Citicoline Normogen 1000 mg oral solution EFG

Spain
Brand name Citicoline Normogen 1000 mg oral solution EFG
Form solution, oral
Active substance / Dosage
SODIUM CITICOLINE · 1,045 g
Prescription type Prescription Only Medicine
ATC code
N06B N06BX N06BX06
Registration number 86656
Manufacturer Laboratorios Normon S.A.
Citicoline Normogen 1000 mg oral solution EFG solution, oral

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citicoline Normogen 1000 mg oral solution EFG

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

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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 Citicoline Normogen is and what it is used for
  2. What you need to know before taking Citicoline Normogen
  3. How to take Citicoline Normogen
  4. Possible side effects
  5. How to store Citicoline Normogen
  6. Contents of the pack and other information

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

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

Citicoline is used to treat memory and behavioural disturbances due to:

  • A stroke, which is an interruption of blood supply to the brain caused by a blood clot or rupture of a blood vessel.
  • A head injury, which is a blow to the head.

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

Do not take Citicolina Normogen

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Citicolina Normogen:

  • 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.

Other medicines and Citicolina Normogen

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 taken simultaneously with medications containing L-Dopa without consulting your doctor. Medications containing L-Dopa are commonly used to treat Parkinson's disease.

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

Taking Citicolina Normogen with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 Normogen 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 3.94% of the maximum recommended daily 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 metabolize fructose, consult your (or your child's) doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

Allergic reactions (possibly delayed) may occur because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

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

3. How to take Citicoline Normogen

Follow exactly the instructions for administration 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. It can be taken directly or dissolved in half a glass of water (120 ml), with or without food.

Two hands holding and pressing a strip of material or a rectangular medical device onto a light-colored surface

Two hands carefully handling a small cylindrical object or medical component between the fingers for preparation

Line drawing of a person with an open mouth receiving a

One hand carefully pouring a dark liquid from a small glass vial into a larger transparent container

  1. Hold the Citicoline Normogen 1000 mg sachet firmly by the end and shake it
  1. With the other hand

tear the sachet

along the

arrows indicated

  1. You may take it

directly from

the sachet or

  1. Dissolve it in

half a glass of

water (120ml) and

drink it

If you take more Citicolina Normogendel 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 medicine and the amount ingested.

If you forget to take CiticolinaNormogen

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

If you stop using CiticolinaNormogen

Your doctor will determine the duration of your treatment with citicoline. 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 may produce adverse effects, although not everyone will experience them.

The adverse effects of this medicine are very rare (may affect up to 1 in every 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citicoline Normogen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is 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. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citicoline Normogen

  • The active substance is citicoline. Each sachet contains 1,000 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), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formal, potassium sorbate (E-202), strawberry flavour (containing propylene glycol (E-1520)), carmine red A (Ponceau 4R) (E-124), anhydrous citric acid (E-330) and purified water.

Appearance of the product and contents of the pack

Citicoline Normogen is a transparent pink oral solution with strawberry odour and flavour, presented in sachets.

It is available in packs containing 10 or 30 sachets (multiple pack: 3 units of 10 sachets), each containing 10 ml of oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (Spain)

Manufacturer

Galenicum Health, S.L.

Avda. Cornellá 144, 7th floor - 1st floor, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona (Spain)

or

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix

Madrid (Spain)

Date of the most recent revision of this leaflet: March 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86656/P_86656.html.