Alzmerat

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALZHMERAT (ALZHMERAT)

Composition:

Active substance: choline alfoscerate;

7 ml of solution contains choline alfoscerate 600 mg;

Excipients: methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sodium saccharin, orange flavor (containing propylene glycol), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless or almost colorless solution.

Pharmacotherapeutic group.

Agents affecting the nervous system. Other agents affecting the nervous system. Parasympathomimetics. Other parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Alzhemarat belongs to the group of central cholinomimetic agents with predominant effects 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 medicinal product contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Alzhemarat exerts a positive effect on memory functions and cognitive abilities, as well as on emotional state and behavioral parameters, the deterioration of which was caused by 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 main mediators of excitatory nerve impulse transmission; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, Alzhemarat improves nerve impulse transmission in cholinergic neurons, positively influences neuronal membrane plasticity and receptor function. Alzhemarat 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.

In studies conducted on various animal species using radiolabeled compounds, the following pharmacokinetic properties of choline alfoscerate were identified: rapid and complete gastrointestinal absorption (on average, approximately 88% of the administered dose is absorbed); rapid uptake and distribution in various organs and tissues. Choline alfoscerate crosses the blood-brain barrier. The drug accumulates predominantly in the brain (brain concentration reaches 45% of plasma concentration), lungs, and liver. Only renal excretion was observed (approximately 10% of the administered radioactive dose within 96 hours), along with higher brain availability compared to tritium-labeled choline.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to choline alfoscerate or to any of the excipients.

Psychosomatic syndrome, severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Clinically significant interaction of choline alfoscerate with other medicinal products has not been established.

Special precautions for use.

Nausea may occur (likely due to secondary dopaminergic activation). In such cases, the dose of the medicinal product should be reduced. The efficacy and safety of the drug in children (under 18 years of age) have not been established.

The presence of methyl 4-hydroxybenzoate (E 218) and propyl 4-hydroxybenzoate (E 216) in the formulation may cause allergic reactions (possibly delayed).

This medicinal product contains less than 1 mmol (23 mg) per dose of sodium, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

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

Method of administration and dosage.

Take one oral solution vial twice daily.

The indicated dose may be increased by a physician.

Children.

There is no experience with the use of Alcemerat in children.

Overdose.

In case of Alcemerat overdose, which may manifest as nausea, restlessness, excitement, and insomnia, the dose of the medicinal product should be reduced. Treatment: symptomatic therapy, administration of adsorbent medicinal agents (e.g., activated charcoal). The effectiveness of dialysis has not been established.

Adverse Reactions

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 necessary.

Possible adverse effects include nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, and very rarely abdominal pain and brief episodes of confusion. In such cases, the drug dosage should be reduced.

Hypersensitivity reactions may occur, including rash, pruritus, urticaria, angioedema, and skin redness. The medicinal product may cause allergic reactions (possibly delayed).

Reporting of adverse reactions after marketing authorization is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

7 ml of solution in a vial; 10 vials per carton box.

7 ml of solution in a vial; 1 vial per cardboard pack; 10 packs in a carton box.

Prescription status.

Prescription-only.

Manufacturer.

JSC "Tekhnolog"

Manufacturer's address and location of business activity.

8 Staroproryzna Street, Uman, Cherkasy region, 20300, Ukraine