Leaflet: information for the patient

CiticolinaCinfamed1000 mg oral solution EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What CiticolinaCinfamedis and for what it is used

2. What you need to know before starting to take CiticolinaCinfamed

3. How to take CiticolinaCinfamed

4. Possible side effects

5. Storage of CiticolinaCinfamed

6. Contents of the pack and additional information

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

CiticolinaCinfamedis 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 CiticolinaCinfamed

• if you are allergicto the active ingredient citicolina or to anyof 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 takeCiticolinaCinfamed

- 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.

Taking Citicolina Cinfamed

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyormayhave 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 Cinfamed with food and drinks

This medicationcan be taken with meals or without them.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour 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 Cinfamed contains

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 3.85% 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 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 delayed allergic reactions (possibly) 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.This medicationin case of doubt, consult your doctor or pharmacist again..

The recommended doseis 1 to 2 packets per day, depending on the severity of your illness.To open the packet correctly, it is advisable to cut it along the dotted line with scissors.

You can take it directly or dissolved in half a glass of water (120 ml) with meals or without them.

If you take more Citicolina Cinfamed 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 Cinfamed

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 Citicolina Cinfamed

Your doctor will indicate the duration of your treatment with Citicolina. Do not suspend the treatment before 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 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 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.

Keepthis medicationout of the sight and reachof children.

Do not use this medication after the expiration date that appears on the packagingafter "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 in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Citicolina Composition Cinfamed

- The active principle is citicoline. Each sachet contains 1000 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 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

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

It is presented in a package containing 10 or 30 sachets, each containing 10 ml of oral solution.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Galenicum Health, S.L.U

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix,

Madrid (Spain)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80484/P_80484.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80484/P_80484.html