Prospect: information for the patient

Citicolina Faes 1000 mg oral solution EFG

Read this prospect thoroughly before starting to take this medication, as 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 or pharmacist.
• This medication has been prescribed only to 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 or pharmacist, even if they are not listed in this prospect. See section 4.

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

Citicolina Faes 1000 mg oral solution EFGis 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 takeCiticolina Faes 1000 mg oral solution EFG:

• If you are allergic to the active ingredient or to 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.

Children

Experience in children is limited, so it should only be administered if the expected therapeutic benefit outweighs any possible risk.

Other medications andCiticolina Faes 1000 mg oral solution EFG

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, including those purchased without a prescription.

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, a central nervous system stimulant.

Administration ofCiticolina Faes 1000 mg oral solution EFGwith food, beverages

This medication can be taken with meals or without them.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Citicolina Faes 1000 mg oral solution EFG contains sorbitol, cochineal red (Ponceau 4R), parahydroxybenzoates, and sodium

This medication contains sorbitol (E420). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Due to the presence of cochineal red (Ponceau 4R or E124), it may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains parahydroxybenzoates in the form of propyl esters (E217) and methyl esters (E218), which may cause allergic reactions (possibly delayed).

Patients with low-sodium diets should note that this medication contains 50.1 mg of sodium in each package.

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

The recommended dose is 500 mg to 2000 mg per day, depending on the severity of your illness. It can be taken directly from the package or dissolved in half a glass of water (120 ml).

If you take more Citicolina Faes 1000 mg oral solution EFG than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Citicolina Faes 1000 mg oral solution EFG

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citicolina Faes 1000 mg oral solution EFG

Do not discontinue treatment before consulting with 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 produce adverse effects, although not all people will experience them.

The adverse effects of this medication are very rare (less than 1 in 10,000 patients). It may appear 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.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications 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.

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

This medication does not require special conditions for conservation

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the Sigre point of the pharmacy. 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 Faes 1000 mg oral solution EFG composition

• The active ingredient is citicoline. 10 ml of citicoline solution contains 1000 mg of citicoline (as sodium salt).
• The other components are sodium saccharin (E954), sorbitol (E420), glycerin (E422), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E217), potassium sorbate (E-202), strawberry flavor, red Ponceau 4R color (E124), citric acid (E330), and purified water.

Product appearance and packaging contents

Citicolina Faes 1000 mg oral solution EFG is a clear, reddish-colored solution with strawberry flavor, presented in single-dose sachets.

Each package contains 10 or 30 sachets.

Only some package sizes may be commercially available.

Marketing authorization holder

FAES FARMA, S.A.

Máximo Aguirre, 14

48940 - Leioa

Responsible for manufacturing

FAES FARMA, S.A.

Máximo Aguirre, 14

48940 – Leioa

Spain

UNITHER LIQUID MANUFACTURING

1-3 Allée de la Neste, ZI d'En Sigal,

COLOMIERS, 31770

France

Last review date of this leaflet: October 2017