VEDROP 50 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Vedrop 50 mg/ml Oral Solution

Tocofersolan

This medicine is subject to additional monitoring, which 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 symptoms 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.

Contents of the Package Leaflet:

1. What is Vedrop and what is it used for
2. What you need to know before you take Vedrop
3. How to take Vedrop
4. Possible side effects
5. Storage of Vedrop
6. Contents of the pack and other information

1. What is Vedrop and what is it used for

Vedrop contains vitamin E (in the form of tocofersolan). This medicine is used to treat vitamin E deficiency caused by impaired digestive absorption (where nutrients from food are not easily absorbed during digestion) in patients from birth (term newborns) to 18 years of age with chronic cholestasis (a hereditary or congenital disease in which bile cannot pass 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 to any of the other ingredients of this medicine (listed in section 6).
• Vedrop should not be administered to premature babies.

Warnings and precautions

Consult your doctor before starting Vedrop if you have:

• Kidney problems or dehydration. Vedrop should be used with caution and kidney function should be carefully monitored, as the polyethylene glycol, which is part of the active ingredient tocofersolan, can damage the kidneys.
• Liver problems. Vedrop should be used with caution and liver function should be strictly monitored.

Taking Vedrop with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking:

• Certain medicines that reduce blood viscosity (oral anticoagulants such as warfarin). Your doctor will ask you to undergo regular blood tests and may adjust the dose to avoid a higher risk of bleeding.
• Fat-soluble vitamins (such as vitamins A, D, E, or K) or highly fat-soluble medicines (such as corticosteroids, cyclosporine, tacrolimus, antihistamines). Vedrop may increase their absorption during digestion, so the doctor will monitor the effect of the treatment and adjust the dose when necessary.

Pregnancy and breastfeeding

There are no clinical data available on the use of this medicine during pregnancy. Inform your doctor if you are pregnant so that he/she can decide whether to use the medicine.

There are no data on whether this medicine is excreted in breast milk. Inform your doctor if you want to breastfeed your child so that he/she can decide whether to use the medicine. Your doctor will help you make the best decision for you and your child.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It is unlikely that Vedrop will affect your ability to drive and use machines.

Vedrop contains methyl-parahydroxybenzoate sodium (E219) and ethyl-parahydroxybenzoate sodium (E215), which may cause allergic reactions (possibly delayed).

Vedrop contains 0.18 mmol (4.1 mg) of sodium per ml. Consult your doctor if you are on a low-sodium diet.

3. How to take Vedrop

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual dose is 0.34 ml/kg/day.

Your doctor will prescribe the dose in ml.

Your doctor will adjust the dose of this medicine according to your blood vitamin E levels.

Method of administration

Swallow the solution with or without water. Use it only with the oral syringe included in the package.

You can take Vedrop before or during meals, with or without water.

To measure the dose:

If you take more Vedrop than you should

If you take high doses of vitamin E, you may experience transient diarrhea and stomach pain. Consult your doctor or pharmacist if the symptoms persist for more than two days.

If you forget to take Vedrop

Do not take the missed dose and return to the regular scheduled administration. Do not take a double dose to make up for the missed doses.

If you stop taking Vedrop

Do not stop treatment without consulting your doctor, as it may cause a vitamin E deficiency that affects your health. Contact your doctor or pharmacist before stopping treatment.

If you have any other questions about the use of this product, 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 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
• Abnormal sodium levels in the blood
• Abnormal potassium levels in the blood
• Increased transaminases (liver enzymes)

Frequency not known(cannot be estimated from the available data)

• Stomach pain

Reporting of side effects

If you experience 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 through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 package and on the bottle after EXP. The expiry date is the last day of the month stated.
• This medicine does not require any special storage conditions.
• Discard the medicine one month after it has been opened, even if some solution remains.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vedrop

• The active substance is tocofersolan. Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, equivalent to 74.5 IU of tocopherol.
• The other ingredients are: potassium sorbate, methyl-parahydroxybenzoate sodium (E219) and ethyl-parahydroxybenzoate sodium (E215) (see the end of section 2 for more information on these two excipients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.

Appearance of Vedrop and pack contents

Vedrop is a pale yellow, slightly viscous oral solution contained in a brown glass bottle, sealed with a safety cap. The bottles contain 10 ml, 20 ml, or 60 ml of oral solution. Each pack 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

F-92800 Puteaux

France

Manufacturer

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

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

This medicine 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 medicine.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.