Package Insert: Information for the Patient

Citicolinaratiopharm1.000 mg oral solution EFG

Read this 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 prescribedonlyfor you, and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist, or nurse, evenifthey are not listed in this package insert. See section 4.

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

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

• a cerebrovascular accident, 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 Citicolinaratiopharm

• 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 severe condition with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

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

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

Children

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

Administration ofCiticolinaratiopharmwith other medications

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

Citicolinaratiopharmpotentiates 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.

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

Administration of Citicolinaratiopharmwith food and beverages

Citicolinaratiopharmcan 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.

Citicolinaratiopharm, 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.

Citicolinaratiopharmcontains sorbitol

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or they) 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 ratiopharm contains cochineal red

It may cause allergic reactions.

Citicolina ratiopharm contains parahydroxybenzoates

It may cause allergic reactions (possibly delayed).

Citicolinaratiopharmcontains formaldehyde

It may cause stomach discomfort and diarrhea.

Citicolinaratiopharmcontains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.This includes consulting your doctor or pharmacist again if you are unsure.

The normal dose is 1 to 2 packets 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 meals or without them.

If you take more Citicolina ratiopharm 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 forgot to take Citicolina ratiopharm

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

If you interrupt treatment with Citicolina ratiopharm

Your doctor will inform you of the duration of your treatment with Citicolina ratiopharm. 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 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 medicine 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. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Citicolina Compositionratiopharm

• The active ingredient is citicoline. Each packet 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 package

Citicolinaratiopharmis a transparent oral solution of pink color, with a strawberry smell and taste packaged in a packet.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid, Spain

Responsible for manufacturing

STE PHARMA SYSTEMS, S.L.

Avda. Universitat Autònoma, 13

Parc Tecnològic del Vallès,

Cerdanyola del Vallès,

08290 Barcelona (Spain)

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50Esplugues de Llobregat

08950 Barcelona (Spain)

Or

SAGManufacturing,SLU

Highway N-I,Km36

28750SanAgustindeGuadalix.Madrid(Spain)

Or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 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/