Cereglia®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CEREGLIA® (CEREGLIA)

Composition:

Active substance: choline alfoscerate;

1 capsule contains choline alfoscerate 400 mg;

Excipients: glycerol, purified water;

capsule shell: gelatin, sorbitol liquid partially dehydrated, glycerol, sodium methylparahydroxybenzoate (E 219), sodium propylparahydroxybenzoate (E 217), titanium dioxide (E 171), yellow iron oxide (E 172).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft oval-shaped gelatin capsules with a seam, opaque, light yellow-brown in color. The capsule contents — a clear colorless or slightly yellowish viscous liquid.

Pharmacotherapeutic group. Agents acting on the nervous system.

Parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Cereglia® 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 can 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. Cereglia® exerts a positive effect on memory functions and cognitive abilities, as well as on parameters of emotional state and behavior, which are 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 hydrolyzed by enzymes 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, Cereglia® improves nerve impulse transmission in cholinergic neurons; positively affects neuronal membrane plasticity and receptor function. Cereglia® enhances cerebral blood flow, intensifies metabolic processes in the brain, activates structures of the brain's reticular formation, and restores consciousness following traumatic brain injury.

Pharmacokinetics.

On average, approximately 88% of the administered dose is absorbed. The drug accumulates predominantly in the brain (45% of the drug concentration in blood), lungs, and liver. Elimination occurs primarily via the lungs in the form of carbon dioxide (CO₂). Only 15% of the drug is excreted in urine and bile.

Clinical characteristics.

Indications.

Degenerative-involutional cerebral psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive impairments in elderly individuals characterized by memory disturbances, mental confusion, disorientation, reduced motivation and initiative, and impaired concentration ability; changes in emotional and behavioral spheres: emotional instability, irritability, indifference towards the environment; pseudomelancholia in elderly individuals.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Psychotic syndrome, severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interactions.

Clinically significant interaction of the drug with other medicinal products has not been established.

Special precautions for use.

If a patient has known intolerance to certain sugars, consult a physician before using this medicinal product.

Use during pregnancy or breastfeeding.

This medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration

The medicinal product should be used only in adults.

Take 1 capsule 2 or 3 times daily.

The duration of treatment is determined individually by a physician.

Children. There is no experience with the use of the medicinal product in children.

Overdose.

In case of overdose of the medicinal product Cereglia®, which may manifest as nausea, restlessness, excitement, and insomnia, the dose should be reduced.

Symptomatic therapy.

Adverse reactions.

The medicinal product is generally well tolerated, even with long-term use.

During the first days or weeks of treatment, the following adverse reactions may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be considered.

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 dose of the medicinal product should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioedema, and skin redness. Cereglia® may cause allergic reactions (including delayed-type reactions).

Reporting of suspected adverse reactions

Reporting of adverse reactions after medicinal product registration 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 at the following link: https://aisf.dec.gov.ua

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 capsules per blister; 1 or 3 blisters per carton.

Prescription status. Prescription only.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business activity.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.