Prospect: information for the patient

Citicolina Normogen 1000 mg oral solution EFG

Read this prospect carefully before starting to take this medication, as 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 medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

•If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Citicolina Normogen

3. How to take Citicolina Normogen

4. Possible adverse effects

5. Storage of Citicolina Normogen

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 stroke, 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 CiticolinaNormogen

•If you are allergic to citicoline or 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 Normogen:

- If you are allergic to acetylsalicylic acid, as it may cause asthma.

Children

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

Other medications and CiticolinaNormogen

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

Citicoline 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.

Citicoline should not be administered concurrently with medications containing meclofenoxate, which is a central nervous system stimulant.

Taking CiticolinaNormogenwith 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 have been observed on the ability to drive and operate machinery.

CiticolinaNormogencontains sorbitol (E-420), red 4R (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 recommended daily maximum sodium intake 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 told you that you (or your child) have a fructose intolerance, 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 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.

It may produce 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 of 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 Normogenthan 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 CiticolinaNormogen

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

If you interrupt the treatment with CiticolinaNormogen

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 (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 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 the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Citicolina Normogen Composition

- The active ingredient is citicoline. Each sachet contains 1,000 mg of citicoline (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 content of the packaging

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

It is presented in a packaging containing 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

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760, Tres Cantos

Madrid (Spain)

Responsible for manufacturing

Galenicum Health, S.L.

Avda. Cornellá 144, 7º- 1ª, Edificio Lekla

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