NOOHOLIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOOCHOLINE

Composition:

Active substance: choline alfoscerate;

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

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

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

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

Pharmacological Properties.

Pharmacodynamics.

Choline alfoscerate is an agent 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 formulation contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Choline alfoscerate exerts a positive effect on memory functions and cognitive abilities, as well as on emotional state and behavioral parameters, which are impaired due to the development of brain involutional pathology.

The mechanism of action is based on the fact that after entering the body, choline alfoscerate is enzymatically hydrolyzed into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the major mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, choline alfoscerate enhances nerve impulse transmission in cholinergic neurons, exerts a positive influence on neuronal membrane plasticity and receptor function. Choline alfoscerate improves cerebral circulation, 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 dose of choline alfoscerate is absorbed. The drug accumulates predominantly in the brain (45% of the drug concentration in blood), 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 (disturbance of consciousness, coma, focal hemispheric symptoms, signs of brainstem injury).

Degenerative-involutional cerebral psycho-organic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive impairments in elderly individuals characterized by memory disturbances, 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 the medicinal product or its components.

Psychotic syndrome, 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.

Instructions for use.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

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

Administration and Dosage

In acute conditions, Nooholin should be administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) daily for 15–20 days. After stabilization of the patient's condition, switch to the capsule form of the drug.

Children.

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

Overdose.

In case of Nooholin overdose, which may manifest as nausea, restlessness, excitement, and insomnia, the dose should be reduced. Symptomatic therapy is recommended.

Adverse reactions.

The medicinal product is generally well tolerated, even during prolonged 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 (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, and very rarely abdominal pain and short-term confusion may occur. In such cases, the administered dose of the medicinal product should be reduced.

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

Reporting of suspected adverse reactions.

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system (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.

Incompatibility.

The medicinal product must not be mixed with other medicinal products in the same container.

Packaging.

4 ml in a vial, 3 or 5 vials in a blister pack within 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 place of business.

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

Marketing Authorization Holder.

FORC-FARMA DISTRIBUTION LLC.

Address of the Marketing Authorization Holder.

132, Holosiivske Avenue, Kyiv, 03127, Ukraine.