Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ketoconazole
Lexon Pharmaceuticals (Ireland) Limited
D01AC; D01AC08
Ketoconazole
20 milligram(s)/gram
Cream
Imidazole and triazole derivatives; ketoconazole
2017-06-16
NIZORAL 20MG/G CREAM ketoconazole Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However you still need to use Nizoral Cream carefully to get the best results from it. * 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 any of the side effects get serious or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist. IN THIS LEAFLET What Nizoral Cream is and what it is used for. Before you use Nizoral Cream How to use Nizoral Cream Possible side effects How to store Nizoral Cream Further information 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. 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 condition flaring up while Nizoral Cream starts to work. If you have any questions about stopping your steroid lotion or cream, SPEAK TO YOUR DOCTOR OR PHARM Read the complete document
Health Products Regulatory Authority 23 February 2022 CRN00CT8T Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nizoral 20 mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoconazole 2% w/w (each gram of cream contains 20mg). Excipients with known effect: propylene glycol, stearyl alcohol, cetyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from Romania_ White odourless cream 4 CLINICAL PARTICULARS As per PA0330/041/002 5 PHARMACOLOGICAL PROPERTIES As per PA0330/041/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS purified water, propylene glycol cetyl alcohol, stearyl alcohol, sorbitan monostearate, polysorbate 60 and 80 suphite anhydrous sodium (E221) isopropyl myristate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the tube and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Health Products Regulatory Authority 23 February 2022 CRN00CT8T Page 2 of 2 Do not store above 25°C 6.5 NATURE AND CONTENTS OF CONTAINER A lined aluminium tube, with a screw cap, containing 2 x15g of cream 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Harcourt Road Dublin 2 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/008/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 th June 2017 10 DATE OF REVISION OF THE TEXT February 2022 Read the complete document