INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT T-CHOLINE® T-CHOLINE®

Composition:

Active substance: choline alfoscerate;

1 ml of solution contains choline alfoscerate (calculated as anhydrous choline alfoscerate) 250 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless or slightly yellow solution practically free from visible particles.

Pharmacotherapeutic group. Drugs affecting the nervous system. Parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological Properties

Pharmacodynamics. Choline alfoscerate is a drug belonging to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). As a choline carrier and a precursor of phosphatidylcholine, choline alfoscerate 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 drug contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Choline alfoscerate positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, which have been 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 main mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, choline alfoscerate improves nerve impulse transmission in cholinergic neurons, positively influences neuronal membrane plasticity and receptor function. Choline alfoscerate enhances cerebral circulation, stimulates 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 dose of choline alfoscerate is absorbed on average. The drug accumulates predominantly in the brain (45% of the plasma concentration), lungs, and liver. Elimination 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. Acute period of severe traumatic brain injury with predominantly brainstem-level damage (impaired consciousness, coma, focal hemispheric symptoms, brainstem lesion signs).

Degenerative-involutional cerebral psycho-organic 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 to the surrounding environment; pseudomelancholia in elderly patients.

Contraindications. Hypersensitivity to the components of the medicinal product.

Psychotic syndrome, severe psychomotor agitation.

Pregnancy or lactation period.

Interaction with other medicinal products and other forms of interaction. Clinically significant interaction of the medicinal product with other drugs has not been established.

Usage Notes

Use during pregnancy or breastfeeding. The medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to affect 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.

In acute conditions, administer T-CHOLINE® intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) daily for 15–20 days. Then, after stabilization of the patient's condition, switch to the capsule formulation.

Children. Experience with the use of T-CHOLINE® in children is lacking.

Overdose. In case of overdose of T-CHOLINE®, which may manifest as nausea, restlessness, excitement, and insomnia, the dose should be reduced. Treatment is symptomatic.

Side effects

The medicinal product is generally well tolerated, even with long-term use. Injection site reactions may occur. During the first days or weeks of treatment, the following adverse reactions may appear: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment; however, a temporary dose reduction may be necessary.

Nausea (primarily due to secondary dopaminergic activation), decreased blood pressure, headache may possibly occur; abdominal pain and short-term confusion are very rare. In such cases, the administered dose should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioneurotic edema, and skin redness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product 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 through the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua

Shelf life. 4 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibilities. Do not mix with other medicinal products in the same container.

Packaging. 4 mL in a vial, 3 vials in a blister pack; 1 blister pack in a cardboard box.

Prescription status. Prescription only.

Manufacturer. K.T. Rompharm Company S.R.L. / S.C. Rompharm Company S.R.L.

Manufacturer's address and location of its business operations

Str. Eroilor No. 1A, Otopeni, 075100, Ilfov County, Romania – Rompharm 1 and Rompharm 2 buildings.

Marketing Authorization Holder. LLC "BFC "SALUTARIS".

Address of the Marketing Authorization Holder. 9, Druzhby Narodiv Boulevard, Kyiv, 01042, Ukraine.