Package Insert: Information for the Patient

CiticolinaSTADA1.000 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 doctororpharmacist.
• This medication has been prescribedonlyto 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 doctororpharmacist, evenifthey are not listed in this package insert. See section 4.

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

CiticolinaSTADAis 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 CiticolinaSTADA

• 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 or pharmacist before starting to take citicolina.

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

Children

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

Taking CiticolinaSTADAwith other medications

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

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

Taking CiticolinaSTADAwith food and drinks

Citicolina can be taken with meals or outside of 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, 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.

CiticolinaSTADAcontains sodium, sorbitol, propylparaben, methylparaben, and cochineal red

This medication contains 77 mg of sodium (main component of table salt) per tablet. This is equivalent to 3.85% of the maximum daily sodium intake recommended for an adult.

This medication contains 2 g of sorbitol per tablet.Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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.

It may cause allergic reactions (possibly delayed) because it contains propylparaben (E-217) and methylparaben (E-218).

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

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt, consult your doctor or pharmacist again.

The usual dose is 1 to 2 sachets 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 STADA than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Citicolina STADA

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 STADA

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

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

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

The adverse effects of this medication are very rare (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:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging.

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.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Citicolina STADA Composition

• The active ingredient is citicoline. Each sachet contains 1,000 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-217), sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), red Ponceau 4R color (E-124), citric acid (E-330), and purified water.

Appearance of the product and content of the container

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

It is presented in containers containing 10 or 30 sachets, each with 10 ml of oral solution. Some container sizes may only be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

Galenicum Health, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat

Barcelona (Spain)

or

SAG Manufacturing, S.L.U.

Crta N-I, Km 36

28750 San Agustín de Guadalix,

Madrid

Last review date of this leaflet: December 2013

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/