Summary of medicine characteristics - VITAMIN E SUSPENSION 100 MG / ML
Vitamin E Suspension 100mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of suspension contains 500mg of DL-alpha-tocopheryl acetate.
Excipients with known effect:
Each 5ml of suspension contains 1 g of sucrose,10 mg of benzoic acid, 13.99mg of propylene glycol and 400 mg of polyoxyl castor oil
For the full list of excipients, see section 6.1
Oral Suspension
4.1 Therapeutic indications
For the correction of Vitamin E deficiency occurring in malabsorption disorders ie. cystic fibrosis, chronic cholestasis and abetalipoproteinaemia.
4.2 Posology and method of administration
Route of administration: For oral use.
Adults (including the elderly)
For the treatment of malabsorption disorders the following doses should be administered:
Cystic fibrosis
100–200mg/day
50–100mg/kg/day
Abetalipoproteinaemia
Children
For the treatment of cystic fibrosis a dose of 50mg/day should be given to children less than 1 year and 100mg/day to children 1 year and over. The dose should be adjusted to maintain serum a-tocopherol:cholesterol ratio above 5.4 mg/g. Serum levels should be monitored at least annually and 3–6 months after a dosage change.
The adult dosage should be used for the treatment of abetalipoproteinaemia (50–100mg/kg/day).
Infants with vitamin E deficiency which is secondary to chronic cholestasis may be treated with doses of 150–200mg/kg/day.
Vitamin E blood levels should be measured at regular intervals and doses adjusted accordingly.
For instructions on dilution of Vitamin E before administration, see section 6.6.
4.3 Contraindications
Use in patients with a known hypersensitivity to Vitamin E.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.4 Special warnings and precautions for use
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).
4.5 Interaction with other medicinal products and other forms of interaction
Vitamin E may increase the risk of haemorrhage in patients taking anticoagulants (see section 4.4).
Vitamin E may increase the risk of thrombosis in patients taking oestrogens (see 4.4 above).
Colestyramine may reduce the absorption of vitamin E (see section 4.4).
Iron: Limited data suggest that excessive doses of vitamin E (>4.5 mg/kg/day) can delay the red blood cell response to iron supplements in severely anaemic infants, and that low-birth weight infants treated with iron supplements may develop vitamin Edeficiency haemolytic anaemia. High doses of vitamin E should be avoided in infants. It is not known if this interaction occurs in adults (see section 4.4).
4.6 Fertility, Pregnancy and lactation
There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from animal work that it is free from hazard, therefore do not use in pregnancy especially in the first trimester. No information is available on excretion in breast milk, therefore it is advisable not to use during lactation.
4.7 Effects on ability to drive and use machines None known.
4.8 Undesirable effects
Diarrhoea and abdominal pain may occur with doses greater than 1g daily.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseTransient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other plain vitamin preparations
ATC code: A11HA03
The exact role of vitamin E in the animal organism has not yet been established. Vitamin E is known to exert an important physiological function as an antioxidant for fats, with a sparing action on vitamin A, carotenoids and on unsaturated fatty acids. Other work has demonstrated that vitamin E is connected with the maintenance of certain factors essential for the normal metabolic cycle.
5.2 Pharmacokinetic properties
Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.
5.3 Preclinical safety data
5.3 Preclinical safety dataThere are no pre-clinical data of relevance to the prescriber which are additional to that already in other sections of the SPC.
6.1
Polyoxyl castor oil Benzoic acid E210 Sorbic acid
Sucrose
Glycerol
Purified Water
Raspberry flavour containing:
Propylene glycol E1520
Natural flavourings Purified water.
6.2 Incompatibilities
None.
6.3 Shelf life
| Unopened: | Two years. |
| After first opening: | One month (The product will be stable after opening for the normal duration of treatment providing the cap is replaced after use and the recommended storage conditions on the label are observed). |
6.4 Special precautions for storage Store below 25°C.
6.5 Nature and contents of container
100ml Amber glass bottles with an HDPE child resistant and tamper evident cap with a polypropylene inner and EPE wad.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
Vitamin E Suspension may be diluted with Syrup BP but should be used immediately and not stored.