Vedrop

Patient Information Leaflet: Instructions for the User

Vedrop 50 mg/ml oral solution

Tocofersolan
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vedrop is and what it is used for
2. What you need to know before taking Vedrop
3. How to take Vedrop
4. Possible side effects
5. How to store Vedrop
6. Package contents 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 vitamin E deficiency due to gastrointestinal malabsorption (in which nutrients from food are not easily absorbed during digestion) in patients from birth (term neonates) up to 18 years of age who suffer from chronic cholestasis (an inherited or congenital disease in which bile cannot flow from the liver to the intestine).

2. What you need to know before taking 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 must not be used in premature infants.

Warnings and precautions
Talk to your doctor before taking Vedrop if you have:

• Kidney problems or dehydration. Vedrop should be used with caution and your kidney function must be closely monitored, as polyethylene glycol, which is part of the active substance tocophersolan, may damage the kidneys.
• Liver problems. Vedrop should be used with caution and your liver function must be closely monitored.

Other medicines and Vedrop
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking:

• Medicines to thin the blood (oral anticoagulants such as warfarin). Your doctor will ask you to have regular blood tests and adjust the dose to avoid the 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). Since Vedrop may increase their absorption during digestion, your doctor will need to monitor the treatment effect and adjust doses if necessary.

Pregnancy and breastfeeding
There are no clinical data available on exposure to this medicine during pregnancy. If you are pregnant, inform your doctor, who will decide whether you can take this medicine.
There are no data regarding the presence of this medicine in breast milk. If you intend to breastfeed, inform your doctor, who will decide on the best course of action for you and your baby.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Vedrop is unlikely to affect your ability to drive or operate machinery.

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

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 0.34 ml/kg/day.
Your doctor will prescribe the dose in ml.
Your doctor will adjust the dose based on your blood vitamin E levels.

Method of administration
Swallow the solution with or without water. Use only the oral syringe supplied in the package.
Vedrop may be taken before or during meals, with or without water.

To measure the dose:

1- Open the bottle.
2- Insert the oral syringe provided
into the bottle.

3- Draw up the liquid by pulling back
the plunger until the syringe is filled to the graduation mark corresponding to the amount 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 down:

• directly into the mouth, or
• into a glass of water, then drink all the contents of the glass.

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

If you take more Vedrop than you should
If you take high doses of vitamin E, temporary diarrhoea and stomach ache may occur. Consult your doctor or pharmacist if symptoms last more than two days.

If you forget to take Vedrop
Skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for the forgotten dose.

If you stop taking Vedrop
Do not stop treatment without consulting your doctor, as vitamin E deficiency may recur and cause health problems. Consult your doctor or pharmacist before stopping treatment.

If you have any questions about the use of this medicine, consult 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)

• Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)

• Asthenia (feeling of weakness)
• Headache
• Alopecia (hair loss)
• Itching
• Skin rash
• Abnormal blood sodium levels
• Abnormal blood potassium levels
• Increased transaminases (liver enzymes)

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

• Stomach ache

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex 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 carton and on the bottle after Exp.: The expiry date refers to the last day of the 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents 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, equivalent to 74.5 IU of tocopherol.
• The excipients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) (see the end of section 2 for further information on these two excipients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.

Description of the appearance of Vedrop and contents of the pack
Vedrop is a slightly viscous, pale yellow oral solution, supplied in a brown glass bottle closed with a child-resistant cap. Bottles contain 10 ml, 20 ml or 60 ml of oral solution. Each carton contains one bottle and an 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
Tour Hekla
52 avenue du Général de Gaulle
F-92800 Puteaux
France

Manufacturer
Recordati Rare Diseases
Tour Hekla
52 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien Lietuva
Recordati Recordati AB.
Tél/Tel: +32 2 46101 36 Tel: + 46 8 545 80 230
Švedija

България Luxembourg/Luxemburg
Recordati Rare Diseases Recordati
Teл.: +33 (0)1 47 73 64 58 Tél/Tel: +32 2 46101 36
France Belgique/Belgien

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

Danmark Malta
Recordati AB. Recordati Rare Diseases
Tlf: +46 8 545 80 230 Tel: +33 1 47 73 64 58
Sweden Malta

Deutschland Nederland
Recordati Rare Diseases Germany GmbH Recordati
Tel: +49 731 140 554 0 Tel: +32 2 46101 36
Belgium

Eesti Norge
Recordati AB. Recordati AB.
Tel: + 46 8 545 80 230 Tlf: +46 8 545 80 230
Sweden Sweden

Ελλάδα Österreich
Recordati Rare Diseases Recordati Rare Diseases Germany GmbH
Tel: +33 1 47 73 64 58 Tel: +49 731 140 554 0
France Germany

España Polska
Recordati Rare Diseases Spain S.L.U. Recordati Rare Diseases
Tel: + 34 91 659 28 90 Tel: +33 (0)1 47 73 64 58
Poland

France Portugal
Recordati Rare Diseases Recordati Rare Diseases SARL
Tél: +33 (0)1 47 73 64 58 Tel: +351 21 432 95 00

Hrvatska România
Recordati Rare Diseases Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58 Tel: +33 (0)1 47 73 64 58
Croatia Romania

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

Ísland Slovenská republika
Recordati AB. Recordati Rare Diseases
Tel: +46 8 545 80 230 Tel: +33 (0)1 47 73 64 58
Iceland France

Italia Suomi/Finland
Recordati Rare Diseases Italy Srl Recordati AB.
Tel: +39 02 487 87 173 Puh/Tel: +46 8 545 80 230
Sweden

Κύπρος Sverige
Recordati Rare Diseases Recordati AB.
Tel: +33 1 47 73 64 58 Tel: +46 8 545 80 230
France

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

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 about this medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually, and this package leaflet will be updated if necessary.
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu