CITICOLINE CINFAMED 1000 MG ORAL SOLUTION

Introduction

Patient Information Leaflet

CiticolinaCinfamed1000 mg oral solution EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Citicolina Cinfamed is and what it is used for
2. What you need to know before taking Citicolina Cinfamed
3. How to take Citicolina Cinfamed
4. Possible side effects
5. Storage of Citicolina Cinfamed
6. Package contents and additional information

1. What Citicolina Cinfamed is and what it is used for

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

Citicolina Cinfamed is used to treat memory and behavioral disorders due to:

• a stroke, which is an interruption of blood supply to the brain due to a clot or rupture of a blood vessel.

a head injury, which is a blow to the head.

2. What you need to know before taking Citicolina Cinfamed

Do not take CiticolinaCinfamed

• if you are allergic to the active ingredient citicolina or to any of the other components of this medication (listed in section 6).
• if you have parasympathetic nervous system hypertonia, which is a severe condition with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Citicolina Cinfamed

• 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 Citicolina Cinfamed with other medications

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

Citicolina enhances the effects of L-Dopa, so it should not be taken 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 taken in combination with medications containing meclofenoxate, which is a brain stimulant.

Taking Citicolina Cinfamed with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Citicolina Cinfamed contains sorbitol (E-420), cochineal red A (Ponceau 4R) (E-124), parahydroxybenzoates (E-216 and E-218), propylene glycol (E-1520), and sodium

This medication contains 78.76 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 3.85% of the maximum recommended daily sodium intake for an adult.

This medication contains 1.4 g of sorbitol (E-420) per sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

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

It may cause allergic reactions (possibly delayed) because it contains propylparaben (E-216) and methylparaben (E-218).

This medication contains 2.58 mg of propylene glycol (E-1520) per sachet.

3. How to take Citicolina Cinfamed

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

The recommended dose is 1 to 2 sachets per day, depending on the severity of your condition. To open the sachet correctly, it is recommended to cut it along the dotted line with scissors.

It can be taken directly or dissolved in half a glass of water (120 ml) with or without food.

If you take more Citicolina Cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Citicolina Cinfamed

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

If you stop treatment with Citicolina Cinfamed

Your doctor will indicate the duration of your treatment with Citicolina. Do not stop treatment before consulting your doctor.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

The side effects of this medication are very rare (may affect up to 1 in 10,000 patients). Headache, dizziness, nausea, occasional diarrhea, facial flushing, swelling of the limbs, and changes in blood pressure may occur. If you experience any of these or other symptoms, inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citicolina Cinfamed

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

Do not use this medication after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Citicolina Cinfamed composition

• The active ingredient is citicolina. Each sachet contains 1000 mg of citicolina (as sodium salt).
• The other components (excipients) are: sodium saccharin (E-954), non-crystallizable liquid sorbitol (E-420), glycerol (E-422), methylparaben (E-218), propylparaben (E-216), sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), cochineal red A (Ponceau 4R) (E-124), citric acid (E-330), and purified water.

Product appearance and packaging contents

Citicolina Cinfamed is a clear, pink-colored oral solution with a strawberry flavor and odor, packaged in sachets.

It is available in packaging containing 10 or 30 sachets, each with 10 ml of oral solution.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Galenicum Health, S.L.U

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix,

Madrid (Spain)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this leaflet: April 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80484/P_80484.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80484/P_80484.html