KVANIL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT QUANIL (QUANILÒ)

Composition:

Active substance: citicoline;

1 ml of solution contains sodium citicollinate equivalent to citicoline 100 mg;

Excipients: sorbitol solution (E 420), glycerol, sodium methylparahydroxybenzoate (E 219), sodium propylparahydroxybenzoate (E 217), propylene glycol, sodium citrate, sodium saccharin, potassium sorbate, strawberry flavoring, anhydrous citric acid, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Other psychostimulants and nootropics. ATC code N06BX06.

Pharmacological Properties.

Pharmacodynamics.

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 transmission. Thanks to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties that contribute to a reduction in cerebral edema.

Experimental studies have shown that 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 experimentally proven that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Clinical studies have shown that citicoline significantly enhances functional recovery in patients with acute ischemic stroke, which correlates with a slowing of the growth of the ischemic brain lesion volume as demonstrated 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 disorders associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics.

Citicoline is almost completely absorbed after oral administration. After 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 incorporated into the phospholipid fraction structure.

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

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 drug.
• Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other forms of interactions.

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, consult a physician before taking this medicinal product, as the preparation contains sorbitol solution. Propylparahydroxybenzoate sodium (E 217) and methylparahydroxybenzoate sodium (E 219), contained in the preparation, may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

There is insufficient data on the use of citicoline in pregnant women. Data regarding excretion of citicoline in breast milk and its effects on the fetus are unknown. During pregnancy or breastfeeding, the drug should be administered only when the expected therapeutic benefit to the mother outweighs the potential risk to the fetus.

Ability to influence reaction rate when driving or operating machinery.

In individual cases, certain adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.

Method of Administration and Dosage

Quanil should be administered orally, regardless of food intake.

The recommended dose for adults is 500 mg (5 mL) to 2000 mg (20 mL) daily, divided into 2–3 doses depending on the severity of symptoms.

The medication should be mixed with a small amount of water before administration and taken using a measuring cup. The measuring cup should be rinsed with water after each use. A disposable plastic syringe (without needle) may be used for accurate dose measurement.

Drug 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 drug in children is limited.

Overdose.

Cases of overdose have not been reported.

Side effects.

Central nervous system: severe headache, vertigo, hallucinations.

Cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system: dyspnea.

Gastrointestinal tract: nausea, vomiting, diarrhea.

Immune system: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioneurotic edema, anaphylactic shock.

General reactions: chills.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze or cool. Slight opalescence may occur during storage, which disappears when the preparation is kept at room temperature (≈ 20 °C). Keep out of reach of children.

Packaging.

30 ml or 100 ml in bottles No. 1. Each bottle in a cardboard pack with a measuring cup.

Prescription status.

Prescription only.

Manufacturer.

LLC "KUSUM PHARM".

Manufacturer's location and address of business activity.

40020, Ukraine, Sumy region, city of Sumy, Skryabina St., 54.

or

Manufacturer.

LLC "GLEDPHARM LTD".

Manufacturer's location and address of business activity.

40020, Ukraine, Sumy region, city of Sumy, Davydovskoho Hryhoriia St., 54.