Halcerate^® (Solution) Instructions for Use

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Halcerate®

Oral solution 600 mg/7 ml: bottle 7 ml, 70 ml or 100 ml

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless.

* calculated as 100% substance.

Excipients: methylparaben – 8 mg, propylparaben – 2.4 mg, purified water – up to 7 ml.

7 ml – brown glass bottles (10) – cardboard packs.
70 ml – brown glass bottles (1) with a measuring cup – cardboard packs.
100 ml – brown glass bottles (1) with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Cholinomimetic. It is a precursor of acetylcholine. It acts primarily on cholinergic receptors in the CNS. Glycerophosphate, which is formed during the breakdown of choline alfoscerate, is a precursor of neuronal membrane phospholipids (phosphatidylcholine). It facilitates the transmission of nerve impulses in cholinergic neurons, improves the plasticity of neuronal membranes and receptor function.

Pharmacokinetics

After oral administration, an average of about 88% of the choline alfoscerate dose is absorbed, with rapid distribution in organs and tissues. It penetrates the BBB. It accumulates mainly in the brain (the concentration in the brain reaches 45% of that in plasma), lungs and liver. 85% is excreted by the lungs as carbon dioxide, the remaining amount (15%) is excreted through the kidneys and through the intestines.

Indications

Cerebral circulation disorders of the ischemic type (acute and recovery period) and hemorrhagic type (recovery period); psychoorganic syndrome against the background of involutional and degenerative processes of the brain; consequences of cerebrovascular insufficiency or primary and secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased concentration; behavioral and affective disorders in old age – emotional lability, increased irritability, decreased interest; senile pseudomelancholy; multi-infarct dementia.

ICD codes

Dosage Regimen

Administer orally, intramuscularly, or intravenously as directed.

Set the dosage regimen individually based on the indication, clinical presentation, disease characteristics, and patient tolerance.

For oral administration, use the provided measuring cup to ensure accurate dosing.

For acute conditions, initiate therapy with a higher dose, adjusting based on clinical response.

For chronic conditions and maintenance therapy, use a lower, sustained dose.

Administer the oral solution directly from the measuring cup; do not mix with other liquids.

The typical adult oral dose is one 7 ml solution (600 mg) taken once or twice daily.

For intramuscular or intravenous administration, follow the prepared solution’s instructions for use exactly.

Do not exceed the maximum recommended daily dose unless directed by a physician.

If nausea occurs, which may result from dopaminergic activation, reduce the dose.

Regularly assess patient response and adjust the dosage accordingly during long-term treatment.

Discontinue use if severe adverse reactions occur and seek medical advice.

Adverse Reactions

From the digestive system: nausea, abdominal pain.

From the nervous system: short-term confusion.

Contraindications

Hypersensitivity to choline alfoscerate; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

Nausea may be a consequence of dopaminergic activation. If nausea occurs, the dose of choline alfoscerate should be reduced.

Effect on the ability to drive vehicles and machinery

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.