Package leaflet: Information for the patient

Gliatilin 1000, 250 mg/ml, solution for injection
Choline alphoscerate
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of the leaflet:

What Gliatilin 1000 is and what it is used for
Important information before using Gliatilin 1000
How to use Gliatilin 1000
Possible side effects
How to store Gliatilin 1000
Contents of the package and other information

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

Gliatilin 1000 contains the active substance choline alphoscerate, which enhances the activity of the cholinergic system and improves neuronal cell membrane function. Choline alphoscerate is a precursor of phosphatidylcholine and also provides choline – the direct precursor of acetylcholine (ACh).
Acetylcholine, one of the most important neurotransmitters in the brain, plays a crucial role in central nervous system functions such as memory, emotions, and motor functions.
In various degenerative and post-traumatic brain disorders, the acetylcholinergic system is selectively or primarily impaired. Increased choline supply increases ACh levels, thereby enhancing system activity and significantly reducing symptoms of brain damage. The chemical structure of choline alphoscerate (containing 40.5% choline) and its physicochemical properties ensure a significant delivery of the active substance to the brain, protecting metabolic processes.
Moreover, choline alphoscerate facilitates the reintegration of phospholipids lost during aging, brain injury, or degeneration into neuronal cell membranes.
An appropriate phospholipid composition of neuronal cell membranes is essential for their proper function, which determines nerve conduction and neurotransmission.
Results from preclinical pharmacological studies and studies involving volunteers demonstrate that choline alphoscerate significantly improves impaired memory and other cognitive functions, and also exerts beneficial effects on affective and behavioral domains.
Clinical experience over many years confirms these observations in elderly patients with various dementing and post-traumatic syndromes.
Choline alphoscerate has been shown to be rapidly and completely absorbed from the gastrointestinal tract into the bloodstream, with rapid distribution to various organs, including the brain. Elimination of the drug occurs via the kidneys.
Indications for Gliatilin 1000
Organic brain dysfunction due to aging (cognitive disorders – memory impairment, disorientation, reduced motivation, decreased concentration; affective and behavioral disorders – emotional instability, irritability, diminished interest in surroundings). Pseudodepression in the elderly.

2. Important information before using Gliatilin 1000

When not to use Gliatilin 1000

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
in patients with psychotic disorders accompanied by significant psychomotor agitation.

Warnings and precautions
Before starting treatment with Gliatilin 1000, discuss this with your doctor or pharmacist.
Gliatilin 1000 and other medicines
You must tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Gliatilin 1000 may be used together with other medicines. Interactions are not known.
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 her doctor or pharmacist before using this medicine.

Pregnancy
The decision to use Gliatilin 1000 in pregnant women is made by a physician.
Gliatilin 1000 must not be used during pregnancy unless absolutely necessary.

Breastfeeding
Women who are breastfeeding should not use Gliatilin 1000.

Effect on fertility
Animal studies on the effects on pregnancy course, embryo/fetal development, delivery, and postnatal development are insufficient. The potential risk to humans is unknown.

Driving and operating machinery
Gliatilin 1000 has no effect or has negligible effect on the ability to drive vehicles and operate machinery.

3. How to use Gliatilin 1000

This medicine should always be used as directed by a physician or pharmacist. In case of doubts,
consult a physician or pharmacist.
Recommended dose
One ampoule as an intramuscular injection once daily.
The physician may recommend a different dosing regimen.
If the effect of the medicine appears too strong or too weak, consult a physician or
pharmacist.
Use of a higher than recommended dose of Gliatilin 1000
Symptoms of overdose include: anxiety, agitation, insomnia, nausea.
If a patient has taken more medicine than recommended, or if someone else has taken it,
inform a physician or pharmacist immediately.
Missed dose of Gliatilin 1000
If a dose is missed, the next dose should be taken at the time specified by the recommended dosing schedule.
Do not use a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

As a precursor of biological substances, choline alfoscerate is generally well tolerated, even during long-term treatment.
Like any medicinal product, this medicine may cause adverse effects, although not everyone will experience them.

During the first days or weeks of treatment, the following may occasionally occur: anxiety, restlessness, insomnia. These symptoms are transient and do not require discontinuation of the medicine, but only a temporary reduction in dose;
Possible occurrence of nausea, most likely resulting from secondary stimulation of the dopaminergic system, may indicate a need to reduce the dose.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above-mentioned Department}
e-mail: [email protected]
Reporting adverse effects allows the collection of additional information on the safety of using the medicine.

5. How to store Gliatilin 1000

Store below 25°C.
Keep 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 stated month.
Medicines must 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 package and other information

What Gliatilin 1000 contains

The active substance is Choline alfoscerate (Cholini alfosceras).
The other component is: water for injections.

What Gliatilin 1000 looks like and contents of the pack
Gliatilin 1000 is available in colourless glass ampoules packed in a cardboard box.
3 glass ampoules of 4 ml each

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

Representative of the Marketing Authorisation Holder
Angelini Pharma Polska Sp. z o.o.
ul. Podleśna 83, 05-552 Łazy
tel. (22) 70 28 200
email: [email protected]
representative of the marketing authorisation holder.