Neurotylin

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

Composition:

active substance: choline alfoscerate;

7 ml of the preparation contains 600 mg of choline alfoscerate;

excipients: methylparaben (E 218); propylparaben (E 216); sodium saccharin; strawberry flavoring containing propylene glycol, flavoring substances (natural and nature-identical); purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless or almost colorless solution with a strawberry taste.

Pharmacotherapeutic group.

Agents acting on the nervous system. Parasympathomimetics. Choline alfoscerate.

ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

The medicinal product belongs 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 ability 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. The medicinal product positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, 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 principal mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, the medicinal product enhances nerve impulse transmission in cholinergic neurons and exerts a positive effect on neuronal membrane plasticity and receptor function. The medicinal product 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.

Data are available indicating that pharmacokinetic properties, determined using radiolabeled compound, are similar across various animal species and are as follows: rapid and complete gastrointestinal absorption; rapid uptake and distribution in various organs and tissues, including the brain; exclusively renal excretion (approximately 10% of the administered radioactive dose within 96 hours); 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 patients, characterized by memory disturbances, confusion, disorientation, reduced motivation and initiative, decreased ability to concentrate; emotional and behavioral changes: emotional instability, irritability, indifference towards the environment; pseudomelancholia in elderly patients.

Contraindications.

Known hypersensitivity to the medicinal product or to any of its components.

In patients with psychotic disorders or severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other types of interactions.

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

Special precautions.

Nausea may occur (likely due to secondary dopaminergic activation). In such a case, the dose of the drug should be reduced. Efficacy and safety of the drug use in children under 18 years of age have not been established.

The presence of methylparaben (E 218) and propylparaben (E 216) in the formulation may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

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

Method of administration and dosage.

Take one vial or one sachet of oral solution twice a day.

The indicated dose may be increased by a physician.

Children.

Experience with the use of the medicinal product in children is lacking.

Overdose.

In case of overdose of the medicinal product, which may manifest as nausea, restlessness, excitement, and insomnia, the dose of the drug should be reduced.

Treatment: symptomatic therapy, use of adsorbent medicinal products (e.g., activated charcoal). The effectiveness of dialysis has not been established.

Side effects.

The drug is generally well tolerated even with long-term use.

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

Nausea (mainly due to secondary dopaminergic activation) may occur, as well as decreased blood pressure, headache, and very rarely abdominal pain and short-term confusion. In such cases, the drug dosage 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.

Storage conditions.

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

Keep out of reach of children.

Packaging. 7 ml in bottles No. 10 in a box; 7 ml in sachets No. 20 in a box.

Prescription status. Prescription only.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.