Vedrop 50 mg/ml oral solution

Vedrop contains vitamin E (in the form of tocofersolan). It is used to treat vitamin E deficiencies due to digestive malabsorption in children and adolescents suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine).

Do not takeVedrop
If you are allergic (hypersensitive) to vitamin E (d-alpha-tocopherol) or to any of the other ingredients of Vedrop (see section 6 ?What Vedrop contains-).

Take special care with Vedrop

You should tell your doctor 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. When taking Vedrop, your doctor will perform regular tests to check the function of your kidneys.
-Problems with your liver. Vedrop should be used with caution and liver functions closely monitored.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

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 enhance their intestinal absorption, your doctor will monitor the treatment effect and adjust the doses if necessary.

Taking Vedrop with food and drink

You can take Vedrop before or during your meal, with or wihout water.

Pregnancy and breast-feeding

No clinical data are available on exposure to this medicine during pregnancy. Please 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. Please inform your doctor if you want to breast-feed and he/she will decide if the medicine may be used.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Vedrop

This medicine contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium- free-. It also contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ?potassium- free-.

Always take Vedrop exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For chronic cholestasis, the usual dose is 0.34 ml/kg/day.
The dose will be adjusted by your doctor according to your vitamin E blood level.

Method of administration
Vedrop should be swallowed with or without water. It should be used only with the oral syringe provided in the box.

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 abdominal pain.

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Vedrop can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.

The following side effects were reported:

Common side effects

Diarrhoea

Uncommon side effects
Fatigue (feeling of weakness)
Headache
Loss of hair
Itching
Rash (eruption on the skin)
Abnormal level of sodium in the bloodAbnormal level of potassium in the blood

Increase of transaminases liver enzymes

If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children. Do not use Vedrop 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. Keep the bottle tightly closed. Discard the bottle one month after first opening, 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. These measures will help to protect the environment.

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), sodium propyl parahydroxybenzoate (E217), 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. 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 and Manufacturer

Orphan Europe S.A.R.L.
Immeuble ?Le Wilson?
70 avenue du General de Gaulle
92800 Puteaux
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Orphan Europe Benelux Koning Albert I, Iaan 48 bus 3 B-1780 Wemmel TélTel 32 2 46101 36 LuxembourgLuxemburg Orphan Europe Benelux Koning Albert I, Iaan 48 bus 3 B-1780 Wemmel BelgiqueBelgiëBelgien TélTel 32 2 46101 36

Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Te. 49 6074 914090 Magyarország Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Németország Tel 49 6074 914090

eská republika Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nmecko Tel 49 6074 914090 Malta Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F-92800 Puteaux Franza Tel 33 1 47 73 64 58

Danmark Orphan Europe AB Banérgatan 37 S-115 22 Stockholm vedija Tel 46 8 545 80 230 Nederland Orphan Europe Benelux Koning Albert I Iaan 48 bus 3 B-1780 Wemmel België Tel 32 2 46101 36

Deutschland Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Tel 49 06074 914090 Norge Orphan Europe AB Banérgatan 37 S-115 22 Stockholm vedija Tel 46 8 545 80 230

Eesti Orphan Europe AB Banérgatan 37 S-115 22 Stockholm Rootsi Tel 46 8 545 80 230 Österreich Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Deutschland Tel 49 6074 914090

Polska Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Niemcy Tel 49 6074 914090 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F-92800 Puteaux 33 1 47 73 64 58

España Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho, n1 E-08010 Barcelona Tel 34 93 342 51 20 Portugal Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho, n1 E-08010 Barcelona Espanha Tel 34 93 342 51 20

France Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F-92800 Puteaux Tél 33 1 47 73 64 58 România Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Germania Tel 49 6074 914090

Slovenija Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemija Tel 49 6074 914090 Ireland Orphan Europe UK Ltd. Isis House, 43 Station Road Henley-on-Thames Oxfordshire RG9 1AT, UK United Kingdom Tel 44 1491 414333

Ísland Orphan Europe AB Banérgatan 37 S-115 22 Stockholm vedija Tel 46 8 545 80 230 Slovenská republika Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemecko Tel 49 6074 914090

Italia Orphan Europe Italy Srl Via Cellini 11 I-20090 Segrate Milano Tel 39 02 26 95 01 39 SuomiFinland Orphan Europe AB Banérgatan 37 S-115 22 Stockholm Ruotsi Tel 46 8 545 80 230

Sverige Orphan Europe AB Banérgatan 37 S-115 22 Stockholm Tel 46 8 545 80 230 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F-92800 Puteaux 33 1 47 73 64 58

Latvija Orphan Europe AB Banérgatan 37 S-115 22 Stockholm Zviedrija Tel 46 8 545 80 230 United Kingdom Orphan Europe UK Ltd. Isis House, 43 Station Road Henley-on-Thames Oxfordshire RG9 1AT Tel 44 1491 414333

Lietuva

Orphan Europe AB
Banérgatan 37
S-115 22 Stockholm
?vedija
Tel: +46 8 545 80 230

This leaflet was last approved 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 (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.