotrimazole
10mg/1gram ; 10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
Brand: Range: Product: Pack Type: Pack Size: Action: Date: Country: Barcode 1 Type: Barcode 1 Mag: Barcode 2 Type: Barcode 2 Mag: Pharmacode No/NE: Canesten Cream Clotrimazole and Hydrocortisone Leaflet UK Cutter Guides Technical & Non Printing Items BAYER ARTWORK PANEL 30 g Main Text (body copy): Height (based on lower case x): 7.75 pt 1.5 mm FONT SIZE PANEL 1 LTH PANTONE 485 C 2 LTH PANTONE Cool Gray 11 C 3 LTH Process Black Colours 27/08/19 J N/A N/A N/A N/A N/A READ ALL OF THIS LEAFLET CAREFULLY 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 p harmacist. • This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. • If you have any unusual effects after using this p roduct, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten HC Cream and what is it used for? 2. Before you use Canesten HC Cream 3. How to use Canesten HC Cream 4. Possible side effects 5. How to store Canesten HC Cream 6. Further Information 1. WHAT IS CANESTEN ® HC CREAM AND WHAT IS IT USED FOR? Canesten HC Cream is used to treat fungal skin infections when there are additional symptoms of inflammation (such as swelling, redness and itching). Canesten HC Cream treats the fungal skin infection and reduces the swelling and itching caused by it. Canesten HC Cream is used for the treatment of infection and irritation of the vulva or end of the penis (glans) caused by thrush. It is also used to treat nappy rash and fungal infection of the breast fold (intertrigo), as well as infections such as ringworm and athlete’s foot. The active substances in Canesten HC Cream are clotrimazole and hydrocortisone acetate. Clotrimazole belongs to a group of medicines called imidazoles which destroy the fungi and some bacteria that cause skin infections. Hydrocortisone acetate is a mild steroid which reduces swelling, redness and itching associated with inflammation of the skin. 2. BEFORE Y Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten HC Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 10mg clotrimazole and 11.2mg hydrocortisone acetate (equivalent to 10mg hydrocortisone). Excipient with known effect: Cetostearyl alcohol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten HC is indicated for the treatment of the following skin infections where co-existing symptoms of inflammation, e.g. itching, require rapid relief: a) All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi. b) All dermatomycoses due to yeasts (Candida species). c) Skin diseases showing secondary infection with these fungi. d) The treatment of nappy rash where infection due to Candida albicans is present. Candidal vulvitis, candidal balanitis and candidal intertrigo. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Canesten HC Cream should be thinly and evenly applied to the affected area twice daily and rubbed in gently. Treatment should be for a maximum of 7 days. A total daily dose of 10 mg cream per kg body weight should not be exceeded. For an adult weighing 50 kg the maximum daily dose is 500 mg cream which equals approximately 2 cm of cream to be divided into 2 applications per day. There is no separate dosage schedule for the elderly or the young. However, long-term therapy to extensive areas of skin should be avoided particularly in infants and children. Treatment duration: If the acute symptoms have subsided after about 7 days but treatment is still required, this may be carried out with the corticoid-free preparation intended for this purpose. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Use on broken skin - Diseases affecting the skin (e.g. acne, rosacea, perioral dermatitis, lues, tuberculosis, etc.) - Any untreated bacterial skin diseases - Viral skin di Διαβάστε το πλήρες έγγραφο