50 mg/ml oral solution
Tocofersolan
What Vedrop is and what it is used for
Vedrop contains vitamin E (in the form of tocopherol). It is used to treat vitamin E deficiency due to malabsorption (where nutrients in the stomach are not easily absorbed when food is digested) in patients from birth (full-term newborns) to age 18 with chronic cholestasis (an inherited or congenital disease in which bile cannot be transported from the liver to the intestine).
What you need to know before taking 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:
- kidney problems or suffer from dehydration. Vedrop should only be used with caution and your kidney function should be closely monitored because polyethylene glycol, part of the active substance tocopherol, can damage your kidneys.
- problems with the liver. Vedrop should only be used with caution and liver function should be closely monitored.
Other medicines and Vedrop
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Tell your doctor and pharmacist if you are taking:
- certain medicines for thinning the blood (oral anticoagulants such as warfarin ). A doctor will then take regular blood tests and may adjust the dose to avoid a higher risk of bleeding.
- fat-soluble vitamins (eg A, D, E, or K) or significantly fat-soluble drugs (eg corticoids, cyclosporine, tacrolimus, or antihistamines ). As Vedrop can increase absorption during digestion, the doctor will monitor the treatment effect and adjust the doses if necessary.
Pregnancy and breastfeeding
No clinical data are available on exposure to this drug during pregnancy. Inform the doctor if you are pregnant so that he/she can decide if the medicine can be used.
There is no information on whether this drug is excreted in breast milk. Inform the doctor if you want to breastfeed. He/she will help you decide what is best for you and your child.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Vedrop is unlikely to affect your ability to drive and use machines.
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215)
which can cause an allergic reaction (possibly delayed).
Vedrop contains 0.18 mmol (4.1 mg) sodium per ml. Talk to your doctor if you are on a sodium-restricted diet.
How to take Vedrop
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual dose is 0.34 ml/kg/day.
The doctor will prescribe a dose of one in ml.
The dose will be adjusted by the doctor according to the level of vitamin E in your blood.
Mode of administration
Swallow the solution with or without water. It should only be used with the oral syringe provided in the package.
You can take Vedrop before or after a meal, with or without water.
Measurement of the dose:
If you have taken too much Vedrop
If you take large doses of vitamin E, you may experience temporary diarrhea and stomach pain. Talk to your doctor or pharmacist if symptoms persist for more than two days.
If you forget to take Vedrop
Skip the missed dose and return to the normal dosage. Do not take a double dose to make up for a missed dose.
If you stop taking Vedrop
Do not stop treatment without consulting a doctor as vitamin E deficiency may return and affect your health. Consult a doctor or pharmacist before stopping.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common side effects ( may affect up to 1 in 10 people)
- Diarrhea
Uncommon side effects ( may affect up to 1 in 100 people)
- Asthenia (feeling of weakness)
- Headache
- Hair loss
- Itching
- Rash (skin reactions)
- Abnormal level of sodium in the blood
- Abnormal level of potassium in the blood
- Increase in transaminases (liver enzymes)
Frequency not known (cannot be estimated from available data)
- Stomach ache
How Vedrop should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.
- This medicine does not need special storage instructions.
- Discard the bottle one month after the first opening, even if there is a solution left in the bottle.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tocopherol. Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocopherol, which corresponds to 74.5 IU of tocopherol.
- The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see the end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid and purified water.
Appearance and package sizes of the medicine
Vedrop is a slightly viscous and pale yellow oral solution in a brown glass bottle that is closed with a child-resistant screw cap. The bottles contain 10 ml, 20 ml, or 60 ml of oral solution. Each carton contains a vial and a syringe for oral use (a 1 mL syringe with a 10 mL or 20 mL vial, and a 2 mL syringe with a 60 mL vial).
Marketing Authorisation Holder
Recordati Rare Diseases
Building “Le Wilson”
70, avenue du General de Gaulle
F-92800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Building “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Park
30, rue des Peupliers
F-92000 Nanterre
France
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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