Vedrop

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



 

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This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 
4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vedrop 50 mg/ml oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE 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 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl 
parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral solution. 
 
Slightly viscous, pale yellow solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with 
congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 
years of age. 
 
4.2 Posology and method of administration 
 
The treatment with Vedrop should be initiated and supervised by a physician experienced in the 
management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis. 
 
Bioavailability of vitamin E from Vedrop differs from that of other medicinal products. The dose should be 
prescribed in mg of d-alpha-tocopherol in the form of tocofersolan. Plasma vitamin E level should be 
monitored monthly for at least the first few months of therapy, thereafter at regular intervals and the dose 
adjusted accordingly if necessary.  
 
Posology 
The recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or 
hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of d-alpha-tocopherol in the form of 
tocofersolan). The dose should be prescribed in ml. 
 
The dose should be adjusted according to plasma vitamin E level. 
 



 

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To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) 
by 50. The result is the volume of Vedrop in ml: 
 

 
Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg) 

                     50 
 

 
The following table gives the volume of oral solution in function of patients’ weights. 
 

Weight (kg) Oral solution volume (ml) 

3 1.0 
4 1.4 
5 1.7 
6 2.0 
7 2.4 
8 2.7 
9 3.1 
10 3.4 
15 5.1 

 
 
Special populations 

Hepatic or renal impairment 

Experience with tocofersolan therapy in patients with renal impairment or underlying liver impairment has 
demonstrated no need to adapt the dose regimen of Vedrop (see section 4.4). 
 
Method of administration 
Vedrop is administered orally with or without water. The 1-ml or 2-ml oral syringes included in the 
container are designed to assist in measuring out the exact dose in accordance with the prescribed posology. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Vedrop must not be used in preterm newborn infants. 
 
4.4 Special warnings and precautions for use 
 
As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients 
or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time 
and international normalised ratio (INR). A possible adjustment of the dose of oral anticoagulant during and 
after treatment with Vedrop may be necessary. 
 
As data on patients with renal impairment are limited, Vedrop should be administered with caution and 
under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see 
section 4.2).  
 
Vedrop should be administered with caution in patients with underlying liver impairment and under close 
monitoring of the hepatic functions in such patients (see section 4.2). 
 
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate 
(E215) which may cause allergic reactions (possibly delayed). 



 

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This medicinal product contains sodium. It should be taken into consideration by patients on a controlled 
sodium diet. 
 
4.5 Interactions with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment 
(see section 4.4). 
 
Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other 
concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as 
steroids, antibiotics, antihistamines, cyclosporine, tacrolimus). Therefore, monitoring should be performed 
and, when necessary, doses should be adjusted. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
For tocofersolan no clinical data on exposed pregnancies are available. Animal studies do not indicate direct 
or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-
natal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.  
 
Breast-feeding 
It is unknown whether tocofersolan is excreted in human breast milk. The excretion of tocofersolan in milk 
has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to 
continue/discontinue therapy with Vedrop should be made taking into account the benefit of breast-feeding 
to the child and the benefit of tocofersolan therapy to the woman. 
 
Fertility 
No data is available 
 
4.7 Effects on ability to drive and use machines 
 
Vedrop has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly reported adverse reaction during treatment is diarrhoea. 
 
Tabulated list of adverse reactions 
Reported adverse reactions are listed below, by system organ class and by frequency.  
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10),  uncommon (≥ 1/1,000 to 
< 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the 
available data).  
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
 
 
 
 
 
 
 
 
 



 

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System organ class 
 

Adverse reactions 

Gastrointestinal disorders 
 

Common: diarrhoea 
Not known: abdominal pain 
 

Skin and subcutaneous tissue disorders 
 

Uncommon: alopecia, pruritus, rash 

General disorders and administration site 
conditions 
 

Uncommon: asthenia, headache 

Investigations 
 

Uncommon: serum sodium abnormal, serum potassium 
abnormal, transaminases increase 

 
 
Reporting of suspected adverse reactions 
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 the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.  
In case of overdose, a symptomatic treatment should be proposed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Vitamins, Other plain vitamin preparations; ATC code: A11HA08 
 
Vitamin E is the principal lipo-soluble antioxidant in the organism. It acts as a free radical chain breaking 
molecule, stopping the peroxidation of polyunsaturated fatty acids and it is involved in maintaining the 
stability and integrity of cell membranes. 
 
This medicinal product has been authorised under “exceptional circumstances”. This means that due to the 
rarity of the disease it has not been possible to obtain complete information on this medicinal product.  
The European Medicines Agency will review any new information which may become available every year 
and this SmPC will be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the 
active metabolite is the d-alpha-tocopherol. At low concentrations, tocofersolan forms micelles which 
enhance absorption of non-polar lipids such as fat-soluble vitamins. Its critical micellar concentration is low 
(0.04 to 0.06 mmol/l).  
 
The hydrolysis of tocofersolan occurs in the gut lumen. Taken up by cells, the alpha-tocopherol moiety 
appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular 
uptake does not require receptors, binding proteins or metabolic processes and does not occur by 
pinocytosis. Absorption of deuterated tocofersolan showed a normal pattern in lipoproteins: alpha-
tocopherol peaked first in chylomicrons, then in very low- density lipoproteins (VLDL) and finally in low-
density lipoproteins (LDL) and high-density lipoproteins (HDL), and the disappearance portions of the 
curves paralleled those in control subjects.  

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A study in 12 healthy volunteers compared tocofersolan with a water-miscible reference vitamin E after a 
single oral loading dose of 1200 IU. The relative bioavailability of tocofersolan tended to be higher (Frel of 
1.01 ± 1.74) with AUC0-t of 0.383 ± 0.203µM.h/mg, Cmax of 0.013 ± 0.006, tmax of 6.0 h (6.0 – 24.0), and t1/2 
of 29.7 h (16.0 – 59.5). 
 
In a similar study tocofersolan showed a higher bioavailability than a water-miscible reference vitamin E in 
paediatric patients with chronic cholestasis (n=6), absorption was significantly higher on both plasma 
concentration maximum increase (p=0.008) and AUC (p=0.0026). 
 
Distribution 
Located principally on cell membranes, within mitochondria and microsomes, vitamin E is ubiquitously 
distributed (red blood cells, brain, muscle, liver, platelets) and fat tissues are its major reservoir. 
 
Elimination 
Vitamin E is mainly eliminated in the bile (75%) and stools, either as free tocopherol or as oxidized forms. 
Urine represents a minor elimination route of vitamin E (as glucuro-conjugate). 
 
5.3 Preclinical safety data 
 
Non-clinical data in the literature reveal no special hazard for humans based on conventional studies of 
repeated dose toxicity, genotoxicity and toxicity to reproduction. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Potassium sorbate 
Sodium methyl parahydroxybenzoate (E219) 
Sodium ethyl parahydroxybenzoate (E215) 
Glycerol  
Disodium phosphate dodecahydrate 
Concentrated hydrochloric acid 
Purified water 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years. 
 
After first opening the bottle: 1 month. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions.  
 
6.5 Nature and contents of container 
 
Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal. Oral syringes with 
housing of LDPE and piston of polystyrol. Each bottle contains 10 ml, 20 ml or 60 ml of oral solution. 
 



 

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Boxes containing: 
 one 10 ml bottle and one 1 ml oral syringe 
 one 20 ml bottle and one 1 ml oral syringe 
 one 60 ml and one 2 ml oral syringe 

 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Doses for administration should be extracted from the bottle using the oral syringes which are provided in 
the pack. 
 
The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml. One graduation of the 1 ml oral 
syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan. 
 
The 2 ml oral syringe is graduated from 0.1 to 2 ml in steps of 0.1 ml. One graduation of the 2-ml oral 
syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Recordati Rare Diseases 
Immeuble “le Wilson”  
70 avenue du Général de Gaulle 
92800 Puteaux 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/533/001 10ml bottle 
EU/1/09/533/002 20ml bottle 
EU/1/09/533/003 60ml bottle 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 July 2009 
Date of latest renewal: 23 April 2014 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 



 

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ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE MARKETING 
AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 

 
 



 

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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Recordati Rare Diseases 
Immeuble “Le Wilson”  
70 avenue du Général de Gaulle 
92800 Puteaux 
France 
 
or 
 
Recordati Rare Diseases 
Eco River Parc 
30, rue des Peupliers 
F-92000 Nanterre 
France 
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
 
B.  CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
 
 Periodic Safety Update Reports  
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under 
Article 107c(7) of Directive 2001/83/EC and  published on the European medicines web-portal. 
 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 
USE OF THE MEDICINAL PRODUCT 
 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed 
RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the 
RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency;  
 Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result  
of an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same 
time. 
 
 



 

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E.  SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR 
THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
 
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) 
No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: 
 
 
Description Due date 
The MAH shall provide yearly updates on any new information concerning 
efficacy and safety of the product in patients with congenital chronic 
cholestasis or hereditary cholestasis. 

Yearly, simultaneously 
with submission of 
Periodic Safety Update 
reports 

 
 
 



 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

13 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton box – 10 ml, 20 ml and 60 ml bottle 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vedrop 50 mg/ml oral solution 
Tocofersolan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of 
tocopherol. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215). See the 
package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral solution. 
 
Bottle of 10 ml and 1 ml oral syringe. 
Bottle of 20 ml and 1 ml oral syringe. 
Bottle of 60 ml and 2 ml oral syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 

EXP 
 
Discard one month after first opening. 
 



 

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9. SPECIAL STORAGE CONDITIONS 
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Rare Diseases 
Immeuble “Le Wilson” 
70 avenue du Général de Gaulle 
92800 Puteaux 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/533/001 10 ml bottle 
EU/1/09/533/00 2 20 ml bottle 
EU/1/09/533/003 60 ml bottle 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vedrop 50 mg/ml 
  
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



 

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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
Bottle label – 10 ml, 20 ml and 60 ml bottles  
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vedrop 50 mg/ml oral solution. 
Tocofersolan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S)  
 
Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of 
tocopherol. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215). See the 
package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral solution. 
 
10 ml 20 ml 60 ml  
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard one month after opening 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Rare Diseases 
Immeuble “Le Wilson” 
70 avenue du Général de Gaulle 
92800 Puteaux 
France 
 
 
13. BATCH NUMBER 
 
EU/1/09/533/001 10 ml bottle 
EU/1/09/533/00 2 20 ml bottle 
EU/1/09/533/003 60 ml bottle 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vedrop 50 mg/ml 
 
  
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



 

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 

18 

Package leaflet: Information for the user 
 

Vedrop 50 mg/ml oral solution 
Tocofersolan 

 
This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 

 
Read all of this leaflet carefully before you start taking this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours. 
- If  you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet  
 
1. What Vedrop is and what it is used for 
2. What you need to know before you take Vedrop 
3. How to take Vedrop 
4. Possible side effects 
5. How to store Vedrop 
6. Contents of the pack and other information 
 
 
1. What Vedrop is and what it is used for 

 
Vedrop contains vitamin E (in the form of tocofersolan). It is used to treat lack of vitamin E due to digestive 
malabsorption (where nutrients from the food are not easily absorbed during digestion) in patients from birth 
(full term newborns) up to 18 years of age suffering from chronic cholestasis (a hereditary or congenital 
disease where bile cannot flow from the liver to the intestine). 
 
 
2. What you need to know before you take Vedrop 
 
Do not take Vedrop  
- If you are allergic to vitamin E (d-alpha-tocopherol) or any of the other ingredients of this medicine (listed 
in section 6). 
- Vedrop must not be used in newborn premature babies. 
 
Warnings and precautions  
Talk to your doctor before taking Vedrop 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.  

 Problems with your liver. Vedrop should be used with caution and liver functions closely monitored. 
 
Other medicines and Vedrop 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.  
 
 
 

http://en.wikipedia.org/wiki/Bile
http://en.wikipedia.org/wiki/Liver


 

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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 increase their absorption during digestion, your 
doctor will monitor the treatment effect and adjust the doses if necessary. 

 
Pregnancy and breast-feeding 
No clinical data are available on exposure to this medicine during pregnancy. 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. Inform your doctor if you 
want to breast-feed. Your doctor will help you decide what is best for you and your child. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
Vedrop is not likely to affect your ability to drive and use machines.  
 
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate 
(E215), which may cause allergic reactions (possibly delayed). 
 
Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml. Speak to your doctor if you are on a controlled 
sodium diet. 
 
 
3. How to take Vedrop 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
The usual dose is 0.34 ml/kg/day.  
Your doctor will prescribe the dose in ml. 
The dose will be adjusted by your doctor according to your vitamin E blood level. 
 
Method of administration 
Swallow the solution with or without water. Use only with the oral syringe provided in the box.  
You can take Vedrop before or during your meal, with or without water. 
 
To measure the dose: 
 

 
 
 
1- Open the bottle. 
2- Put the oral syringe included in the pack in 
the bottle. 

 

 



 

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3-Fill the oral syringe with the liquid by 
pulling the plunger up to the graduation mark 
corresponding to the quantity in millilitres 
(ml) prescribed by your doctor. 

 
 

 
4- Remove the oral syringe from the bottle. 
5- Empty the contents of the syringe by 
pushing the plunger to the bottom either: 

- directly into the mouth,  
or 
- into a glass of water and then drink the 
entire content of the glass. 

 
 

 
 
 
6- Close the bottle.  
7- Wash the syringe with water. 
 

 

 
 
 
If you take more Vedrop than you should 
If you take large doses of Vitamin E, you may experience temporary diarrhoea and stomach ache. Talk to 
your doctor or pharmacist if symptoms persist more than two days. 
 
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 stop taking Vedrop 
Do not stop the treatment without consulting your doctor because lack of vitamin E may come back and 
affect your health. Contact your doctor or pharmacist before stopping. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects were reported:  
 
Common side effects (may affect up to 1 in 10 people) 

 Diarrhoea 
 
 
 
 



 

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Uncommon side effects (may affect up to 1 in 100 people) 
 Asthenia (feeling of weakness)  
 Headache 
 Loss of hair 
 Itching 
 Rash (eruption on the skin) 
 Abnormal level of sodium in the blood 
 Abnormal level of potassium in the blood 
 Increase of transaminases (liver enzymes) 

 
Not known (frequency cannot be estimated from the available data) 

 Stomach ache 
 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5 How to store Vedrop 
 
 Keep this medicine out of the sight and reach of children. 
 Do not use this medicine after the expiry date which is stated on the box and the bottle, after EXP. The 

expiry date refers to the last day of that month. 
 This medicine does not require any special storage conditions.  
 Discard the bottle one month after first opening, even if some solution remains.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Vedrop contains 
- The active substance is tocofersolan. Each ml of solution contains 50 mg of d-alpha-tocopherol in the 

form of tocofersolan, corresponding to 74.5 IU of tocopherol. 
- The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium 

ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 
ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified 
water. 

 
What Vedrop looks like and contents of the pack 
Vedrop is a slightly viscous pale yellow oral solution in a brown glass bottle which is closed with a child-
resistant cap. The bottles contain 10 ml, 20 ml or 60 ml of oral solution. Each box contains one bottle and 
one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle). 
 
Marketing Authorisation Holder 
Recordati Rare Diseases
Immeuble “Le Wilson” 
70 avenue du General de Gaulle 
92800 Puteaux 
France 
 
 

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Manufacturer 
Recordati Rare Diseases 
Immeuble “Le Wilson” 
70, avenue du Général de Gaulle 
F-92800 Puteaux 
France 
 
or 
 
Recordati Rare Diseases 
Eco River Parc 
30, rue des Peupliers 
F-92000 Nanterre 
France 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
 
Belgique/België/Belgien 
Recordati 
Tél/Tel: +32 2 46101 36 

Lietuva 
Recordati AB. 
Tel: + 46 8 545 80 230 
Švedija 
 

България 
Recordati Rare Diseases 
Teл.: +33 (0)1 47 73 64 58 
Франция  
 

Luxembourg/Luxemburg 
Recordati 
Tél/Tel: +32 2 46101 36 
Belgique/Belgien 
 

Česká republika 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Francie 
 

Magyarország 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Franciaország  
 

Danmark 
Recordati AB. 
Tlf : +46 8 545 80 230 
Sverige 
 

Malta 
Recordati Rare Diseases 
Tel: +33 1 47 73 64 58 
Franza 
 

Deutschland 
Recordati Rare Diseases Germany GmbH 
Tel: +49 731 140 554 0 

Nederland 
Recordati 
Tel: +32 2 46101 36 
België 
 

Eesti 
Recordati AB. 
Tel: + 46 8 545 80 230 
Rootsi 
 

Norge 
Recordati AB. 
Tlf : +46 8 545 80 230 
Sverige  
 

Ελλάδα 
Recordati Rare Diseases 
Τηλ: +33 1 47 73 64 58 
Γαλλία 
 

Österreich 
Recordati Rare Diseases Germany GmbH 
Tel: +49 731 140 554 0 
Deutschland 
 



 

23 

España 
Recordati Rare Diseases Spain S.L.U. 
Tel: + 34 91 659 28 90 

Polska 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Francja  
 

France 
Recordati Rare Diseases 
Tél: +33 (0)1 47 73 64 58 

Portugal 
Jaba Recordati S.A. 
Tel: +351 21 432 95 00 

Hrvatska 
Recordati Rare Diseases 
Tél: +33 (0)1 47 73 64 58 
Francuska 
 

România 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Franţa  
 

Ireland 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58
France  

Slovenija 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Francija  
 

Ísland 
Recordati AB. 
Simi:+46 8 545 80 230 
Svíþjóð 
 

Slovenská republika 
Recordati Rare Diseases 
Tel: +33 (0)1 47 73 64 58 
Francúzsko  
 

Italia 
Recordati Rare Diseases Italy Srl 
Tel: +39 02 487 87 173 
 

Suomi/Finland 
Recordati AB. 
Puh/Tel : +46 8 545 80 230 
Sverige 
 

Κύπρος 
Recordati Rare Diseases 
Τηλ : +33 1 47 73 64 58 
Γαλλία 
 

Sverige 
Recordati AB. 
Tel : +46 8 545 80 230 
 

Latvija 
Recordati AB. 
Tel: + 46 8 545 80 230 
Zviedrija 
 

United Kingdom 
Recordati Rare Diseases UK Ltd. 
Tel: +44 (0)1491 414333 

 
This leaflet was last revised in  
 
This medicine has been authorised under “exceptional circumstances”. This means that because of the rarity 
of this disease it has been impossible to get complete information on this medicine.  
The European Medicines Agency will review any new information on this medicine every year and this 
leaflet will be updated as necessary. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
	A. LABELLING
	B. PACKAGE LEAFLET