Quanil

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

Composition:

Active substance: citicoline sodium (citidine diphosphate choline);

1 sachet (1.5 g of granules) contains citicoline sodium equivalent to 500 mg of citicoline;

Excipients: sorbitol (E 420), povidone, anhydrous citric acid, aspartame (E 951), "Lemon Premium" flavor, polyethylene glycols 6000, sodium stearyl fumarate, sodium lauryl sulfate.

Pharmaceutical form. Granules.

Main physicochemical properties: white or almost white granules with a lemon flavor.

Pharmacotherapeutic group.

Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents. 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 enhances the function of ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Thanks to its stabilizing effect on neuronal membranes, citicoline accelerates reabsorption of brain edema, thus exhibiting anti-edematous properties.

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 improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Citicoline significantly improves functional recovery parameters in patients with acute ischemic cerebrovascular disorders, slowing the progression of ischemic brain tissue damage as shown by neuroimaging data.

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

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

Pharmacokinetics.

Citicoline is well absorbed after oral administration. After drug intake, a significant increase in plasma choline levels is observed. Following oral administration, the drug is almost completely absorbed. Bioavailability via oral and parenteral routes is nearly equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissues, where choline acts on phospholipids and cytidine acts on cytidine nucleosides and nucleic acids. Citicoline rapidly reaches brain tissue and actively incorporates into cell membranes, cytoplasm, and mitochondria, activating phospholipid activity.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination of the drug in urine and via the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours, via respiratory tract—within the first 15 hours), the second phase—slow elimination.

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 disorders due to chronic vascular and degenerative cerebral disorders.

Contraindications.

-Hypersensitivity to citicoline or to any of the other components of the drug.

-Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other types 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 a known intolerance to certain sugars, consult a physician before taking this medicinal product, as the preparation contains sorbitol (E 420).

The medicinal product contains aspartame (E 951), a phenylalanine derivative, which may be harmful to patients with phenylketonuria.

The medicinal product contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding

There are insufficient data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy unless clearly necessary. During pregnancy or breastfeeding, the medicinal product should be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant. Data on the passage of citicoline into breast milk and its effects on the infant are lacking.

Ability to affect reaction rate when driving or operating machinery

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

Method of administration and dosage.

The Quanil preparation should be taken orally, after dissolving the granules in half a glass of water, regardless of food intake.

The recommended dose for adults is from 500 mg (1 sachet) to 2000 mg (4 sachets) per day.

The dosage and duration of treatment depend on the severity of brain lesions and are determined individually by a 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.

From the nervous system: hallucinations, excitement, insomnia.

From the nervous system: severe headache, dizziness, tremor.

From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

From the respiratory system: dyspnea (shortness of breath).

From the gastrointestinal tract: nausea, vomiting, stomach pain, hypersalivation, slight changes in liver function parameters, occasional diarrhea.

From the immune system: allergic reactions, including rash, itching, angioedema, anaphylactic shock, redness, urticaria, exanthema, purpura.

General disorders: chills, increased body temperature, feeling of warmth, swelling.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

1.5 g in sachets №1, 10 or 30 sachets per cardboard pack.

Prescription status.

Prescription only.

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and location of business activity.

SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.