Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bifonazole
Bayer Plc
D01AC10
Bifonazole
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200; GTIN: 5010605055119
Brand: Range: Product: Pack Type: Pack Size: Action: Date: Country: CAD Ref No: Printer: Substrate: Barcode 1 Type: Barcode 1 Mag: Barcode 2 Type: Barcode 2 Mag: Pharmacode No/NE: PIL 148 x 210 (P041) Canesten Cream Bifonazole Leaflet UK Cutter Guides Technical & Non Printing Items BAYER ARTWORK PANEL 20 g Main Text (body copy): Height (based on lower case x): 7.25 pt 1.42 mm FONT SIZE PANEL 1 LTH PANTONE 485 C 2 LTH Process Black 3 LTH PANTONE Cool Gray 11 C Colours 08/11/19 L N/A N/A N/A N/A N/A Generic Bayer White Paper CANESTEN BIFONAZOLE ONCE DAILY ATHLETE'S FOOT 1% W/W CREAM Bifonazole 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 Bifonazole Once Daily Athlete’s Foot 1% w/w cream 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 or pharmacist if your symptoms worsen or do not improve within 7 days. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten Bifonazole Once Daily cream and what is it used for? 2. Before you use Canesten Bifonazole Once Daily cream 3. How to use Canesten Bifonazole Once Daily cream 4. Possible side effects 5. How to store Canesten Bifonazole Once Daily cream 6. Further information 1. WHAT IS CANESTEN ® BIFONAZOLE ONCE DAILY CREAM AND WHAT IS IT USED FOR? Canesten Bifonazole Once Daily cream is an effective once daily treatment of athlete's foot. IF YOU ARE UNSURE WHETHER YOU HAVE ATHLETE'S FOOT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST. The active substance in Canesten Bifonazole Once Daily cream is bifonazole. Bifonazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin infections. 2. BEFORE YOU USE CANESTEN ® BIFONAZOLE ONCE DAILY CREAM DO NOT USE CANESTEN BIFONAZOLE Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Bifonazole Once Daily 1% w/w Cream Canesten Bifonazole Once Daily Athlete’s Foot 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The cream contains 1% w/w bifonazole. Excipient with known effect: cetostearyl alcohol. For excipients see section 6.1. 3 PHARMACEUTICAL FORM A white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of athlete’s foot. The preparation is not for vaginal use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The cream should be thinly applied and rubbed into the affected areas once daily, preferably at night before retiring, for two to three weeks. The affected areas should be washed and dried thoroughly before the cream is applied. A physician or pharmacist should be consulted if symptoms do not improve within seven days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Treatment of infants with nappy rash. Treatment of nail and scalp infections. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). If unsure of diagnosis, the patient should seek the advice of a doctor or pharmacist before using this product. Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole-containing products with caution. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy they should be appropriately monitored. Closer monitoring may be required in cases of occlusion and/or application to a large surface area or to broken and damaged skin. 4.6 FERTILITY, PREGNANCY AND LACTATION PREGNANCY There are no clinical data from the use of bifonazole in pregnant wom Lue koko asiakirja