Ronocyt

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RONOCIT (RONOCIT)

Composition:

Active substance: citicoline;

1 ml of solution contains citicoline (in the form of citicoline sodium) 100 mg;

Excipients: sorbitol solution, non-crystallizing (E 420); glycine; methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E 216); sodium citrate dihydrate; sodium saccharin; strawberry flavoring; potassium sorbate; citric acid monohydrate; purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: homogeneous clear 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

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.

Due to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties, which 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 free radical formation, 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.

Experimental evidence has demonstrated 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 in volume of ischemic brain damage 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 deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

After oral administration, citicoline is almost completely absorbed. Following intake, a significant increase in plasma choline levels is observed.

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

After administration, it is widely distributed into 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 negligible amount of the dose is found in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. During urinary excretion of citicoline, two phases are observed: in the first phase, lasting up to 36 hours, the excretion rate decreases rapidly; in the second phase, 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, within approximately 15 hours, and then decreases 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 the active substance and/or to any of the excipients of the medicinal product.
• Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other types of interactions.

Citicoline enhances the effect of levodopa.

Citicoline should not be used concomitantly with medicinal products containing meclofenoxate.

Special precautions for use

The medicinal product contains sorbitol and therefore should not be used in patients with hereditary fructose intolerance.

Methylparahydroxybenzoate and propylparahydroxybenzoate contained in the medicinal product may cause allergic reactions (usually of the delayed type).

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

Use during pregnancy or breastfeeding

There are insufficient data on the use of citicoline in pregnant women. Data on the excretion of citicoline in breast milk and its effects on the fetus are lacking. During pregnancy or breastfeeding, the medicinal product should be used only if the expected therapeutic benefit for the mother outweighs the potential risk to the fetus/infant.

Ability to affect reaction speed when driving or operating machinery

In individual cases, some adverse reactions related to the central nervous system may affect the ability to drive or operate machinery.

Dosage and Administration.

The medicinal product is intended for oral use. The solution can be taken directly from the bottle or diluted in half a glass of water (120 ml), regardless of food intake.

The recommended dose 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.

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.

There have been no reports of citicoline overdose.

Side effects.

Side effects occur very rarely (<1/10,000), including isolated cases.

Nervous system disorders:

severe headache, vertigo, hallucinations.

Cardiovascular system disorders:

arterial hypertension, arterial hypotension, tachycardia.

Respiratory, thoracic and mediastinal disorders:

dyspnea.

Gastrointestinal disorders:

nausea, vomiting, diarrhea.

Immune system disorders:

allergic reactions, including: rash, hyperemia, exanthema, purpura.

General disorders:

chills, edema.

Reporting of suspected side effects

Reporting of suspected side effects occurring after marketing authorization of the medicinal product is very important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life.

5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging.

10 ml in a vial; 10 vials in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

UORLД MEDICINE ILAC SAN. VE TIDJ. A.S./
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and place of business.

COSB G.O.Pasa Mah. 6. Cad. No:30, Cerkezkoy/Tekirdag, Turkey.

Marketing Authorization Holder.

LLC "WORLD MEDICINE", Ukraine/
WORLD MEDICINE, LLC, Ukraine.