Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
METRONIDAZOLE
Sanofi-Aventis Ireland Limited
1% w/w %w/w
Cream
1997-05-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Noritate 1% w/w cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metronidazole 10mg/g (1%w/w) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream. A white to creamy-white cream with soft consistency. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of rosacea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly): _Noritate should be applied once daily, for eight weeks, to the affected areas of freshly cleansed skin. Further treatment may be necessary depending on the severity of the condition. _Children: _It is not recommended for paediatric patients (aged 16 years and under). 4.3 CONTRAINDICATIONS Noritate is contraindicated in individuals who have shown hypersensitivity to metronidazole, parahydroxybenzoates or any of the other ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Metronidazole has been reported to cause watering of the eyes, therefore contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use temporarily until further instructed. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or a history of, blood dyscrasia. Exposure to strong sunlight or UV light should be avoided. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/08/2008_ _CRN 2054968_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interaction Прочитайте повний документ