EPHYNAL Tablets 50 Milligram

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

TOCOPHERYL ACETATE

Dostępny od:

Bayer PLC

Dawkowanie:

50 Milligram

Forma farmaceutyczna:

Tablets

Data autoryzacji:

2005-07-29

Charakterystyka produktu

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�