Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOCONAZOLE
EUCOGEN SDN BHD
KETOCONAZOLE
1 tube x 10 gm
DAE HWA PHARMACEUTICAL CO., LTD.
COMOZOL CREAM 2%W/W _Ketoconazole_ (20mg per gram) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Comozol cream is used for 2. How Comozol cream works 3. Before you use Comozol cream 4. How to use Comozol cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Comozol cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT COMOZOL CREAM IS USED FOR Comozol cream is used for fungal and yeast infections of the skin in adults. Infections may appear on the: • Trunk, chest or back • Hands or feet • Scalp or face • Groin or genitals HOW COMOZOL CREAM WORKS Comozol cream works by killing the fungus that causes the infection. BEFORE YOU USE COMOZOL CREAM - _When you must not use it _ _ _ • If you are allergic to anything in Comozol cream • For eye infections Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Comozol cream. _ _ Pregnancy and breast-feeding There are no known risks with the use of COMOZOL cream in pregnancy or breast-feeding. _ _ _ _ - _Before you start to use it _ • Talk to your doctor or pharmacist before using this medicine • If you have recently used a cream, ointment or lotion on your skin infection that contains a steroid: You should continue to apply a mild steroid (such as hydrocortisone) cream, ointment or lotion in the morning whilst applying COMOZOL 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, ask your doctor or pharmacist. • Preparing your skin Wash the infected skin and dry it well - _Taking other medicines _ Comozol cream does not normally react with other medicines. However, tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medici Baca dokumen lengkap
COMOZOL CREAM 1. NAME OF THE MEDICAL PRODUCT COMOZOL cream 2% w/w 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: Ketoconazole…………………… 20mg 3. PHARMACEUTICAL FORM White and homogeneous cream 4. CLINICAL PARTICULARS 4.1 INDICATIONS Comozol Cream 2% is indicated for topical application in the treatment of dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manus, and tinea pedis due to _Trichophyton rubrum_ , _Trichophyton mentagrophytes_ , _Microsporum canis_ , and _Epidermophyton _ _floccosum_ , as well as in the treatment of cutaneous candidosis and tinea (pityriasis) versicolor. - Comozol Cream 2% is also indicated for the treatment of seborrhoeic dermatitis, a skin condition associated with the presence of _Malassezia furfur_ . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION - Cutaneous candidosis, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pityriasis) versicolor: it is recommended that Comozol Cream 2% be applied once daily to cover the affected and immediate surrounding area. - Seborrheic dermatitis: Comozol Cream 2% should be applied to the affected area once or twice daily. - 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. - The usual initial duration of treatment in seborrheic dermatitis is 2 to 4 weeks. Maintenance therapy is applied once or twice 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 of treatment. Special populations Paediatrics There are limited data on the use of ketoconazole 2% cream in paediatric patients. Administration Topical administration to the skin. For External Use Only. 4.3 CONTRAINDICATIONS COMOZOL Cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself. 4.4 SPECIAL W Baca dokumen lengkap