Gliatilin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLIATILIN (GLIATILIN®)

Composition:

Active substance: choline alfoscerate;

1 capsule contains 400 mg of choline alfoscerate;

Excipients: glycerin, purified water;

capsule shell: gelatin, partially dehydrated liquid sorbitol, sodium ethylparahydroxybenzoate (E 215), sodium propylparahydroxybenzoate (E 217), titanium dioxide (E 171), iron oxide (E 172), glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: yellow oval soft opaque gelatin capsules containing a viscous solution.

Pharmacotherapeutic group.

Agents acting on the nervous system. Parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Gliatilin belongs to the group of central cholinomimetic agents with a predominant effect on the central nervous system (CNS). Choline alfoscerate, as a choline carrier and a precursor of phosphatidylcholine, has the potential to prevent and correct biochemical impairments that are particularly significant among the pathogenic factors of psychorganic involutional syndrome; thus, it can influence reduced cholinergic tone and altered phospholipid composition of nerve cell membranes. The medicinal product contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Gliatilin exerts a positive effect on memory functions and cognitive abilities, as well as on emotional state and behavioral parameters, the deterioration of which is caused by the development of brain involutional pathology.

The mechanism of action is based on the fact that after entering the body, choline alfoscerate is hydrolyzed by enzymes into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the main mediators of nerve excitation; glycerophosphate serves as a precursor of neuronal membrane phospholipids (phosphatidylcholine). Thus, Gliatilin improves nerve impulse transmission in cholinergic neurons; exerts a positive effect on neuronal membrane plasticity and receptor function. Gliatilin improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the brain's reticular formation, and restores consciousness in traumatic brain injury.

Pharmacokinetics.

On average, approximately 88% of the administered dose of Gliatilin is absorbed. The drug accumulates predominantly in the brain (45% of the plasma concentration), lungs, and liver. Elimination of the drug occurs mainly via the lungs in the form of carbon dioxide (CO₂). Only 15% of the drug is excreted in urine and bile.

Clinical characteristics.

Indications.

Degenerative-involutional cerebral psycho-organic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive disorders in elderly individuals characterized by memory impairment, confusion, disorientation, reduced motivation and initiative, and decreased concentration ability; emotional and behavioral changes: emotional instability, irritability, indifference towards the surrounding environment; pseudomelancholia in elderly individuals.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Psychotic syndrome, severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interactions.

Clinically significant interaction of the drug with other medicinal products has not been established.

Special precautions for use.

If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains 41 mg of sorbitol in each capsule. The additive effect of concomitant use of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be taken into account. The sorbitol content in oral medicinal products may alter the bioavailability of other orally administered medicinal products taken concomitantly.

The medicinal product contains sodium ethylhydroxybenzoate and sodium propylhydroxybenzoate, which may cause allergic reactions (possibly delayed).

The medicinal product contains less than 1 mmol (23 mg) of sodium per capsule and is therefore essentially "sodium-free".

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed while driving or operating machinery.

The medicinal product does not affect reaction speed while driving or operating machinery.

Method of administration and dosage.

The medicinal product should be used only in adults.

Take 1 capsule 2 or 3 times a day.

The duration of treatment is determined individually by a physician.

Children. Experience with the use of Gliatilin in children is lacking.

Overdose.

In case of Gliatilin overdose, which may manifest as nausea, restlessness, excitement, and insomnia, the dose of the drug should be reduced. Symptomatic therapy should be administered.

Adverse Reactions

The drug is generally well tolerated, even during prolonged use.

During the first days or weeks of treatment, the following adverse reactions may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be considered.

Possible adverse effects include nausea (primarily due to secondary dopaminergic activation), decreased blood pressure, headache, and very rarely abdominal pain and short-term confusion. In such cases, the dose of the medicinal product should be reduced.

Hypersensitivity reactions may occur, including rash, pruritus, urticaria, angioneurotic edema, and skin redness. Gliatilin may cause allergic reactions (including delayed-type reactions).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug registration is important. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life: 3 years.

Storage conditions

Store at a temperature not exceeding 30 °C. Keep out of reach and sight of children.

Packaging

14 capsules in a blister pack made of aluminum foil and PVC film, 1 blister per cardboard box.

Prescription status: Prescription only.

Manufacturer/Marketing Authorization Holder

Catalent Italy S.P.A., Italy (responsible for manufacturing of bulk product); Italfarmaco S.p.A., Italy (responsible for primary and secondary packaging, quality control, and batch release) / Italfarmaco S.p.A., Italy.

Address of manufacturer and its place of business activity / Address of marketing authorization holder

Via Netunense Km. 20, 100 – 04011 Aprilia (LT), Italy; Viale Fulvio Testi, 330, 20126 Milan (MI), Italy / Viale Fulvio Testi, 330, 20126 Milan (MI), Italy.