CITICOLINE TEVAGEN 1000 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

CiticolinaTevagen1,000 mg Oral Solution EFG

Read the entire 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 or pharmacist.
• 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Citicolina Tevagen and what is it used for
2. What you need to know before taking Citicolina Tevagen
3. How to take Citicolina Tevagen
4. Possible side effects
5. Storage of Citicolina Tevagen

1. Package Contents and Additional Information

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

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

Citicolina Tevagen 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 Tevagen

Do not take CiticolinaTevagen

• if you are allergic to citicolina or 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 or pharmacist before starting to take Citicolina

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

Children

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

Other Medications and CiticolinaTevagen

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 commonly used to treat Parkinson's disease.

Citicolina should not be administered in combination with medications containing meclofenoxate, which is a brain stimulant medication.

Taking CiticolinaTevagenwith Food

Citicolina Tevagen can be taken with or without food.

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.

Citicolina Tevagen should not be administered if you are pregnant or breastfeeding, unless your doctor considers it necessary.

Driving and Using Machines

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

Citicolina Tevagen contains Red Ponceau 4R (E-124)

It may cause allergic reactions.

CiticolinaTevagencontains Sorbitol (E-420)

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.

Citicolina Tevagen contains Parahydroxybenzoates

This medication contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218). It may cause allergic reactions (possibly delayed).

Citicolina Tevagen contains Sodium

This medication contains 80.8 mg of sodium (main component of table/cooking salt) per 10 ml sachet. This is equivalent to 4% of the maximum recommended daily sodium intake for an adult.

3. How to take Citicolina Tevagen

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

The normal 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 or without food.

If you take more CiticolinaTevagenthan you should

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

If you forget to take CiticolinaTevagen

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

If you interrupt treatment with CiticolinaTevagen

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

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

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 people). Hallucinations, headache, dizziness, difficulty breathing, nausea, vomiting, occasional diarrhea, flushing of the face, hives, skin rash, purple spots on the skin, chills, 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 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 Tevagen

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

Do not use this medication after the expiration date shown 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

Composition of CiticolinaTevagen

• The active ingredient is citicolina. Each sachet contains 1,000 mg of citicolina (as sodium salt).
• The other components (excipients) are: sodium saccharin (see section 2 "Citicolina Tevagen contains sodium"), non-crystallizable liquid sorbitol (E-420) (see section 2 "Citicolina Tevagen contains sorbitol (E-420)"), glycerol (E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) (see section 2 "Citicolina Tevagen contains parahydroxybenzoates"), sodium citrate, formal glycerol, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), Red Ponceau 4R color (E-124) (see section 2 "Citicolina Tevagen contains Red Ponceau 4R (E-124)"), citric acid, and purified water.

Appearance of the Product and Package Contents

Citicolina Tevagen is a clear, pink-colored oral solution with a strawberry flavor and odor. It is presented in a package containing 10, 30, or 30 (3x10) heat-sealed PET/LDPE/Alu/PE sachets with 10 ml of oral solution per sachet.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

SAG MANUFACTURING S.L.U.

Crta N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

or

Galenicum Health, S.L.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid. Spain

Date of the last revision of this package leaflet:January 2023

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