Cereton^® (Capsules, Solution) Instructions for Use

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; parasympathomimetics; other parasympathomimetics

Pharmacological Action

Pharmacodynamics

Cereton^® is Choline alfoscerate, which is a central-acting cholinomimetic with a predominant effect on the central nervous system.

The drug contains 40.5% choline, which is released from the compound in the brain; choline is involved in the biosynthesis of acetylcholine (one of the main neurotransmitters of nerve excitation). Alfoscerate is biotransformed to glycerophosphate, which is a precursor of phospholipids.

Acetylcholine has a positive effect on the transmission of nerve impulses, and glycerophosphate is involved in the synthesis of phosphatidylcholine (a membrane phospholipid), resulting in improved membrane elasticity and receptor function.

Cereton^® enhances metabolic processes and activates the structures of the brain’s reticular formation.

It has a preventive and corrective effect on the factors of involutional psychoorganic syndrome, such as changes in the phospholipid composition of neuronal membranes and decreased cholinergic activity.

Pharmacodynamic studies have shown that Cereton^® acts on synaptic, including cholinergic, nerve impulse transmission (neurotransmission), neuronal membrane plasticity, and receptor function.

Pharmacokinetics

Absorption

Absorption after oral administration is 88%; it easily penetrates the blood-brain barrier.

Distribution

It accumulates mainly in the brain (the concentration in the brain reaches 45% of the level in the blood plasma), lungs, and liver.

Elimination

85% of choline alfoscerate is eliminated by the lungs as carbon dioxide, the remaining amount (15%) is eliminated by the kidneys and through the intestines.

Indications

Use in adults

• Cerebrovascular disorders of the ischemic type (acute and recovery periods) 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, and decreased concentration.
• Behavioral and affective disorders in old age: emotional lability, increased irritability, decreased interest; senile pseudomelancholia.
• Multi-infarct dementia.

Use in children and adolescents aged 11 to 18 years

• Mild to moderate cognitive impairments due to traumatic brain injury and/or hemorrhagic stroke (including the recovery period and long-term consequences of the above conditions).

ICD codes

Dosage Regimen

Capsules

Orally, before meals, with water.

Adults

1 capsule (400 mg) 2-3 times/day. The duration of treatment is determined individually by the doctor depending on the clinical picture and characteristics of the disease, age and drug tolerance.

Children and adolescents

Mild to moderate cognitive impairments due to traumatic brain injury or hemorrhagic stroke

Patients aged 11-15 years: 1 capsule (400 mg) 2 times/day (in the morning and in the afternoon).

Patients aged 16-17 years: 2 capsules (800 mg) in the morning and 1 capsule (400 mg) in the afternoon.

The duration of treatment is determined individually by the doctor depending on the clinical picture and characteristics of the disease. The course of treatment is up to 60 days.

The safety and efficacy of Cereton^® in children aged 11 to 18 years for other indications have not been established to date. Data are not available.

Solution

Take orally, before meals, with water.

If a dosing device is not included in the package, it is recommended to use a 2, 3, or 5 ml medical syringe for dosing the drug.

Adults

600 mg (5 ml) 2 times/day. The duration of treatment is determined individually by the doctor depending on the clinical picture and characteristics of the disease, age and drug tolerance.

Children

Mild to moderate cognitive impairments, including in the recovery period of traumatic brain injury and/or hemorrhagic stroke

Patients aged 6-10 years – 200 mg (1.6 ml) 1 time/day.

Patients aged 11-15 years – 400 mg (3.3 ml) 2 times/day (in the morning and in the afternoon).

Patients aged 16-17 years – 800 mg (6.6 ml) in the morning and 400 mg (3.3 ml) in the afternoon.

For patients over 11 years of age, the drug can be taken in the form of 400 mg capsules.

The duration of treatment is determined individually by the doctor depending on the clinical picture and characteristics of the disease. The course of treatment is up to 60 days.

Adverse Reactions

Gastrointestinal disorders nausea (which is mainly a consequence of secondary dopaminergic activation), abdominal pain.

Psychiatric disorders short-term confusion (in this case, it is necessary to reduce the dose of the drug).

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

Contraindications

• Hypersensitivity to choline alfoscerate and/or to any excipient of the drug.
• Pregnancy.
• Breastfeeding period.
• Children under 11 years of age when used for the indication: mild to moderate cognitive impairments due to traumatic brain injury or hemorrhagic stroke.
• Children under 18 years of age when used for other indications.

Use in Pregnancy and Lactation

The use of Cereton^® during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated in children under 11 years of age (for this dosage form) when used for the indication: mild to moderate cognitive impairments due to traumatic brain injury or hemorrhagic stroke.

Contraindicated in children and adolescents under 18 years of age when used for other indications (due to lack of data on efficacy and safety).

Geriatric Use

Use is possible according to the dosing regimen.

Special Precautions

Nausea may be a consequence of dopaminergic activation when taking the drug (see section “Adverse Reactions”).

Excipients

Sorbitol

Patients with rare hereditary fructose intolerance should not take this drug.

Propylparahydroxybenzoate and Methylparahydroxybenzoate

This drug contains parahydroxybenzoates in the form of propyl and methyl esters, which can cause allergic reactions (including delayed ones).

Glycerol

May cause headache, stomach upset and diarrhea.

Effect on ability to drive vehicles and operate machinery

During treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: nausea.

It is possible to increase the severity of dose-dependent adverse effects.

Treatment symptomatic therapy. The effectiveness of dialysis has not been established.

Drug Interactions

Interaction studies have not been conducted.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.