Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
TOCOPHERYL ACETATE
Bayer PLC
50 Milligram
Tablets
2005-07-29
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ephynal Tablets 50 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet White to pale cream coloured cylindrical biconvex tablet imprinted ‘Ephynal 50’ on one face with a single break bar on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the correction of vitamin E deficiency occurring in malabsorption disorders ie: • Cystic fibrosis • Chronic cholestasis • Abetalipoproteinaemia 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Posology: These tablets are for oral administration. Adults: For the treatment of malabsorption disorders the following doses should be administered: Cystic fibrosis 100-200 mg/day Abetalipoproteinaemia 50-100 mg/kg/day Elderly: The adult dose is appropriate. Children: For the treatment of cystic fibrosis a dose of 50 mg/day should be given to children less than 1 year and 100 mg/day to children 1 year and over. The adult dosage should be used for the treatment of abetalipoproteinaemia (50-100 mg/kg/day). Infants with vitamin E deficiency which is secondary to chronic cholestasis may be treated with doses of 150-200 mg/kg/day. 4.3 CONTRAINDICATIONS Known hypersensitivity to vitamin E. D, L-Alpha Tocopherol Acetate 50.0 mg Used as Vitamin E 5% adsorbate comprising of: D, L-Alpha Tocopherol Acetate and 51.5 % w/w Silica precipitated FK320 48.5 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/03/2006_ _CRN 2020611_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition, including patients taking oestrogens. This finding has not been confirmed but should be borne in mind when selecting patients for Lees het volledige document