EPHYNAL Tablets 50 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TOCOPHERYL ACETATE

Available from:

Bayer PLC

Dosage:

50 Milligram

Pharmaceutical form:

Tablets

Authorization date:

2005-07-29

Summary of Product characteristics

License
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