देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
KETOCONAZOLE
Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium
D01AC08
KETOCONAZOLE
CREAM
KETOCONAZOLE 2 percent weight/weight
OTC
ANTIFUNGALS FOR DERMATOLOGICAL USE
Authorised
2007-03-02
PACKAGE LEAFLET: INFORMATION FOR THE USER NIZORAL® 20MG/G CREAM ketoconazole Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • 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 Nizoral cream is and what it is used for 2. What you need to know before you use Nizoral Cream 3. How to use Nizoral Cream 4. Possible side effects 5. How to store Nizoral Cream 6. Contents of the pack and other information 1. WHAT NIZORAL CREAM IS AND WHAT IT IS USED FOR Nizoral Cream is used to treat fungal infections of the skin which may appear on the hands, feet, genital area, trunk, groin, scalp, face, chest or back. These can be caused by a variety of fungi or yeasts and Nizoral Cream works by destroying the fungus that causes the infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NIZORAL CREAM This product is suitable for most adults, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS PRODUCT • If you have ever had an allergic (hypersensitivity) reaction to any of the ingredients. IF THIS APPLIES TO YOU, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING NIZORAL CREAM. PREGNANCY AND BREAST-FEEDING • You can use Nizoral Cream if you are pregnant, think you might be pregnant or are breast-feeding. TAKE SPECIAL CARE WITH NIZORAL CREAM • If you have been regularly using a lotion or cream, which contains a steroid (such as _betamethasone_ or _hydrocortisone_) to control your skin infection, you should wait for two weeks before starting treatment with Nizoral Cream. This will stop your conditio पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nizoral 20mg/g Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoconazole 2% w/w (each gram of cream contains 20 mg) Excipients; Propylene glycol, 20% w/w Stearyl alcohol, 7.5% w/w Cetyl alcohol, 2.0% w/w For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Cream White odourless cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nizoral cream is indicated 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, Microsporon _and _Epidermophyton species._ Nizoral cream is also indicated for the treatment of cutaneous candidosis (including external application in vulvitis), _Tinea (pityriasis) versicolor_ and in the treatment of seborrhoeic dermatitis, a skin condition related to the presence of _Malassezia furfur_ (previously called _Pityrosporum ovale_). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nizoral Cream is for use in adults For cutaneous administration Cutaneous candidosis, _Tinea _ _corporis, _ _Tinea _ _cruris, _ _Tinea _ _manus, _ _Tinea _ _pedis _ and _ _ _Tinea _ _(pityriasis) versicolor_ : it is recommended that Nizoral cream 2% 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 cruris2-4 weeks; Tinea corporis 3–4 weeks; Tinea pedis 4-6 weeks Seborrheic dermatitis: Nizoral cream 2% should be applied to the affected areas once or twice daily. The usual initial duration of treatment for seborrhoeic dermatitis is 2- to 4 weeks. Maintenance therapy can be applied (once weekly) in seborrheic 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. General measures in regard to hygiene should be observed to control sour पूरा दस्तावेज़ पढ़ें