Prospect: information for the user

CITOCOLINA QUALIGEN 1000mg solution for oral use EFG

Read this prospect carefully before starting to take the medicine, because 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 medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect.

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

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

3.How to take Citicolina Qualigen 1000mg solution for oral use EFG

4.Possible adverse effects

5.Storage of Citicolina Qualigen 1000mg solution for oral use EFG

6.Contents of the package and additional information

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

Citicolina Qualigen is 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 Citicolina Qualigen

• if you are allergic to citicolina or any of the other components of Citicolina Qualigen.
• if you have hypotonia of the parasympathetic nervous system, which is a serious condition with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Consult with your doctor, pharmacist, or nurse before starting to take Citicolina Qualigen

Be especially careful with Citicolina Qualigen

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

Use of Citicolina Qualigen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

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

Use of Citicolina Qualigen with food and beverages

Citicolina can be taken with meals or without them.

Fertility, pregnancy, and breastfeeding

If you are pregnant, or in a breastfeeding period, think you may be pregnant, or intend to become 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.

Important information about some of the components of Citicolina Qualigen

This medication contains Sorbitol (E-420). If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

As it contains Cochineal Red (Ponceau 4R or E-124) it may cause allergic reactions.

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

Follow exactly the administration instructions for Citicolina contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse 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.

Use in children and adolescents

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

If you take more Citicolina Qualigen than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Citicolina Qualigen

Take your dose as soon as you remember.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citicolina Qualigen

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

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

Like all medications, Citicolina Qualigen may have adverse effects, although not all people will experience them.

The adverse effects of this medication are very rare (less than 1 in 10,000 patients). It may appear as 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.

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

Reporting Adverse Reactions

If you experience any adverse effect, speak with your doctor, pharmacist, or nurse. This includes any possible adverse effect not indicated in this prospectus.

You can report this adverse effect directly through the Spanish System of Pharmacovigilance of Medicines for Human Use website:www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medication

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

Expiration Date

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.

Storage Conditions

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

What Citicolina Qualigen 1000 mg oral solution contains

• The active ingredient is citicoline. Each pack contains 1000 mg of citicoline (as sodium salt).

• The other components (excipients) are: Sodium saccharin (E-954), Liquid sorbitol (E-420), Glycerol (E-422), Methyl parahydroxybenzoate (E-218), Propyl parahydroxybenzoate (E-217), Sodium citrate (E-331), Glycerol formaldehyde, Potassium sorbate (E-202), Strawberry flavor, Red Ponceau 4R color (E-124), Citric acid (E-330), and Purified water.

What Citicolina Qualigen 1000 mg oral solution looks like and what the packaging contains

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

It is presented in a packaging that contains 10 sachets with 10 ml of oral solution each.

Only some packaging 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

Responsible for manufacturing

FERRER INTERNACIONAL, S.A.

Buscallá, 1-9

08173-Sant Cugat del Vallés

Barcelona (Spain)

Last review date of this leaflet: July 2013

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