Cereton^® (Alpha-GPC) Instruction

International Non-Proprietary Name (INN): choline alfoscerate
Dosage form: capsules
Structure
In 1 capsule:
Active ingredient: choline alphoscerate (calculation for 100% substance) 400 mg;
Excipients: glycerol, purified water;
Capsules composition: gelatine, sorbitol, glycerol, methylparahydroxybenzoate, propyl parahydroxybenzoate, titanium dioxide, iron oxide yellow, purified water.
Description
Soft, gelatine, oval capsules of yellow or yellow with a light brown colour. Capsule composition: oily, clear, colourless or slightly coloured liquid.
Pharmacological classification: nootropics
ATC code: N07AX02
Pharmacological action: nootropic

Pharmacodynamics

Nootropic medicine. Central cholinostimulator, which contains 40.5% of metabolically protected choline. Metabolic protection facilitates the release of choline in the brain. Provides the synthesis of acetylcholine and phosphatidylcholine in neuronal membranes, improves the blood flow and enhances metabolic processes in the central nervous system, activates reticular formation. Increases the linear velocity of blood flow on the side of a traumatic brain injury, promotes normalization of spatiotemporal characteristics of spontaneous bioelectric activity of the brain, regression of local neurological symptoms and restoration of consciousness; has a positive effect on the cognitive and behavioural responses of patients with cerebrovascular diseases (discirculatory encephalopathy and residual effects of cerebral circulation disorders). Provides a preventive and corrective effect on the pathogenetic factors of the involutional psychoorganic syndrome, changes the phospholipid composition of neuronal membranes; participates in the synthesis of phosphotidylcholine (membrane phospholipid); improves the plasticity of neuronal membranes. Stimulates dose-dependent ejection of acetylcholine under physiological conditions, improves the synaptic transmission and receptors function. Does not affect the reproductive cycle and does not have a teratogenic, mutagenic effect.

Pharmacokinetics

In parenteral administration (10 mg/kg), Cereton^® mainly accumulates in the brain, lungs and liver. Absorption is 88%. Easily penetrates through the blood-brain barrier (in oral intake, the concentration in the brain is 45% of that in the plasma), 85% of the medicine is excreted by the lungs in the form of carbon dioxide, the rest (15%) is excreted by the kidneys and through the intestine.

Intended uses

• the recovery period after a severe craniocerebral injury and an ischemic stroke, the recovery period after a hemorrhagic stroke, with local hemispheric symptoms or symptoms of brainstem lesion;
• psychoorganic syndrome against the degenerative and involuntary changes in the brain;
• cognitive disorders (impaired mental and memory function, confusion, disorientation, decreased motivation, initiative and ability to concentrate), including cases of dementia and encephalopathy;
• senile pseudo melancholia.

Contraindications

• hypersensitivity to the medicine;
• acute stage of hemorrhagic stroke;
• pregnancy;
• breastfeeding;
• age under 18 years old (due to the lack of data).

Dosage and administration

Per os.

In the recovery period of craniocerebral injury, ischemic or hemorrhagic stroke
Preparation is prescribed at the dose of 800 mg in the morning and 400 mg in the afternoon for 6 months.

Chronic cerebrovascular insufficiency and dementia syndromes
The dose is 400 mg (1 caps) 3 times a day, preferably after meals, for 3–6 months.

Side effects

Nausea is possible (mainly because of dopaminergic activation). Cancellation of the treatment is not required; the dosage should be reduced. Allergic reactions are possible.

Overdose

Symptoms
Nausea.

Treatment
Symptomatic therapy.

Interaction with other drugs

No significant interaction with other medicines has been identified.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Influence on the ability to drive vehicles and operate mechanisms

Cereton^® does not affect the speed of psychomotor reactions.

Terms of release from pharmacy

On prescription.

Storage conditions

At a temperature of no higher than 25°C. Keep out of the reach of children.

Shelf life

3 years. Do not use beyond the expiration date printed on the package.

Manufacturer

Sotex Farm, Russia. https://www.sotex.ru/