CITICOLINE KERN PHARMA 1000 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Citicolina Kern Pharma 1,000 mg Oral Solution EFG

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

• Keep this package 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Citicolina Kern Pharma is and what it is used for
2. What you need to know before taking Citicolina Kern Pharma
3. How to take Citicolina Kern Pharma
4. Possible side effects
5. Storage of Citicolina Kern Pharma
6. Contents of the pack and further information

1. What Citicolina Kern Pharma 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 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 Kern Pharma

Do not take Citicolina Kern Pharma

• 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 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.

Other Medications and Citicolina Kern Pharma

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 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 in combination with medications containing meclofenoxate, which is a brain stimulant medication.

Taking Citicolina Kern Pharma with Food and Drinks

This medication can be taken with meals or outside of meals.

Pregnancy and Breastfeeding

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 Using Machines

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

Citicolina Kern Pharma 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 3.94% of the maximum daily sodium intake recommended 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 disease 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 Kern Pharma

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 illness. It can be taken directly or dissolved in half a glass of water (120 ml) with meals or outside of meals.

If you take more Citicolina Kern Pharma 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 Kern Pharma

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

If you stop taking Citicolina Kern Pharma

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 cause side effects, although not everyone will experience 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citicolina Kern Pharma

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 medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Citicolina Kern Pharma

• The active ingredient is citicolina. Each sachet contains 1,000 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 formal, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), cochineal red A (Ponceau 4R) (E-124), anhydrous citric acid (E-330), and purified water.

Appearance of the product and packaging contents

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

It is presented in a packaging that contains 10 or 30 sachets in a multiple packaging (3 units of 10 sachets) with 10 ml of oral solution per sachet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona (Spain)

or

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix,

Madrid (Spain)

Date of the last revision of this package leaflet: March 2022

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/