Инструкция по применению VEDROP
Содержание инструкции
Vedrop 50 mg/ml oral solution
Tocofersolan
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
information on safety. You can contribute by reporting any adverse effects encountered
during the use of this medicine. See the end of section 4 for information on how
to report adverse effects.
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell 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 you take Vedrop
- 3. How to take Vedrop
- 4. Possible side effects
- 5. How to store Vedrop
- 6. Contents of the pack and other information
1. What Vedrop is and what it is used for
Vedrop contains vitamin E (in the form of tocopherol succinate). It is used to treat vitamin E deficiency
due to digestive malabsorption (where nutrients from food are not easily absorbed
during digestion) in patients from birth (full-term infants) 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 experience:
- Kidney problems or dehydration. Vedrop must be used with caution and your kidney function must be closely monitored, as polyethylene glycol, which is part of the active ingredient tocophersolan, can damage the kidneys.
- Liver problems. Vedrop must be used with caution and the liver 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 medicine.
Tell your doctor or pharmacist if you are taking:
- Medicines to thin the blood (oral anticoagulants such as warfarin). Your doctor may ask you to have regular blood tests adjusting the dose to avoid the risk of bleeding.
- Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticosteroids, cyclosporine, tacrolimus, antihistamines). Because Vedrop can increase their absorption during digestion, your doctor will need to check the effect of the treatment and adjust the doses, if necessary.
Pregnancy and breastfeeding
No clinical data are available on exposure to this medicine during pregnancy. If you are
pregnant, inform your doctor, who will decide whether you can take the medicine.
There are no data regarding the possible presence in breast milk. If you wish to breastfeed, inform your doctor,
who will decide the best solution for you and your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Vedrop is unlikely 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 (including delayed reactions).
Vedrop contains 0.18 mmol (4.1 mg) of sodium per ml. Talk to your doctor if you are on a
low-sodium diet.
3. How to take Vedrop
Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.
The normal dose is 0.34 ml/kg/day.
The doctor will prescribe the dose in ml.
The doctor will adjust the dose based on your blood vitamin E level.
Method of administration
Swallow the solution with or without water. Use only with the oral syringe supplied in the box.
Vedrop can be taken before or during meals, with or without water.
To measure the dose:
- 1- Open the bottle.
- 2- Insert the oral syringe included in the package into the bottle.

- 3- Fill the oral syringe with the liquid by pulling the plunger up to the graduation mark corresponding to the amount in milliliters (ml) prescribed by the doctor.

- 4- Remove the oral syringe from the bottle.
- 5- Empty the contents of the syringe by pushing the plunger to the bottom:

- directly into the mouth, or
- into a glass of water, then drink the entire contents of the glass.
- 6- Close the bottle.
- 7- Wash the syringe with water.

If you take more Vedrop than you should
If you take high doses of Vitamin E, temporary diarrhea and stomach upset may occur. Contact your
doctor or pharmacist if the symptoms last more than two days.
If you forget to take Vedrop
Skip the missed dose and return to your normal dosing schedule. Do not take a double dose to make up for a
missed dose.
If you stop taking Vedrop
Do not stop treatment without consulting your doctor, as vitamin E deficiency may recur and
cause health problems. Before stopping, consult your doctor or pharmacist.
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 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 levels of sodium in the blood
- Abnormal levels of potassium in the blood
- Increased transaminases (liver enzymes)
Not known(frequency cannot be estimated from available data)
- Stomach pain
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Appendix 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 that is reported on the package and the bottle after Exp: The expiry date refers to the last day of the month.
- This medicine does not require any particular storage conditions.
- Dispose of the bottle one month after first opening, even if some solution remains.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Vedrop contains
- The active substance is tocopherolsolan. Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocopherolsolan, corresponding to 74.5 IU of tocopherol.
- The excipients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see the end of paragraph 2 for further information on these 2 excipients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.
Description of the appearance of Vedrop and contents of the pack
Vedrop is an oral solution, slightly viscous and light yellow in color, in a brown glass bottle
closed with a child-resistant cap. The bottles contain 10 ml, 20 ml or 60 ml of oral solution. Each
pack contains one bottle and a syringe for oral use (one 1 ml syringe with a 10 ml or 20 ml bottle,
one 2 ml syringe with a 60 ml bottle).
Marketing Authorisation Holder
Recordati Rare Diseases
Immeuble “le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Immeuble “Le Wilson”
70, 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 on this medicinal product, contact the local representative of the marketing
authorisation holder
Belgique/België/Belgien
Recordati
Tél/Tel: +32 2 46101 36
Lietuva
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
България
Recordati Rare Diseases
Тел.: +33 (0)1 47 73 64 58
France
Luxembourg/Luxemburg
Recordati
Tél/Tel: +32 2 46101 36
Belgique/Belgien
Česká republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Magyarország
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Danmark
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Malta
Recordati Rare Diseases
Tel: +33 1 47 73 64 58
France
Deutschland
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Nederland
Recordati
Tel: +32 2 46101 36
België
Eesti
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
Norge
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Ελλάδα
Recordati Rare Diseases
Τηλ: +33 1 47 73 64 58
France
Österreich
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Germany
España
Recordati Rare Diseases Spain S.L.U.
Tel: + 34 91 659 28 90
Polska
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
France
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
Portugal
Jaba Recordati S.A.
Tel: +351 21 432 95 00
Hrvatska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France
România
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ireland
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Slovenija
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ísland
Recordati AB.
Simi:+46 8 545 80 230
Sweden
Slovenská republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Italia
Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173
Suomi/Finland
Recordati AB.
Puh/Tel : +46 8 545 80 230
Sweden
Κύπρος
Recordati Rare Diseases
Τηλ : +33 1 47 73 64 58
France
Sverige
Recordati AB.
Tel : +46 8 545 80 230
Latvija
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
United Kingdom
Recordati Rare Diseases UK Ltd.
Tel: +44 (0)1491 414333
An authorisation for this medicinal product has been granted in “exceptional circumstances”. This means that
because of the rarity of its disease it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information on this
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .
- Страна регистрации
- Форма выпускаOral solution, 50 MG/ML
- Код АТХA11HA08
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги VEDROPФорма выпуска: Soft capsule, 400 U.I.Действующее вещество: Токоферол (витамин Е)Производитель: ABIOGEN PHARMA S.P.A.Отпускается без рецептаФорма выпуска: Enteric-coated tablet, 300 MGДействующее вещество: pyridoxine (vit B6)Производитель: TEOFARMA S.R.L.Отпускается без рецептаФорма выпуска: Injectable solution, 500 MG/2 MLДействующее вещество: ДекспантенолПроизводитель: BAYER S.P.A.Отпускается по рецепту
Аналоги VEDROP в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог VEDROP в Испания
Врачи онлайн по VEDROP
Обсудите применение VEDROP и возможные следующие шаги — по оценке врача.
Получите рецепт на VEDROP онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
VEDROP требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество VEDROP — Токоферсолан. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
VEDROP производится компанией RECORDATI RARE DISEASES SARL. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения VEDROP с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить VEDROP в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Токоферсолан) включают ARMILLA, BENADON, BEPAMEDIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















