Package leaflet: Information for the patient

Trausan 1000 mg oral solution

{Citicoline}
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Trausan 1000 mg oral solution is and what it is used for
What you need to know before taking Trausan 1000 mg oral solution
How to take Trausan 1000 mg oral solution
Possible side effects
How to store Trausan 1000 mg oral solution
Contents of the pack and other information

1. What Trausan 1000 mg oral solution is and what it is used for

Citicoline belongs to a group of medicines called psychostimulants and nootropics, and its action
improves neuronal membrane function.
Trausan 1000 mg oral solution is used to treat memory and behavioural disorders
caused by:

cerebrovascular accidents, i.e. lack of oxygen due to impaired blood flow to the brain caused by blockage or rupture of an artery supplying the brain
traumatic brain injuries, such as a severe blow to the head.

2. What you need to know before taking Trausan 1000 mg oral solution

Do not take Trausan 1000 mg oral solution:

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 associated with low blood pressure, sweating, rapid heartbeat, and fainting.

Children
Experience in children is limited; therefore, this medicine should only be administered when the doctor considers the benefit to outweigh any potential risks.
Other medicines and Trausan 1000 mg oral solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Trausan 1000 mg oral solution enhances the effects of medicines containing L-dopa and therefore must not be taken together with drugs containing L-dopa without informing your doctor. Medicines containing L-dopa are often used to treat Parkinson's disease.
Trausan 1000 mg oral solution must not be taken together with medicines containing meclofenoxate, a drug that stimulates brain activity.
Trausan 1000 mg oral solution with food and drinks
You may take this medicine with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Trausan 1000 mg oral solution will affect your ability to drive or use tools or machinery.
Trausan 1000 mg oral solution contains sorbitol, carmine red A, parahydroxybenzoates and sodium
This medicine contains sorbitol (E420). If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains carmine red A (also known as Ponceau 4R or E124), which may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.
It contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause hypersensitivity reactions (including delayed reactions).
Patients on a low-sodium diet should note that this medicine contains 50.1 mg of sodium per stick pack.

3. How to take Trausan 1000 mg oral solution

Take this medicine exactly as stated in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose ranges from 500 mg to 2000 mg daily, depending on the severity of the condition being treated. It can be taken directly from the stick pack or dissolved in half a glass of water (120 mL).
If you take more Trausan 1000 mg oral solution than you should
Contact your doctor, pharmacist, or the toxicology information service immediately.
If you forget to take Trausan 1000 mg oral solution
Do not take a double dose to make up for the forgotten dose.
If you stop taking Trausan 1000 mg oral solution
Do not stop treatment with this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects of this medicine are very rare (occurring in fewer than 1 in 10,000 people).
You may experience headache, dizziness, nausea, occasional diarrhoea, hot flushes, swelling of the extremities, and changes in blood pressure. If you experience any of these or other side effects, inform your doctor.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trausan 1000 mg oral solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the stick sachet and/or the cardboard box.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Trausan 1000 mg oral solution contains

The active substance is citicoline. 10 mL of citicoline solution contain 1000 mg of citicoline (as the sodium salt).
The other ingredients are sodium saccharin (E954), sorbitol (E420), glycerol (E422), sodium methyl parahydroxybenzoate (E218), sodium propyl parahydroxybenzoate (E217), potassium sorbate (E202), strawberry flavour, Ponceau 4R (E124), citric acid monohydrate (E330) and purified water.

Description of the appearance of Trausan 1000 mg oral solution and contents of the pack
Trausan 1000 mg oral solution is a transparent red to pink solution with a strawberry flavour, formulated in single-dose stick packs containing 1000 mg of citicoline.
Each pack contains 10 or 30 stick packs of 10 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PIAM Farmaceutici S.p.A.
Via Fieschi, 8
16121 Genova
Italy

Batch release responsible person
FAES FARMA, S.A.
Máximo Aguirre, 14
48940 Leioa