Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Vedrop 50 mg/ml oral solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tocofersolan may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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).
What you need to know before you take it
e 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. 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.
How to take it
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.
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 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
Possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system : Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
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.
Contents of the pack and other information
What Vedrop contains •
•
The active substance is tocofersolan. Each ml of solution contains 50 mg of d-alphatocopherol 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 – Manufacturer
Recordati Rare Diseases – Tour Hekla – 52 avenue du Général de Gaulle – 92800 Puteaux
- France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom – Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333
This leaflet was last revised in 12/2024. 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.
Frequently asked questions about Vedrop 50 mg/ml oral solution
How do I take Vedrop 50 mg/ml oral solution?
Vedrop 50 mg/ml oral solution comes as oral solution containing 50mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Vedrop 50 mg/ml oral solution?
The active substance in Vedrop 50 mg/ml oral solution is tocofersolan.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Vedrop 50 mg/ml oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Vedrop 50 mg/ml oral solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tocofersolan
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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.
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:
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).
This medicinal product contains sodium. It should be taken into consideration by patients on a controlled sodium diet.
4.5. Interaction 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.
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: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VedropTocofersolanum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Vedrop 50 mg/ml oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.