For doctors
What is it and how is it used?
Vedrop contains vitamin E (in the form of tocofersolan). It is used to treat vitamin E deficiencies due to digestive malabsorption in children and adolescents suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine).

What do you have to consider before using it?
Do not take Vedrop
If you are allergic (hypersensitive) to vitamin E (d-alpha-tocopherol) or to any of the other ingredients of Vedrop (see section 6 „What Vedrop contains-).
Take special care with Vedrop
You should tell your doctor if you have:
-Problems with your kidney or dehydration. Vedrop should be used with caution and your kidney function closely monitored, because polyethylene glycol, part of the active substance tocofersolan, may damage your kidneys. When taking Vedrop, your doctor will perform regular tests to check the function of your kidneys.
-Problems with your liver. Vedrop should be used with caution and liver functions closely monitored.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Tell your doctor or pharmacist if you are taking:
-Certain medicines to thin the blood (oral anticoagulants such as warfarin). Your doctor will ask you to perform blood tests regularly and may adjust their dose to avoid higher risk of bleeding. - Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine). As Vedrop may enhance their intestinal absorption, your doctor will monitor the treatment effect and adjust the doses if necessary.
Taking Vedrop with food and drink
You can take Vedrop before or during your meal, with or wihout water.
Pregnancy and breast-feeding
No clinical data are available on exposure to this medicine during pregnancy. Please inform your doctor if you are pregnant as he/she will decide if the medicine may be used.
There is no data on whether or not this medicine is present in the breast milk. Please inform your doctor if you want to breast-feed and he/she will decide if the medicine may be used.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Vedrop
This medicine contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially „sodium- free-. It also contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially „potassium- free-.
How is it used?
Always take Vedrop exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For chronic cholestasis, the usual dose is 0.34 ml/kg/day.
The dose will be adjusted by your doctor according to your vitamin E blood level.
Method of administration
Vedrop should be swallowed with or without water. It should be used only with the oral syringe provided in the box.
To measure the dose:
If you take more Vedrop than you should
If you take large doses of Vitamin E, you may experience temporary diarrhoea and abdominal pain.
If you forget to take Vedrop
Skip the missed dose and go back to the regular dosing schedule.Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Vedrop can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
The following side effects were reported:
Common side effects
Diarrhoea
Uncommon side effects
Fatigue (feeling of weakness)
Headache
Loss of hair
Itching
Rash (eruption on the skin)
Abnormal level of sodium in the bloodAbnormal level of potassium in the blood
Increase of transaminases liver enzymes
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


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For doctors
What is it?
Vedrop is an oral solution that contains the active substance tocofersolan.
What is it used for?
Vedrop is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut. Bile is a fluid produced in the liver that helps to absorb fats from the gut.
The medicine can only be obtained with a prescription.
How is it used?
Treatment with Vedrop should be started and supervised by a doctor who has experience in treating patients with congenital or hereditary chronic cholestasis.
Vedrop is given by mouth, with or without water. The recommended daily dose is 0.34 ml per kilogram body weight. This dose should be adjusted depending on the amount of vitamin E in the child’s blood. This should be checked regularly.
How does it work?
Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet. It has a number of actions in the body, including protecting the nervous system from damage. Because vitamin E is soluble in fats and not water, it can only be absorbed from the gut into the body alongside fat particles. Patients with cholestasis may have low vitamin E levels because they have problems absorbing fats from the gut.
The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol. Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency.
How has it been studied?
The effects of Vedrop were first tested in experimental models before being studied in humans.
To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years. The patients all had vitamin E deficiency that was not responding to other vitamin E treatments given by mouth. The main measures of effectiveness were the level of vitamin E in the blood and the number of children whose neurological symptoms improved or stayed the same.
The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the eva luation of the medicine.
What benefits has it shown during the studies?
The studies showed that Vedrop could correct vitamin E levels in patients with chronic cholestasis and that it might improve or prevent neurological symptoms, especially in patients aged below three years.
What is the risk associated?
The most common side effect with Vedrop (seen in between 1 and 10 patients in 100) is diarrhoea. For the full list of all side effects reported with Vedrop, see the Package Leaflet.
Vedrop should not be used in people who may be hypersensitive (allergic) to tocofersolan or any of the other ingredients. It must not be used in premature babies.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vedrop’s benefits are greater than its risks for vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region. The Committee recommended that Vedrop be given marketing authorisation.
Vedrop has been authorised under ‘Exceptional Circumstances’. This means that because the disease is rare, it has not been possible to obtain complete information about Vedrop. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
How has it been studied?

The company that makes Vedrop will work with other companies to assess the possible effects of propylparaben (a preservative used in Vedrop) on the reproductive organs. The company will also set up a registry of patients with congenital or hereditary chronic cholestasis.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop to Orphan Europe S.A.R.L. on 24 July 2009.
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Name
Vedrop 50 mg/ml oral solution
Composition
Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Excipients:
Each ml contains 3 mg sodium methyl parahydroxybenzoate (E219), 0.90 mg sodium propyl parahydroxybenzoate (E217), 0.03 mmoles of potassium and 0.14 mmoles of sodium.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Oral solution.
Slightly viscous, pale yellow solution.
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