Citicoline-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CYTICOLINE-ZDOROVYE (CITICOLINE-ZDOROVYE)

Composition:

Active substance: citicoline;

1 ml of the preparation contains 100 mg of citicoline;

Excipients: sorbitol (E 420); glycerol; methylparaben (E 218); propylparaben (E 216); sodium saccharin; sodium citrate; potassium sorbate; citric acid; purified water; "Strawberry" flavor containing propylene glycol, flavoring substances (natural and nature-identical).

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents. ATC code N06BX06.

Pharmacological properties.

Pharmacodynamics. Cytidine 5'-diphosphocholine (citicoline) stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline improves the function of membrane mechanisms such as ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction.

Thanks to its membrane-stabilizing effect, citicoline exhibits anti-edematous properties that contribute to the reduction of cerebral edema.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline maintains neuronal energy reserves, inhibits apoptosis, and stimulates acetylcholine synthesis.

It has been demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

It is known that citicoline significantly enhances functional recovery in patients with acute ischemic stroke, which correlates with a slowing of the growth in volume of ischemic brain damage as shown by neuroimaging.

In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, as well as cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics. Citicoline is almost completely absorbed after oral administration. Following administration, a significant increase in plasma choline levels is observed.

The drug is metabolized in the intestine and liver, forming choline and cytidine.

After administration, citicoline is widely distributed in brain structures, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. In the brain, citicoline integrates into cellular, cytoplasmic, and mitochondrial membranes, becoming part of the phospholipid fraction.

Only a small amount of the dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. Renal excretion of the drug occurs in two phases: the first phase lasts 36 hours, during which the excretion rate decreases rapidly, and the second phase, during which the excretion rate declines much more slowly. The same biphasic pattern is observed in excretion via the respiratory tract. The rate of elimination as CO₂ decreases rapidly within approximately 15 hours, then declines much more slowly thereafter.

Clinical characteristics.

Indications.

• Stroke, acute phase of cerebral circulation disorders and treatment of complications and consequences of cerebral circulation disorders.
• Traumatic brain injury and its neurological consequences.
• Cognitive disorders and behavioral disturbances due to chronic vascular and degenerative cerebral disorders.

Contraindications.

• Hypersensitivity to citicoline or to other components of the medicinal product.
• Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other forms of interaction.
Citicoline enhances the effect of levodopa. The drug should not be administered simultaneously with medicinal products containing meclofenoxate.

Special precautions for use

. If a patient has known intolerance to certain sugars, a physician should be consulted before taking this medicinal product.

May cause allergic reactions (possibly delayed).

This medicinal product contains 31.67 mg/1.377 mmol of sodium per 500 mg (5 ml) dose of citicoline. Caution is advised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding. Adequate data on the use of citicoline in pregnant women are lacking. Data on the excretion of citicoline in breast milk and its effects on the fetus are unknown. During pregnancy or breastfeeding, this medicinal product should be administered only if the expected therapeutic benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery. In individual cases, certain adverse reactions affecting the central nervous system may impair the ability to drive or operate complex machinery.

Method of Administration and Dosage

For oral use. The recommended dose of the medicinal product for adults is from 500 mg (5 mL) to 2000 mg (20 mL) per day, divided into 2–3 doses, depending on the severity of symptoms.

The dose should be measured using a graduated measuring cup or a dosing syringe.

Administration using a dosing syringe:

• Before use, fully press the plunger of the dosing syringe.
• Pull back the plunger and draw the required dose, ensuring that the volume of liquid in the dosing syringe corresponds to the prescribed dose.
• The medication may be taken directly or diluted in half a glass of water (120 mL), regardless of

meals.

The dosing syringe must be rinsed with water after each use.

The recommended dose of the medicinal product is 10–20 mL (or 1–2 sachets) per day, depending on the severity of the disease. The medication may be taken directly from the bottle (or directly from the sachet) or diluted in half a glass of water (120 mL), regardless of meals.

Dosage and duration of treatment depend on the severity of brain lesions and are determined individually by the physician.

Elderly patients do not require dose adjustment.

Children. Experience with the use of the medicinal product in children is limited.

Overdose. Cases of overdose have not been reported.

Adverse Reactions

Adverse reactions occur very rarely (<1/10,000), including isolated cases.

Psychiatric disorders: hallucinations.

Nervous system disorders: severe headache, vertigo.

Cardiovascular disorders: arterial hypertension, arterial hypotension.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, occasional diarrhea.

Skin and subcutaneous tissue disorders: rash, hyperemia, exanthema, purpura.

General disorders: chills, edema.

Reporting of 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. Healthcare professionals, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance 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.

Do not freeze.

Keep out of reach and sight of children.

Slight opalescence may occur during storage, which disappears when the preparation is kept at room temperature (approximately 25 °C).

Packaging. 30 ml, 50 ml, or 100 ml in a bottle with a measuring cup in a carton; 50 ml or 100 ml in a bottle with a dosing syringe-pipette in a carton; 10 ml in sachet №20 in a carton.

Prescription status. Prescription only.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovia".

Manufacturer's address and location of operations. 22, Shevchenko Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.