국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole
Kent Pharma (UK) Ltd
D01AC01
Clotrimazole
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOTRIMAZOLE CREAM 1% READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Clotrimazole is and what it is used for 2. What you need to know before you use Clotrimazole 3. How to use Clotrimazole 4. Possible side effects 5. How to store Clotrimazole 6. Contents of the pack and other information 1. WHAT CLOTRIMAZOLE IS AND WHAT IT IS USED FOR The active substance is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin infections. Clotrimazole is used to treat fungal skin infections such as ringworm, athlete’s foot, fungal nappy rash and fungal sweat rash. It is also used to relieve irritation of the vulva (external thrush) or the end of the penis, which may be associated with thrush. When Clotrimazole is applied to the infected area of skin it works by destroying the fungus or yeast which has caused the infection. IF YOU ARE UNSURE WHETHER YOU (OR YOUR BABY IF TREATING NAPPY RASH) HAVE ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLOTRIMAZOLE DO NOT USE CLOTRIMAZOLE: • if you (or your baby if treating nappy rash) are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Clotrimazole if you have used a cream containing clotrimazole or a similar med 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clotrimazole 1% Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tube contains 1%w/w Clotrimazole. Each 1 g of cream contains 10 mg of clotrimazole. Excipient with known effect: cetostearyl alcohol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cream A smooth white cream. 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). These include ringworm (tinea) infections (e.g. athlete’s foot), paronychia, pityriasis versicolor, erythrasma and intertrigo. iii. Skin diseases showing secondary infection with these fungi. iv. Candidal nappy rash, vulvitis and balanitis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology There is no separate dosage schedule for the young or elderly. Method of administration The cream should be applied thinly and evenly to the affected area 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 thoroughly washed and dried, especially between the toes, before applying the cream. Treatment should be continued for at least one month for dermatophyte infections, or for at least two weeks for candidal infections. . 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). Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 전체 문서 읽기