Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole
Bayer Plc
D01AC01
Clotrimazole
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200; GTIN: 5010605106026
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Canesten Solution carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten Solution and what is it used for? 2. Before you use Canesten Solution 3. How to use Canesten Solution 4. Possible side effects 5. How to store Canesten Solution 6. Further information 1. WHAT IS CANESTEN ® SOLUTION AND WHAT IS IT USED FOR? Canesten Solution is used to treat fungal skin infections such as ringworm, athlete’s foot, fungal infected skin folds (intertrigo) and fungal infections of the outer and middle ear. IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST. The solution is particularly suitable for use on hairy skin. The active substance in Canesten Solution is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin and ear infections. 2. BEFORE YOU USE CANESTEN ® SOLUTION DO NOT USE CANESTEN SOLUTION: • If you are allergic (hypersensitive) to clotrimazole or the other ingredient of Canesten Solution, macrogol 400. USING OTHER MEDICINES: Canesten Solution and Sofradex drops may cause a heat reaction when used together. Consult your doctor before using these products together in the ear. PREGNANCY AND BREAST-FEEDING: If you are pregnant, breast-feeding or trying for a baby, tell your doctor or midwife before using Canesten Solution. If you have informed your doctor or midwife already, follow his/her instructions carefully. 3. HOW TO USE CANESTEN ® SOLUTION If Canesten Solution has been prescribed for you b Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Antifungal Cream Canesten Fungal Infection 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% w/w. Excipients with known effect: Cetostearyl alcohol 100mg in each gram of cream Benzyl alcohol 20mg in each gram of cream For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A white cream for cutaneous use 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of: (i) All dermatomycoses due to moulds and other fungi, (e.g. _Trichophyton_ species). (ii) All dermatomycoses due to yeasts (_Candida_ species). (iii) Skin diseases showing secondary infection with these fungi. (iv) Candidal nappy rash, vulvitis and balanitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten Antifungal Cream should be applied thinly 2 or 3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. Treatment should be continued for at least one month for dermatophyte infections and at least two weeks for candidal infections. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. There is no separate dosage schedule for the young or elderly. 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 This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The product also contains benzyl alcohol which may cause allergic reactions and mild local irritation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product. 4.6 FERTILITY, PREGNANCY Les hele dokumentet