Package Insert: Information for the Patient

CiticolinaTeva1000 mg Oral Solution EFG

Read this entire package insert carefully before starting to take this medication, because 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.

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

CiticolinaTevais 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 orby rupture of a blood vessel
• a head trauma, which is a blow to the head.

Do not take CiticolinaTeva

• if you are allergic to citicolina 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 Teva.

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

Children

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

Use of Citicolina Teva with other medications

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

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

Use of Citicolina Teva with food and beverages

Citicolina Teva 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 Teva, 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.

Citicolina Teva contains sorbitol

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Citicolina Teva contains cochineal red

It may cause allergic reactions.

Citicolina Teva contains parahydroxybenzoates

It may cause allergic reactions (possibly delayed).

Citicolina Teva contains formaldehyde

It may cause stomach discomfort and diarrhea.

Citicolina Teva contains sodium

This medication contains 83.83 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 4.19% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medication.If in 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 Citicolina Teva than you shouldTevathan 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 Citicolina TevaTeva

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

If you interrupt treatment with Citicolina TevaTeva

Your doctor will indicate the duration of your treatment with Citicolina Teva. Do not discontinue 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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use Website: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. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Citicolina CompositionTeva

• The active ingredient 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 formal, potassium sorbate (E-202), strawberry flavor,red Ponceau 4R color (E-124), citric acid(E-330) and purified water.

Appearance of the product and contents of the packaging

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

It is presented in a package containing 10 sachetsor 30 sachets in a multiple package(3 subunits of 10 sachets)with 10 ml of oral solution each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TevaPharma,S.L.U.

AnabelSegura11,BuildingAlbatrosB,1stfloor.

28108Alcobendas.Madrid.Spain

Responsible for manufacturing

STE PHARMA SYSTEMS, S.L.

Universitat Autònoma Avenue, 13

Parc Tecnològic del Vallès,

Cerdanyola del Vallès,

08290 Barcelona (Spain)

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50 Esplugues de Llobregat

08950 Barcelona (Spain)

Or

SAG Manufacturing SLU

Highway N-I, Km 36

28750 San Agustin de Guadalix, Madrid (Spain)

Or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna Street 66-70. Industrial Estate Urtinsa II.

Alcorcón

28923, Madrid (Spain)

Last review date of this leaflet:February 2014

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