Package Insert: Information for the Patient

Citicolina Pensa Pharma 1000 mg Oral Solution EFG

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

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

1. What is Citicolina Pensa Pharma and how is it used

2. What you need to know before starting to take Citicolina Pensa Pharma

3. How to take Citicolina Pensa Pharma

4. Possible adverse effects

5. Storage of Citicolina Pensa Pharma

6. Contents of the package and additional information

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

Citicolina is 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 take Citicolina Pensa Pharma

• if you are allergicto the active ingredient citicolina or to any of the other components ofthis medication (listed in section 6).
• if you have autonomic nervous system hypertension, a serious condition with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takeCiticolina Pensa Pharma

- 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 Pensa Pharma

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

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.

Taking Citicolina Pensa Pharma with food and drinks

This medication can be taken with meals or without them.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Citicolina Pensa Pharma contains sorbitol (E-420), red 4R (Ponceau 4R) (E-124), and 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/for cooking) in each sachet. This is equivalent to 3.85% of the recommended daily maximum sodium intake for an adult.

This medication contains 2 g of sorbitol (E-420) in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a fructose intolerance, 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 discomfort and a mild laxative effect.

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

This medication 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) in each sachet. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

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

The usual 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 without them.

If you take more Citicolina Pensa Pharma than you should

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

If you forget to take Citicolina Pensa Pharma

Take your dose as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citicolina Pensa Pharma

Your doctor will indicate the duration of your treatment with Citicolina Pensa Pharma. Do not stop treatment without consulting your doctor.

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

Like all medications, this medication may have adverse effects, although not everyone will experience them.

The adverse effects of this medication are very rare (they may affect up to 1 in 10,000 patients). It may cause 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.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human UseWebsite: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 after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Citicolina Pensa Pharma Composition

- The active ingredient is citicoline. Each sachet contains 1000 mg of citicoline (as sodium salt).

- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420), glycerol (E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), red cochineal A (Ponceau 4R) (E-124), citric acid (E-330), and purified water.

Appearance of the product and contents of the packaging

Citicolina Pensa Pharma is a transparent oral solution of pink color, with a strawberry smell and taste, packaged in sachets.

It is presented in a packaging that contains 10 or 30 sachets with 10 ml of oral solution each. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

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)

Last review date of this leaflet: July 2020

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