Citicolina vir 1000 mg solucion oral efg

Package Insert: Information for the Patient

Citicolina Vir 1000 mg Oral Solution EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Citicolina Vir and how is it used

2. What you need to know before starting to take Citicolina Vir

3. How to take Citicolina Vir

4. Possible adverse effects

5. Storage of Citicolina Vir

6. Contents of the package and additional information

CiticolinaVirbelongs to a group of medications called psychostimulants and nootropics, which act by improving brain function.

CiticolinaViris used for the treatment of memory and behavior alterations due to:

• a stroke, which is an interruption of blood supply to the brain by a clot or rupture of a blood vessel.
• a head trauma, which is a blow to the head.

Do not take Citicolina Vir

• If you are allergic to citicoline or any of the other components of this medication (listed in section 6).
• If you have autonomic nervous system hypertension, a serious condition with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Citicolina Vir.

• If you are allergic to acetylsalicylic acid, as it may cause asthma.

Children

Citicolina Vir has not been adequately studied in children, so it should only be administered if your doctor considers it necessary.

Taking Citicolina Vir with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Citicolina Vir potentiates the effects of L-Dopa, so it should not be administered at the same time as medications containing L-Dopa, without consulting your doctor. Medications containing L-Dopa are usually used to treat Parkinson's disease.

Citicolina Vir should not be administered concurrently with medications containing meclofenoxate, a central nervous system stimulant.

Taking Citicolina Vir with food and beverages

Citicolina Vir can be taken with meals or without them.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Citicolina Vir, like most medications, should not be administered if you are pregnant, think you may be pregnant, or during breastfeeding, unless your doctor considers it necessary.

Driving and operating machinery

No effects have been observed on the ability to drive and use machinery.

Citicolina Vir contains sorbitol, cochineal red, parahydroxybenzoates, and sodium

This medication contains sorbitol (E-420). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains cochineal red (Ponceau 4R or E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-217) and methyl parahydroxybenzoate (E-218).

Patients on low-sodium diets should note that this medication contains 80.96 mg (3.52 mmol) of sodium per dose.

This medication contains 80.96 mg of sodium (main component of table salt/for cooking) in each packet. This is equivalent to 4.05% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The normal dose is 1 to 2 packets per day, depending on the severity of your illness. It can be taken directly or dissolved in half a glass of water (120 ml) with meals or without them.

If you take more Citicolina Vir than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 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 compensate for the missed doses.

If you interrupt treatment with Citicolina Vir

Your doctor will indicate the duration of your treatment with Citicolina Vir. Do not discontinue treatment without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

The adverse effects of this medication are very rare (they may affect up to 1 in 10,000 patients). It may cause headache, dizziness, nausea, occasional diarrhea, facial flushing, swelling of the extremities, and changes in blood pressure. If you experience any of these or other symptoms, inform your doctor.

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 theSpanish System for Pharmacovigilance of Medicinal Products for Human UseWebsite:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Store in the original packaging.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Citicolina Vir Composition

- The active principle is citicoline. Each sachet contains 1000 mg of citicoline (as sodium salt).

- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420), glycerol (E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry essence, red Ponceau 4R color (E-124), citric acid (E-330), and purified water.

Appearance of the product and contents of the packaging

Citicolina Vir is a transparent oral solution of pink color, with a strawberry smell and taste, packaged in sachets.

It is presented in a packaging containing 10 or 30 sachets in standard packaging or in a multiple packaging (3 subunits of 10 sachets) with 10 ml of oral solution in each sachet.

Holder of the marketing authorization and responsible for manufacturing

Industria Química y Farmaceútica Vir S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcon (Madrid)

Last review date of this leaflet: December 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/