Prospect: information for the patient

CiticolinaTecniGen1000 mg oral solution EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people 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 prospect. See section 4.

1. What is Citicolina TecniGen and for what it is used

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

3. How to take Citicolina TecniGen

4. Possible adverse effects

5. Storage of Citicolina TecniGen

6. Contents of the package and additional information

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

CiticolinaTecniGenis 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 CiticolinaTecniGen

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takeCiticolinaTecniGen

- if you are allergic to acetylsalicylic acid, as it may cause asthma.

Children

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

Administration ofCiticolinaTecniGenwith other medications

Inform your doctor or pharmacist if you aretaking, have takenrecentlyor may have to take any other medication.

CiticolinaTecniGenpotentiates 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.

CiticolinaTecniGenshould not be administered concurrently with medications containing meclofenoxate, which is a central nervous system stimulant.

Administration of CiticolinaTecniGenwith food and beverages

CiticolinaTecniGencan be taken with meals or without them.

Pregnancy and lactation

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

CiticolinaTecniGen, 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 on the ability to drive and operate machinery have been observed.

CiticolinaTecniGencontains sorbitol, cochineal red, and parahydroxybenzoates

This medication contains sorbitol (E-420). If your doctor has indicated that you have a certain sugar intolerance, consult with him 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.

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

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

The usual 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 CiticolinaTecniGenthan 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 forgot to take CiticolinaTecniGen

Take your dose as soon as you remember. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with CiticolinaTecniGen

Your doctor will indicate the duration of your treatment with CiticolinaTecniGen. Do not stop treatment before 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 unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of CytidineTecniGen

- The active ingredient is cytidine. Each sachet contains 1000 mg of cytidine (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-217), sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor, red Ponceau 4R color (E-124), citric acid (E-330), and purified water.

Appearance of the product and content of the container

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

It is presented in a container that contains 10 sachets with 10 ml of oral solution each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid) Spain.

Responsible for manufacturing

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix,

Madrid(Spain)

Last review date of this leaflet: December 2015

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