Gliaton

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

Composition:

Active substance: choline alfoscerate;

1 capsule contains: choline alfoscerate – 400 mg;

Excipients: glycerin;

capsule shell composition: gelatin (160 bloom); sorbitol liquid, partially dehydrated; glycerin; iron oxide yellow (E 172); titanium dioxide (E 171); purified water.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, oval-shaped, yellowish-brown in color. The capsule contents – a viscous solution.

Pharmacotherapeutic group.

Agents affecting the nervous system. Parasympathomimetics. Choline alfoscerate.

ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Glyaton® is an agent belonging to the group of central cholinomimetics 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 may influence reduced cholinergic tone and altered phospholipid composition of nerve cell membranes. The formulation contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Glyaton® positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, which are impaired due to the development of brain involutional pathology.

The mechanism of action is based on the fact that upon entering the body, choline alfoscerate is enzymatically hydrolyzed into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the primary mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, Glyaton® enhances nerve impulse transmission in cholinergic neurons; positively influences neuronal membrane plasticity and receptor function. Glyaton® improves cerebral blood flow, enhances metabolic processes in the brain, activates structures of the brain's reticular formation, and restores consciousness following traumatic brain injury.

Pharmacokinetics.

After administration, approximately 88% of the administered dose of Glyaton® is absorbed on average. The drug accumulates predominantly in the brain (45% of the drug concentration in blood), 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 ability to concentrate; emotional and behavioral changes: emotional instability, irritability, indifference towards the surrounding environment; pseudomelancholia in elderly individuals.

Contraindications.

Known hypersensitivity to any component of the medicinal product.

Patients with psychotic syndrome or severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

If an intolerance to certain sugars has been established, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

The medication is intended for adult use only.

Take 1 capsule 2 or 3 times daily.

The duration of treatment is determined individually by a physician.

Children.

There is no experience with the use of Gliaton® in children.

Overdose.

In case of Gliaton® overdose, which may manifest as nausea, restlessness, excitement, or insomnia, the dose of the medication should be reduced. Symptomatic therapy is recommended.

Side effects.

The drug is generally well tolerated even with long-term 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, although a temporary dose reduction may be considered.

Possible nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache; very rarely abdominal pain and transient confusion may occur. In such cases, the dose of the drug should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioneurotic edema, and skin redness. The drug may cause allergic reactions (possibly delayed).

Shelf life. 2 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 capsules in a blister. 3 or 6 blisters in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.