Gliatilin

Package Leaflet: Information for the Patient

Gliatilin, 400 mg, Soft Capsules

Cholini alfosceras

Read the package leaflet carefully before taking 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 tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Gliatilin and what is it used for

Gliatilin 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 neurotransmitters in the brain, 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 intake 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 clinical trials with volunteers 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 forms of dementia and post-traumatic disorders.
It has been found that choline alfoscerate is rapidly and completely absorbed from the gastrointestinal tract into the blood and rapidly distributed to many organs, including the brain. The elimination of the drug occurs through the kidneys.

Indications for the use of Gliatilin

Organic degenerative disorders of brain function (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 taking Gliatilin

When not to take Gliatilin

• in patients with psychotic disorders, with significant psychomotor agitation.

Warnings and precautions

Before taking Gliatilin, discuss it with your doctor or pharmacist.

Gliatilin 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 can be taken 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 taking this medicine.
Pregnancy
The use of Gliatilin in pregnant women is decided by the doctor.
Gliatilin should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Women who are breastfeeding should not take Gliatilin.
Fertility
Animal studies on the effects on pregnancy, embryonic/fetal development, childbirth, and postnatal development are insufficient. The potential risk to humans is not known.

Driving and using machines

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

Gliatilin contains sorbitan – 33 mg, sodium ethyl parahydroxybenzoate – 0.8 mg, sodium propyl parahydroxybenzoate – 0.4 mg.

Therefore:

• Gliatilin may cause allergic reactions (possible late reactions).

3. How to take Gliatilin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
1 capsule 2 or 3 times a day.
Usually, 1 or 2 capsules are taken in the morning and 1 capsule in the afternoon.
Your doctor may recommend a different dosing schedule.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor or pharmacist.

Overdose of Gliatilin

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

Missed dose of Gliatilin

If you miss a dose, take the next capsule at the time specified in the recommended dosing schedule.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of 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 not everybody gets them:

• during the first few days or weeks of treatment, anxiety, agitation, or insomnia may occasionally occur. 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 a reason to reduce the dose.

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

5. How to store Gliatilin

Store in a temperature below 25°C.
Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister 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 contains

• The active substance is choline alfoscerate (Cholini alfosceras).
• The other ingredients are: purified water, glycerol, gelatin, esitol, sorbitan, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide, iron (III) hydroxide (E 172).

What Gliatilin looks like and contents of the pack

Gliatilin is available in blisters of aluminum/PVC film in a cardboard box.
14 soft capsules (1 blister of 14 capsules)

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 partially sighted available at the representative of the marketing authorization holder.

Date of last revision of the leaflet: