Gliatilin 1000

Package Leaflet: Information for the Patient

Gliatilin 1000, 250 mg/ml, Solution for Injection

Cholini alfosceras

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Gliatilin 1000 and what is it used for
• 2. Important information before using Gliatilin 1000
• 3. How to use Gliatilin 1000
• 4. Possible side effects
• 5. How to store Gliatilin 1000
• 6. Contents of the pack and other information

1. What is Gliatilin 1000 and what is it used for

Gliatilin 1000 contains the active substance – choline alfoscerate, which enhances the activity of the cholinergic system and improves the function of the neuronal cell membrane. Choline alfoscerate is a precursor of phosphatidylcholine and a carrier of choline – a direct precursor of acetylcholine (ACh).
Acetylcholine, one of the most important brain neurotransmitters, plays a crucial role in the functions of the central nervous system, such as: memory, emotions, and motor functions.
In various degenerative and post-traumatic brain disorders, the acetylcholine system is damaged – selectively or primarily. Increased choline supply increases the amount of ACh, and thus the activity of the system, which significantly reduces the symptoms of brain damage. The chemical structure of choline alfoscerate (containing 40.5% choline) and its physicochemical properties ensure a significant supply of the active substance to the brain, protecting metabolic processes.
Furthermore, choline alfoscerate facilitates the re-incorporation of phospholipids lost during aging, damage, or degeneration of the brain into the neuronal cell membrane.
The proper composition of phospholipids in the neuronal cell membrane is essential for its proper function, which determines nerve conduction and transmission.
The results of preclinical pharmacological studies and volunteer studies demonstrate that choline alfoscerate significantly improves impaired memory and other cognitive functions, as well as having a beneficial effect on the affective and behavioral sphere.
Long-term clinical experience to date confirms these observations in elderly patients with various dementia and post-traumatic syndromes.
It has been found that choline alfoscerate is rapidly and completely absorbed from the gastrointestinal tract into the blood and rapidly distributed in many organs, including the brain. The elimination of the drug occurs through the kidneys.

Indications for use of Gliatilin 1000

Involutional organic brain function disorders (cognitive disorders – memory disorders, disorientation, decreased motivation, decreased concentration; affective and behavioral disorders – emotional instability, irritability, loss of interest in the environment). Pseudodepression of old age.

2. Important information before using Gliatilin 1000

When not to use Gliatilin 1000

• in patients with psychotic syndromes with significant psychomotor agitation.

Warnings and precautions

Before starting to use Gliatilin 1000, discuss it with your doctor or pharmacist.

Gliatilin 1000 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Gliatilin 1000 can be used with other medicines. Interactions are not known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Gliatilin 1000 in pregnant women is decided by the doctor.
Gliatilin 1000 should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Women who are breastfeeding should not use Gliatilin 1000.
Fertility
Animal studies on the effect on pregnancy, embryonic/fetal development, childbirth, and postnatal development are insufficient. The potential risk to humans is not known.

Driving and using machines

Gliatilin 1000 has no influence or insignificant influence on the ability to drive and use machines.

3. How to use Gliatilin 1000

This medicine should always be used according to the doctor's or pharmacist's recommendations. If you are unsure, ask your doctor or pharmacist.
Recommended dose
Solution from 1 ampoule intramuscularly 1 time a day.
The doctor may recommend a different dosing regimen.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor or pharmacist.

Using a higher dose of Gliatilin 1000 than recommended

Symptoms of overdose are: anxiety, agitation, insomnia, nausea.
If you have taken a higher dose of the medicine than you should, or if someone else has taken it, tell your doctor or pharmacist immediately.

Missing a dose of Gliatilin 1000

In case of a missed dose, take the next dose at the time resulting from the recommended dosing regimen.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

As a precursor of biologically active substances, choline alfoscerate is usually well-tolerated, even in long-term treatment.
Like all medicines, this medicine can cause side effects, although they may not occur in everyone.

• in the first few days or weeks of treatment, the following may occasionally occur: anxiety, agitation, insomnia. These symptoms are transient and do not require withdrawal of the medicine, but only temporary reduction of the dose;
• possible occurrence of nausea, most likely due to secondary stimulation of the dopaminergic system, may be an indication for dose reduction.

Reporting side effects
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to:
Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address, phone and fax number of the above Department}
e-mail: adr@urpl.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Gliatilin 1000

Store in a temperature below 25°C.
Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gliatilin 1000 contains

• The active substance of the medicine is choline alfoscerate (Cholini alfosceras).
• The other ingredient is: water for injections.

What Gliatilin 1000 looks like and contents of the pack

Gliatilin 1000 is available in colorless glass ampoules in a cardboard box.
3 glass ampoules of 4 ml each

Marketing authorization holder and manufacturer

Italfarmaco S.p.A
Viale Fulvio Testi 330
20126 Milan
Italy

Representative of the marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
ul. Podleśna 83, 05-552 Łazy
tel. (22) 70 28 200
email: angelini@angelini.pl
Patient leaflet in a format suitable for the blind and visually impaired available at the representative's office of the marketing authorization holder.

Date of last revision of the leaflet: