Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
CLOTRIMAZOLE
BAYER ISRAEL LTD
D01AC01
CREAM
CLOTRIMAZOLE 1 %W/W
TOPICAL
Not required
KERN PHARMA S.L, SPAIN
CLOTRIMAZOLE
CLOTRIMAZOLE
For the treatment of fungal infections of the skin and mucosa caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur as well as skin infections caused by Corynebacterium minutissimum. Indicated also for Candida vulvitis and Candida balanitis.
2018-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription CANESTEN ® Cream Active ingredient: Clotrimazole 1% INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. Use this medicine according to the instructions in the section about dose in this leaflet. Consult a pharmacist if you need further information. Contact your doctor if your disease symptoms get worse or do not improve within 4 weeks. 1) WHAT IS THIS MEDICINE INTENDED FOR? Canesten ® cream is used to treat skin and mucous membrane infections caused by various types of fungi. It is also used to treat candida infection of the vagina and of the penis. THERAPEUTIC GROUP: imidazole antifungal agents for local use. 2) BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE: • If you are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine, including cetostearyl alcohol (see section 6, “Additional information”). • To treat fungal infection of the nails or on the scalp. SPECIAL WARNINGS ABOUT USING THE MEDICINE: Do not smoke or go near a source of naked flames due to the 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. As with other creams, Canesten ® cream may reduce the effectiveness of contraceptives made of rubber such as condoms or diaphragms. If you use this product in the vagina or on the penis, alternative contraceptives should be used for at least 5 days after using this product. If your condition has not im Lesen Sie das vollständige Dokument
1 NAME OF THE MEDICINAL PRODUCT Canesten Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% w/w. Excipients with known effect: Cetostearyl alcohol 100mg in each gram of cream, benzyl alcohol 20 mg in each gram of cream. 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 fungal infections of the skin and mucosa caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur as well as skin infections caused by Corynebacterium minutissimum. Indicated also for Candida vulvitis and Candida balanitis. 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. 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. 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). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation. 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. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Laboratory tests have suggested that, when used together, this product may cause da Lesen Sie das vollständige Dokument