Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
AZATADINE MALEATE
Schering-Plough Limited
500mcg/5ml MG/5ml
Unknown
1979-01-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optimine Syrup oral solution 500 mcg/5 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of solution contains azatadine maleate 500 micrograms. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral solution. A clear, colourless, blackcurrant flavoured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of allergic conditions such as hayfever, vasomotor rhinitis, urticaria, pruritus of allergic origin and allergic reactions associated with insect bites and stings. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Adults, the elderly and children over the age of 12 years : _- 1mg of azatadine maleate (10ml of syrup) in the morning and evening is recommended. In refractory or more severe cases, 2mg (20ml) may be used. _Children (6-12 years):_ 0.5 - 1.0mg azatadine maleate (5 - 10ml syrup), twice daily. Optimine Syrup may be diluted with syrup BP. Method of administration : Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or any of the other constituents. Monoamine oxidase inhibitors, which are known to intensify or prolong the anticholinergic and sedative action of drugs, should not be used concomitantly with azatadine maleate. Due to the anticholinergic effect of azatadine maleate, the drug should be used with caution in patients with prostatic hypertrophy, urinary retention, glaucoma, stenosing peptic ulcer or pyloroduodenal obstructions. Patients with rare hereditary problems of fructose intolerance should not take this medicine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/12/2005_ _CRN 2017838_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER F Citiți documentul complet