Citicoline Cinfamed 1000 mg oral solution EFG

Spain
Brand name Citicoline Cinfamed 1000 mg oral solution EFG
Form solution, oral
Active substance / Dosage
SODIUM CITICOLINE · 1,04500 g
Prescription type Prescription Only Medicine
ATC code
N06B N06BX N06BX06
Registration number 80484
Manufacturer Laboratorios Cinfa S.A.
Citicoline Cinfamed 1000 mg oral solution EFG solution, oral

Table of Contents

Patient Information Leaflet

Introduction

Patient Information Leaflet

CiticolinaCinfamed 1000 mg oral solution EFG

Please read this entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Leaflet Contents

  1. What Citicolina Cinfamed is and what it is used for
  2. What you need to know before taking Citicolina Cinfamed
  3. How to take Citicolina Cinfamed
  4. Possible adverse effects
  5. How to store Citicolina Cinfamed
  6. Contents of the pack and other information

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

Citicoline belongs to a group of medicines called psychostimulants and nootropics, which work by improving brain function.

Citicolina Cinfamed is used to treat memory and behavioral disorders caused by:

  • stroke, which is an interruption of blood supply to the brain due to a blood clot or rupture of a blood vessel.

head trauma, which is a head injury.

2. What you need to know before starting to take Citicoline Cinfamed

Do not take Citicoline Cinfamed

  • if you are allergic to the active substance citicoline or to any of the other ingredients of this medicine (listed in section 6).
  • if you have parasympathetic nervous system hypertonia, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Citicoline Cinfamed

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

Children

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

Taking Citicoline Cinfamed with other medicines

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

Citicoline enhances the effects of L-Dopa; therefore, it should not be administered simultaneously with medicines containing L-Dopa without consulting your doctor. Medicines containing L-Dopa are commonly used to treat Parkinson's disease.

Citicoline should not be administered together with medicines containing meclofenoxate, a cerebral stimulant.

Taking Citicoline Cinfamed with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Citicolina Cinfamed contains sorbitol (E-420), carmine red A (Ponceau 4R) (E-124), parahydroxybenzoates (E-216 and E-218), propylene glycol (E-1520), and sodium

This medicine contains 78.76 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 3.85% of the maximum daily recommended sodium intake for an adult.

This medicine contains 1.4 g of sorbitol (E-420) per sachet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) 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 medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

It may cause allergic reactions (possibly delayed) because it contains propylparaben (E-216) and methylparaben (E-218).

This medicine contains 2.58 mg of propylene glycol (E-1520) per sachet.

3. How to take Citicoline Cinfamed

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 to 2 sachets per day, depending on the severity of your condition. To open the sachet properly, it is advisable to cut it along the dotted line with scissors.

It can be taken directly or dissolved in half a glass of water (120 ml), with or without food.

Two hands pulling a plastic strip labeled 1000 mg to separate doses of a medication

Two hands using scissors to cut the top off a cylindrical medication or medical device package

Line drawing of a person with open mouth taking powder poured from a sachet held by a hand

A hand pouring the contents of a liquid medication vial into

  1. Firmly hold the Citicoline Cinfamed 1000 mg sachet at the end and shake
  1. Cut the sachet with scissors

along the

arrows

  1. You may take it

directly from

the sachet or

  1. Dissolve it in

half a glass of

water (120 ml) and

drink it

If you take more CiticolinaCinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take CiticolinaCinfamed

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

If you stop taking CiticolinaCinfamed

Your doctor will determine the duration of your treatment with Citicolina. Do not discontinue treatment before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects of this medicine are very rare (may affect up to 1 in 10,000 patients). These may include headache, dizziness, nausea, occasional diarrhoea, facial flushing, swelling of the limbs, and changes in blood pressure. If you experience any of these or other symptoms, inform your doctor.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citicoline Cinfamed

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of CiticolinaCinfamed

  • The active substance is citicoline. Each sachet contains 1000 mg of citicoline (as the sodium salt).
  • The other components (excipients) are: sodium saccharin (E-954), non-crystallizable liquid sorbitol (E-420), glycerol (E-422), methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium citrate (E-331), glycerinformaldehyde, potassium sorbate (E-202), strawberry flavour (contains propylene glycol (E-1520)), cochineal red A (Ponceau 4R) (E-124), citric acid (E-330) and purified water.

Nature of the product and contents of the pack

Citicolina Cinfamed is a transparent pink oral solution with strawberry odour and flavour, packed in sachets.

It is available in packs containing 10 or 30 sachets, each with 10 ml of oral solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

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

Date of the most recent revision of this leaflet: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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

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