Vedrop 50 mg/ml en solucion oral
Introduction
Label: information for the user
Vedrop 50 mg/ml oral solution
Tocofersolán
This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.
Read this label carefully before starting to take this medicine, as it contains important information for you.
- Keep this label, as you may need to refer to it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
1. What is Vedrop and what is it used for
Vedrop contains vitamin E (in the form of tocophersolan). This medication is used to treat vitamin E deficiency caused by digestive malabsorption (in which nutrients from food are not easily absorbed during digestion) in patients aged from birth (full-term newborns) to 18 years 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 starting to take Vedrop
Do not take Vedrop
- If you are allergic to vitamin E (d-alfa tocopherol or any of the other components of this medication (listed in section 6).
- Vedrop should not be administered to premature babies.
Warnings and precautions
Consult your doctor before starting to take Vedrop if you have:
- Kidney problems or dehydration. Vedrop should be used with caution and renal function should be closely monitored, as polyethylene glycol, part of the active ingredient tocopherol, may damage the kidneys.
- Liver problems. Vedrop should be used with caution and liver function should be strictly monitored.
Taking Vedrop with other medications
Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.
Inform your doctor or pharmacist if you are taking:
- Certain medications that thin the blood (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 medications (such as corticosteroids, ciclosporin, tacrolimus, antihistamines). Vedrop may increase their absorption during digestion, so your doctor will monitor the treatment effect and adjust the dose as needed.
Pregnancy and breastfeeding
No clinical data are available on the use of this medication during pregnancy. Inform your doctor if you are pregnant so that they can decide whether it is advisable to use the medication.
No data are available on whether this medication is excreted in breast milk. Inform your doctor if you wish to breastfeed so that they can decide whether it is advisable to use the medication. Your doctor will help you make the best decision for you and your child.
Consult your doctor or pharmacist before taking any medication.
Driving and operating machines
It is unlikely that Vedrop will affect your ability to drive and operate machines.
Vedrop contains sodium metisulfite (E219) and ethyl parahydroxybenzoate (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 follow a low-sodium diet.
3. How to Take Vedrop
Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 medication according to your blood vitamin E levels.
Administration Form
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:
1- Open the bottle. 2- Insert the oral syringe into the bottle. | ||
3- Fill the oral syringe with the liquid by pulling the plunger until it reaches the reference mark corresponding to the amount in milliliters (ml) prescribed by your doctor. | ||
4- Remove the oral syringe from the bottle. 5- Empty the syringe contents by pressing the plunger to the bottom either: - directly into the mouth, or - pour it into a glass of water and then drink the contents. | ||
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, you may experience transient diarrhea and stomach pain. Consult your doctor or pharmacist if symptoms persist for more than two days.
If you forget to take Vedrop
Do not take the missed dose and return to the regular administration schedule. Do not take a double dose to compensate for the missed dose.
If you interrupt treatment with Vedrop
Do not stop treatment without consulting your doctor, as a deficiency in vitamin E may recur, affecting 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 Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people will experience them.
The following adverse effects have been reported:
Frequent Adverse Effects (may affect up to 1 in 10 people)
- Diarrea
Possible Adverse Effects (may affect up to 1 in 100 people)
- Astenia (sensation of weakness)
- Cephalalgia
- Hair loss
- Itching
- Dermatological eruption
- Abnormal sodium levels in blood
- Abnormal potassium levels in blood
- Increased transaminases (liver enzymes)
Unknown Frequency(cannot be estimated from available data)
- Abdominal pain
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAnnex V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Vedrop Conservation
- Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the packaging and on the bottle after EXP. The expiration date is the last day of the month indicated.
- This medication does not require special conservation conditions.
- Dispose of the medication one month after it has been opened, even if some solution remains.
Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Vedrop
- The active principle is tocofersolan. Each milliliter of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, equivalent to 74.5 UI of tocopherol.
- The other components 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 dodecahydrate phosphate, concentrated hydrochloric acid, ultrapure water.
Appearance of Vedrop and contents of the package
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 package contains a 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 Authorization Holder
Recordati Rare Diseases
Immeuble “Le Wilson”
70, avenue du General de Gaulle
F-92800 Puteaux
France
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 request more information about this medication by contacting the local representative of the marketing authorization holder.
Belgium/België/Belgien Recordati Tel/Tel: +32 2 46101 36 | Lithuania Recordati AB. Tel: + 46 8 545 80 230 Sweden |
... Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 ... | Luxembourg/Luxemburg Recordati Tel/Tel: +32 2 46101 36 Belgium/Belgien |
Czech Republic Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France | Hungary RecordatiRare Diseases Phone: +33 (0)1 47 73 64 58 France |
Denmark Recordati AB. Tlf : +46 8 545 80 230 Sweden | Malta Recordati Rare Diseases Phone: +33 1 47 73 64 58 France |
Germany Recordati Rare Diseases Germany GmbH Phone: +49 731 140 554 0 | Netherlands Recordati Phone: +32 2 46101 36 Belgium |
Estonia Recordati AB. Tel: + 46 8 545 80 230 Sweden | Norway Recordati AB. Tlf : +46 8 545 80 230 Sweden |
Greece Recordati Rare Diseases Phone: +33 1 47 73 64 58 France | Austria Recordati Rare Diseases Germany GmbH Phone: +49 731 140 554 0 Germany |
Spain Recordati Rare Diseases Spain S.L.U. Phone: + 34 91 659 28 90 | Poland Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France |
France Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 | Portugal Jaba Recordati S.A. Phone: +351 21 432 95 00 |
Croatia Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France | Romania Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France |
Ireland Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France | Slovenia Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France |
Iceland Recordati AB. Simi:+46 8 545 80 230 Sweden | Slovakia Recordati Rare Diseases Phone: +33 (0)1 47 73 64 58 France |
Italy Recordati Rare Diseases Italy Srl Phone: +39 02 487 87 173 | Finland/Suomi Recordati AB. Puh/Tel : +46 8 545 80 230 Sweden |
Cyprus Recordati Rare Diseases Phone: +33 1 47 73 64 58 France | Sweden Recordati AB. Phone: +46 8 545 80 230 |
Lithuania Recordati AB. Phone: + 46 8 545 80 230 Sweden | United Kingdom Recordati Rare Diseases UK Ltd. Phone: +44 (0)1491 414333 |
Last review date of this leaflet:
This medicine has been authorized under "exceptional circumstances". This type of authorization means that, due to the rarity of your disease, it has not been possible to obtain complete information about this medicine.
The European Medicines Agency will review any new information available for this medicine annually and this leaflet will be updated as necessary.
More detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu/.
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