Citicoline Vir 1000 mg oral solution EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Citicolina Vir is and what it is used for
- 2. What you need to know before starting to take Citicolina Vir
- 3. How to take Citicoline Vir
- 4. Possible adverse effects
- 5. Storage of Citicoline Vir
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Citicolina Vir 1000 mg oral solution EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Citicolina Vir is and what it is used for
- What you need to know before taking Citicolina Vir
- How to take Citicolina Vir
- Possible adverse effects
- How to store Citicolina Vir
- Contents of the pack and other information
1. What Citicolina Vir is and what it is used for
Citicolina Vir belongs to a group of medicines called psychostimulants and nootropics, which work by improving brain function.
Citicolina Vir is used to treat memory and behavioral disturbances caused by:
- stroke, which is an interruption of blood supply to the brain due to a blood clot or rupture of a blood vessel.
- head trauma, which is a blow to the head.
2. What you need to know before starting to take Citicolina Vir
Do not take Citicolina Vir
- If you are allergic to citicoline or to any of the other ingredients of this medicine (listed in section 6).
- If you have parasympathetic nervous system hypertension, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Citicolina Vir
- if you are allergic to acetylsalicylic acid, as it may trigger asthma.
Children
Citicolina Vir has not been adequately studied in children, and therefore should only be administered if your doctor considers it necessary.
Taking Citicolina Vir with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Citicolina Vir enhances the effects of L-Dopa; therefore, it should not be administered simultaneously with medications containing L-Dopa without consulting your doctor. Medications containing L-Dopa are commonly used to treat Parkinson's disease.
Citicolina Vir should not be administered together with medications containing meclofenoxate, a cerebral stimulant.
Taking Citicolina Vir with food and drinks
Citicolina Vir can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Citicolina Vir, like most medicines, should not be administered during pregnancy, if you suspect you may be pregnant, or during breastfeeding, unless your doctor considers it necessary.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Citicolina Vir contains sorbitol, carmine red, parahydroxybenzoates, and sodium
This medicine contains sorbitol (E-420). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine may cause allergic reactions because it contains carmine red (Ponceau 4R or E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.
It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-217) and methyl parahydroxybenzoate (E-218).
Patients on low-sodium diets should be aware that this medicine contains 80.96 mg (3.52 mmol) of sodium per dose.
This medicine contains 80.96 mg of sodium (the main component of table/cooking salt) in each sachet. This corresponds to 4.05% of the maximum daily recommended sodium intake for an adult.
3. How to take Citicoline Vir
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 1 to 2 sachets per day, depending on the severity of your condition. It can be taken directly or dissolved in half a glass of water (120 ml), with or without food.
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tear the sachet along the arrows as indicated |
directly from the sachet or |
half a glass of water (120 ml) and drink it |
If you take more Citicolina Vir than you should
Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Citicolina Vir
Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Citicolina Vir
Your doctor will advise you on how long your treatment with Citicolina Vir should last. Do not discontinue the treatment without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects of this medicine are very rare (may affect up to 1 in 10,000 patients). These may include headache, dizziness, nausea, occasional diarrhoea, facial flushing, swelling of the extremities, and changes in blood pressure. If you experience any of these or other symptoms, inform your doctor.
Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Citicoline Vir
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Store in the original packaging.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Citicolina Vir
- The active substance is citicoline. Each sachet contains 1000 mg of citicoline (as the sodium salt).
- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420), glycerol (E-422), methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium citrate (E-331), glycerinformaldehyde, potassium sorbate (E-202), strawberry flavor, red color Ponceau 4R (E-124), citric acid (E-330), and purified water.
Appearance of the product and contents of the pack
Citicolina Vir is a pink, transparent oral solution with strawberry odor and flavor, packed in sachets.
It is presented in packs containing 10, 28, or 30 sachets in a single pack or in a multiple pack (3 subunits of 10 sachets) with 10 ml of oral solution each.
Marketing Authorization Holder and Manufacturer
Industria Química y Farmaceútica Vir S.A.
C/Laguna 66-70. Polígono Industrial Urtinsa II.
28923 Alcorcón (Madrid)
Date of the most recent review of this leaflet: December 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/