Gliatilin

Package leaflet: information for the patient

Gliatilin, 400 mg, soft capsules
Choline alfoscerate
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

2. Important information before taking Gliatilin
When not to take Gliatilin

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• in patients with psychotic syndromes and significant psychomotor agitation.

Warnings and precautions
Before starting Gliatilin, discuss it with your doctor or pharmacist.
Gliatilin and other medicines
Inform your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
Gliatilin can be used together with other medicines. Interactions are not known.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
The decision to use Gliatilin in pregnant women is made by the doctor.
Gliatilin must not be used during pregnancy unless absolutely necessary.
Breastfeeding
Women who are breastfeeding should not use Gliatilin.
Fertility
Animal studies regarding effects on pregnancy, embryo/fetal development, delivery, and postnatal development are insufficient. The potential risk to humans is unknown.
Driving and operating machinery
Gliatilin has no effect or has a negligible effect on the ability to drive and operate machinery.
Gliatilin contains sorbitan – 33 mg, sodium ethyl parahydroxybenzoate – 0.8 mg, sodium propyl parahydroxybenzoate – 0.4 mg.
Therefore:

• If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
• Gliatilin may cause allergic reactions (delayed-type reactions are possible).

3. How to take Gliatilin
This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
1 capsule two or three times daily.
Typically, 1 or 2 capsules in the morning and 1 capsule in the afternoon are administered.
Your doctor may recommend a different dosing regimen.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Gliatilin than recommended
Symptoms of overdose include: restlessness, agitation, insomnia, nausea.
If you have taken more medicine than you should, or if someone else has taken it, inform your doctor or pharmacist immediately.
Missing a dose of Gliatilin
If you miss a dose, take the next capsule at the time specified by the recommended dosing schedule.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor 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 everybody experiences them:

• during the first days or weeks of treatment, occasional symptoms such as anxiety, agitation, and insomnia may occur. These symptoms are transient and do not require discontinuation of the medicine, but only a temporary reduction in dose;
• 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 numbers of the above Department}
e-mail: [email protected]
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Gliatilin

Store 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 blister 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 pack and other information

What Gliatilin contains

• The active substance is cholinalfoscerate (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 aluminium/PVC blisters in a cardboard box.
14 soft capsules (1 blister with 14 capsules)
Marketing Authorisation Holder and Manufacturer
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.