Proaxon

Patient Information Leaflet

Proaxon
1000 mg/10 ml, oral solution
Citicoline
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Proaxon is and what it is used for

Proaxon contains citicoline as the active substance, which belongs to a group of medicines called psychostimulants and nootropics (so-called "cognitive enhancers"). These medicines work by improving brain function.
Proaxon is used in the treatment of neurological and cognitive disorders caused by:

• Interruption of blood supply to the brain due to blood clot formation or damage to cerebral blood vessels (e.g. stroke);
• Head injuries (e.g. resulting from trauma).

2. Information before using Proaxon

When not to use Proaxon:

• if the patient is allergic to citicoline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has increased activity of the parasympathetic nervous system, a serious condition characterized by low blood pressure, excessive sweating, rapid heartbeat, and fainting.

Warnings and precautions
Before starting treatment with Proaxon, consult a doctor:

• if the patient is allergic to acetylsalicylic acid, as this medicine may cause asthma attacks.

Children and adolescents
There is insufficient data on the use of Proaxon in children; therefore, this medicine should only be administered if a doctor decides it is necessary.

Proaxon with other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient intends to use.
Citicoline enhances the effects of L-dopa (also known as levodopa); therefore, concomitant use of these medicines should not be initiated without prior consultation with a doctor.
L-dopa is used in the treatment of Parkinson's disease.
Concomitant use of citicoline with meclofenoxate, a medicine that stimulates brain function, is not recommended.

Proaxon with food and drink
Proaxon can be taken on an empty stomach or with food.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Proaxon should not be used if the patient is pregnant, suspects she may be pregnant, or is breastfeeding, unless a doctor considers it necessary.

Driving and operating machinery
Proaxon has no influence on the ability to drive or operate machinery.
This medicine may cause asthma attacks, particularly in individuals allergic to acetylsalicylic acid.

Proaxon contains sorbitol (E420). The medicine contains 2000 mg of sorbitol per sachet, equivalent to 200 mg/ml. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Proaxon contains propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), and carmine red (E124). This medicine may cause allergic reactions (including delayed-type reactions).

The medicine contains 80.83 mg of sodium (a main component of table salt) per sachet. This corresponds to 4.04% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Proaxon

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is 1 to 2 sachets per day, depending on the severity of the disease symptoms.
This medicine may be taken directly or after dissolving in 120 ml of water (approximately half a glass
of water), during or between meals.

1. Take the Proaxon 2. With the other hand, 3. The medicine can be 4. after dissolving in
   sachet 1000 mg and tear the sachet along the taken directly or in half a glass of water
   shake it vigorously. perforated line. dissolved in 120 ml of water.

Taking more than the recommended dose of Proaxon
If more than the recommended dose of Proaxon is taken, consult a doctor immediately.
Bring the medicine packaging or this leaflet with you so that medical personnel know which medicine
has been taken.
Missing a dose of Proaxon
Take the missed dose as soon as possible.
Do not take a double dose to make up for a forgotten dose.
Stopping treatment with Proaxon
Your doctor will determine how long you should take Proaxon. Do not stop treatment without
consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring very rarely (less frequently than in 1 out of 10,000 people):

• hallucinations,
• headache, dizziness,
• changes in blood pressure (increased or decreased blood pressure),
• breathing difficulties (dyspnoea),
• nausea, vomiting, diarrhoea,
• facial flushing, urticaria, rash, purpura,
• oedema,
• chills.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety profile.

5. How to store Proaxon
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachets.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Proaxon contains

• The active substance is cytycoline. One millilitre of solution contains 100 mg of cytycoline (as the sodium salt). Each sachet (10 ml of solution) contains 1000 mg of cytycoline (as the sodium salt).
• Other ingredients are: sorbitol liquid, non-crystallising (E420), glycerol, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), potassium sorbate, sodium saccharinate, glyceroformal, carmine red (E124), citric acid, sodium citrate, strawberry flavour, purified water.

What Proaxon looks like and contents of the pack
Proaxon is a clear, pink oral solution with a strawberry flavour and odour.
The medicine is packed in sachets made of PET/PX/Aluminium/RT foil, each containing 10 ml of solution, placed in a cardboard box.
The pack contains 10 sachets of 10 ml solution each.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Manufacturer
SAG MANUFACTURING, S.L.U
Crta. N-I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain

Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain