Riik: Suurbritannia
keel: inglise
Allikas: 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: 5010605054853 5010605610509
ATHLETE'S FOOT 10/O W/W CREAM clotrimazole READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . This medicine is availab le wit hout prescription. However, you still need to use Canesten Athlete's Foot 1% w/w cream carefully to get the best results from it. • Keep this leaflet. You may need to read it aga i n. • Ask your pharmacist if you need more i nformation or adv i ce. • You must contact a doctor or pharmacist if your symptoms worsen or do not i mprove. • If you have any unusual effects after using this product, te ll your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten Ath l ete's Foot cream and what is it used _foe _ 2. Before you use Canesten Ath let e's Foot cream 3. How to use canesten Athlete 's Foot cream 4. Possible side effects 5. How to store Canesten Athlete 's Foot cream 6. Further i nformation 1. WHAT IS CANESTEN ® ATHLETE'S FOOT CREAM ANO WHAT IS IT USED FOR? Canesten Athlete 's Foot cream is an effective treatment for ath le te's foot or jock itch. If YOU ARE UNSURE WHETHER YOU HAVE ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST. The active substance IN Canesten Athlete 's Foot cream is clotrimazole. clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin i nfectio n s. 2. BEFORE YOU USE CANESTEN ® ATHLETE'S FOOT CREAM DO NOT USE CANESTEN ATHLETE'S FOOT CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingred i ents of Canesten Ath l ete's Foot cream (listed in section 6) including cetostearyl alcohol. • To treat na il or scalp i nfections. PREGNANCY AND BREAST-FEEDING: If you are pregnant or breast-feeding or trying fo r a baby, tell your doctor or mi dw ife before using I 871591 59 indd 1 Canesten Athlete 's Foot cream. If you have informed your doctor or midwife al ready, follow his/her instructions carefully. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS: This product contains cetostearyl a Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Dual Action 1% w/w Cream Canesten Athlete’s Foot 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% w/w. Excipient with known effect: cetostearyl alcohol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white cream for topical use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of tinea pedis and tinea cruris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION There is no separate dosage schedule for the young or elderly. The cream should be applied thinly 2-3 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. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. The treatment should be continued for at least one month to prevent re-infection; however a physician should be consulted if symptoms do not improve within 7 days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not use the cream to treat nail or 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). 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION Fertility: No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility. Pregnancy: There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy Lugege kogu dokumenti