Prospect: information for the patient

Citicolina Kern Pharma 1.000 mg oral solution EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

•Keep this prospect, as you may need to read it again.

•If you have any doubts, consult your doctor, pharmacist, or nurse.

•This medicine has been prescribed only to you, and you must not give it to other people 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 prospect. See section 4.

1. What is Citicolina Kern Pharma and for what it is used

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

3. How to take Citicolina Kern Pharma

4. Possible adverse effects

5. Storage of Citicolina Kern 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 cerebral vascular 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 CiticolinaKern 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 autonomic nervous system hyperactivity, a serious 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 CiticolinaKern Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need 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 CiticolinaKern Pharmawith food and drinks

This medication can be taken with meals or outside of 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.

CiticolinaKern Pharmacontains sorbitol (E-420), red cochineal 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/for cooking) in each 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) in each sachet. Sorbitol is a source of fructose. If your doctor has indicated 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 (or your child) before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication may cause allergic reactions because it contains red cochineal A (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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 without them.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Citicolina Kern 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 Kern Pharma

Your doctor will indicate the duration of your treatment with citicolina. Do not discontinue 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 produce adverse effects, although not all people will experience them.

The adverse effects of this medication are very rare (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 may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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 storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Citicolina Kern Pharma Composition

- 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), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formal, potassium sorbate (E-202), strawberry flavor (contains propylene glycol (E-1520)), red cochineal A (Ponceau 4R) (E-124), anhydrous citric acid (E-330), and purified water.

Appearance of the product and contents of the packaging

Citicolina Kern Pharma is a transparent oral solution of pink color, with strawberry smell and taste, 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – 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: March 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/