Citicoline Qualigen 1000 mg oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CITICOLINE QUALIGEN 1000mg oral solution EFG

Read all of this 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 must not be given 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 adverse effects not listed in this leaflet.

Contents of this leaflet

1. What Citicoline Qualigen 1000 mg oral solution EFG is and what it is used for
2. What you need to know before taking Citicoline Qualigen 1000 mg oral solution EFG
3. How to take Citicoline Qualigen 1000 mg oral solution EFG
4. Possible side effects
5. How to store Citicoline Qualigen 1000 mg oral solution EFG
6. Contents of the pack and other information

1. What Citicolina Qualigen 1000 mg oral solution EFG is and what it is used for

Citicolina Qualigen belongs to a group of medicines called psychoanaleptics and nootropics, which work by improving brain function.

Citicolina Qualigen 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 blow to the head.

2. What you need to know before starting to take Citicolina Qualigen 1000 mg oral solution EFG

Do not take Citicolina Qualigen

• if you are allergic to citicoline or to any of the other ingredients of Citicolina Qualigen.
• 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 Citicolina Qualigen.

Take special care with Citicolina Qualigen

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

Taking Citicolina Qualigen with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

Citicolina Qualigen should not be administered concomitantly with medicines containing meclofenoxate, a cerebral stimulant.

Taking Citicolina Qualigen with food and drink

Citicolina may be taken with or without food.

Fertility, pregnancy, and breastfeeding

If you are pregnant, 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 and use machinery have been observed.

Important information about some of the ingredients of Citicolina Qualigen

This medicine contains Sorbitol (E-420). If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Due to the presence of Cochineal Red (Ponceau 4R or E-124), it may cause allergic-type reactions.

This medicine contains parahydroxybenzoates in the form of propyl esters (E-217) and methyl esters (E-218), which may cause allergic reactions (possibly delayed).

3. How to take Citicoline Qualigen 1000 mg oral solution EFG

Follow exactly the administration instructions for Citicoline contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse 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.

Use in children and adolescents

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

If you take more Citicoline Qualigen than you should

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken.

If you forget to take Citicoline Qualigen

Take your dose as soon as you remember.

Do not take a double dose to make up for forgotten doses.

If you stop taking Citicoline Qualigen

Your doctor will determine the duration of your treatment with Citicoline Qualigen. Do not stop treatment before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Citicolina Qualigen may have adverse effects, although not everyone experiences them.

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

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet.

Reporting of adverse reactions

If you experience any adverse effect, speak to your doctor, pharmacist, or nurse. This includes any possible adverse effects not mentioned in this leaflet.

You can report adverse effects 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 Qualigen 1000 mg oral solution EFG

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

Expiry

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.

Storage conditions

Store in the original packaging.

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

6. Contents of the pack and other information

What Citicolina Qualigen 1000 mg oral solution contains

• 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), Liquid sorbitol (E-420), Glycerol (E-422), Methylparaben (E-218), Propylparaben (E-217), Sodium citrate (E-331), Glycerinformaldehyde, Potassium sorbate (E-202), Strawberry flavour, Red Ponceau 4R colour (E-124), Citric acid (E-330) and Purified water.

What Citicolina Qualigen 1000 mg oral solution looks like and contents of the pack

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

It is available in a pack containing 10 sachets, each with 10 ml of oral solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Responsible for Marketing

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona - Spain

Manufacturer

FERRER INTERNACIONAL, S.A.

Buscallá, 1-9

08173 - Sant Cugat del Vallés

Barcelona (Spain)

Date of the most recent review of this leaflet: July 2013

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