البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
KETOCONAZOLE
DEVRIES & CO. LTD
D01AC08
CREAM
KETOCONAZOLE 20 MG/G
TOPICAL
Required
STADA ARZNEIMITTEL AG, GERMANY
KETOCONAZOLE
KETOCONAZOLE
For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.
2014-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Nizoral ® Cream Active ingredient and its concentration ketoconazole 20 mg/gr Inactive and allergenic ingredients in the preparation – see in section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information”. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of fungal infections of the skin, cutaneous candidosis, tinea versicolor and seborrheic dermatitis. Therapeutic group: An antifungal preparation from the imidazole group. 2. BEFORE USING THE MEDICINE Do not use the medicine: • If you are sensitive (allergic) to the active ingredient ketoconazole or to any of the additional ingredients contained in the medicine. For the list of additional ingredients, see section 6 “Further information”. • To treat eye inflammations. Do not use this medicine if any of the above apply to your condition. If you are not sure, consult the doctor or pharmacist before using the medicine. Special warnings regarding use of the medicine Before using Nizoral Cream, tell the doctor if • You recently used a cream, ointment or lotion containing steroids on your skin infection • Continue applying a mild steroid (such as hydrocortisone) cream, ointment or lotion in the morning whilst applying Nizoral Cream in the evening. The mild steroid treatment can then be gradually stopped over a period of 2-3 weeks. If you have any questions about stopping your steroid cream, ointment or lotion, consult a doctor or pharmacist. Children and اقرأ الوثيقة كاملة
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nizoral Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoconazole 2% w/w (each gram of cream contains 20 mg). For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 Therapeutic indications For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporom spp and Epidermophyton spp. Nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp. 4.2 Posology and method of administration Ketoconazole cream is for use in adults. Cutaneous candidosis, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pityriasis) versicolor: it is recommended that Nizoral Cream be applied once or twice daily to cover the affected and immediate surrounding area. The usual duration of treatment is: tinea versicolor 2-3 weeks, yeast infections 2-3 weeks, tinea cruris 2-4 weeks, tinea corporis 3-4 weeks, tinea pedis 4-6 weeks. Seborrhoeic dermatitis: Nizoral cream should be applied to the affected area once or twice daily. The usual initial duration of treatment in seborrhoeic dermatitis is 2 to 4 weeks. Maintenance therapy can be applied intermittently (once weekly) in seborrhoeic dermatitis. Treatment should be continued until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Seborrhoeic dermatitis is a chronic condition and relapse is highly likely. Method of administration: Cutaneous administration. Paediatric patients The safety and efficacy of Nizoral Cream in children (17 years of age and younger) has not been established. P اقرأ الوثيقة كاملة