Vitamin E has been reported to increase bleeding tendency in vitamin-K deficient patients or those taking anticoagulant treatments, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR) to detect any changes in haemostasis. A possible adjustment of the dose of anticoagulants during and after treatment with Vitamin E Suspension 100 mg/ml may be necessary (see section 4.5).
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 treatment, in particular women taking oral contraceptives containing oestrogens.
A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than 1.5kg) treated with vitamin E.
Vitamin E Suspension 100mg/ml contains benzoic acid which may increase jaundice in newborn babies, and polyoxyl castor oil which may cause stomach upsets and diarrhoea. Vitamin E Suspension 100mg/ml also contains propylene glycol, therefore co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. Vitamin E Suspension 100mg/ml also contains sucrose which may be harmful to the teeth; refer to section 4.3.
Serum levels of vitamin E should be monitored in cholestatic patients undergoing concurrent treatment with colestyramine (see section 4.5). The dose of vitamin E should be adjusted as necessary.
Vitamin E in dosages of greater than 4.5 mg/kg daily may delay the response to iron therapy in children with iron-deficiency anaemia. Iron concentrations should be monitored closely (see section 4.5).