Citicoline Faes 1000 mg oral solution EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Citicoline Faes 1000 mg oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

1. What Citicolina Faes 1000 mg oral solution EFG is and what it is used for

Citicoline belongs to a group of medicines called psycho stimulants and nootropics, which work by improving brain function.

Citicolina Faes 1000 mg oral solution EFG is used to treat memory and behavioural disturbances due to:

• a stroke, which is an interruption of blood supply to the brain caused by a blood clot or rupture of a blood vessel.
• a head injury, which is a blow to the head.

2. What you need to know before starting to take Citicoline Faes 1000 mg oral solution EFG

Do not take Citicoline Faes 1000 mg oral solution EFG:

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• If you have parasympathetic nervous system hypertonia, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.

Children

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

Other medicines and Citicoline Faes 1000 mg oral solution EFG

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Citicoline enhances the effects of L-Dopa; therefore, it should not be administered concomitantly with medicines containing L-Dopa without consulting your doctor. Medicines containing L-Dopa are commonly used to treat Parkinson's disease.

Citicoline should not be administered together with medicines containing meclofenoxate, a central nervous system stimulant.

Taking Citicoline Faes 1000 mg oral solution EFG with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

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

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

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

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

Patients on low-sodium diets should be aware that this medicine contains 50.1 mg of sodium per sachet.

3. How to take Citicolina Faes 1000 mg oral solution EFG

Follow exactly the instructions for administration of this medicine provided 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 condition. It can be taken directly from the sachet or dissolved in half a glass of water (120 ml).

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

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount used.

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Citicolina Faes 1000 mg oral solution EFG

Do not discontinue treatment before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects of this medicine are very rare (less than 1 in 10,000 patients). These may include headache, dizziness, nausea, occasional diarrhoea, 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 experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citicoline Faes 1000 mg oral solution EFG

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citicoline Faes 1000 mg oral solution EFG

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

Appearance of the product and contents of the container

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

Each pack contains 10 or 30 sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

UNITHER LIQUID MANUFACTURING

1-3 Allée de la Neste, ZI d'En Sigal,

COLOMIERS, 31770

France

Date of the most recent revision of this leaflet: September 2025