Noocil^® (Solution) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Contact Information

OZON LLC (Russia)

ATC Code

N06BX06 (Citicoline)

Active Substance

Citicoline (Rec.INN registered by WHO)

Dosage Form

Noocil®

Oral solution 100 mg/1 ml: 10 ml fl. 10 pcs.; 240 ml fl. 1 pcs.

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless or slightly yellowish, with a characteristic odor.

Excipients : sorbitol – 200 mg, glycerol – 50 mg, sodium citrate – 6 mg, potassium sorbate – 3 mg, methylparaben – 1.45 mg, citric acid – 1 mg, strawberry flavor – 0.41 mg, propylparaben – 0.25 mg, sodium saccharin – 0.2 mg, purified water – up to 1 ml.

10 ml – bottles of colorless glass (10) – cardboard boxes.
240 ml – bottles of dark glass (1) complete with a dosing syringe – cardboard boxes.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a broad spectrum of action – it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by acting on apoptosis mechanisms. In the acute period of stroke, Citicoline reduces the volume of brain tissue damage and improves cholinergic transmission.

In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, and also helps to shorten the duration of the recovery period.

In chronic cerebral hypoxia, Citicoline is effective in the treatment of cognitive disorders, such as memory impairment, lack of initiative, difficulties in performing daily activities and self-care. It increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

Citicoline is used in the therapy of sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics

Absorption

Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration.

Distribution

Citicoline is largely distributed in the structures of the brain, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated into cellular, cytoplasmic, and mitochondrial membranes, participating in the construction of the phospholipid fraction.

Metabolism

The drug is metabolized in the intestine and liver to form choline and cytidine. After administration, the plasma concentration of choline increases significantly.

Excretion

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% – by the kidneys and through the intestines, and about 12% – with exhaled CO₂.

Two phases can be distinguished in the urinary excretion of citicoline: the first phase, lasting about 36 hours, during which the excretion rate decreases rapidly, and the second phase, during which the excretion rate decreases much more slowly. The same is observed in exhaled CO₂ – the excretion rate decreases rapidly after approximately 15 hours, and then decreases much more slowly.

Indications

• Acute period of ischemic stroke (cerebral infarction) (as part of complex therapy);
• Recovery period of ischemic and hemorrhagic stroke;
• Traumatic brain injury (TBI): acute (as part of complex therapy) and recovery period;
• Cognitive and behavioral disorders in degenerative and vascular brain diseases.

ICD codes

Dosage Regimen

The drug is taken orally, during meals or between meals. Before use, the solution can be diluted in a small amount of water (120 ml or 1/2 cup).

Acute period of ischemic stroke and traumatic brain injury (TBI) 1000 mg (10 ml) every 12 hours. The duration of treatment is at least 6 weeks.

Recovery period of ischemic and hemorrhagic strokes, recovery period of TBI, cognitive and behavioral disorders in degenerative and vascular brain diseases 500-2000 mg/day (5-10 ml 1-2 times/day). The dose and duration of treatment are determined depending on the severity of the disease symptoms.

When prescribing the drug to elderly patients, dose adjustment is not required.

Adverse Reactions

Adverse events are grouped by system and organ in accordance with the MedDRA dictionary and the WHO classification of adverse event frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); frequency not known (frequency cannot be estimated from the available data).

Nervous system disorders very rare – headache, dizziness, parasympathetic system reactions, tremor, numbness in paralyzed limbs.

Psychiatric disorders very rare – hallucinations, insomnia, agitation.

Vascular disorders very rare – arterial hypotension, arterial hypertension.

Respiratory, thoracic and mediastinal disorders very rare – dyspnea.

Gastrointestinal disorders very rare – decreased appetite, nausea, vomiting, diarrhea.

Hepatobiliary disorders very rare – change in liver enzyme activity.

Skin and subcutaneous tissue disorders very rare – hyperemia, purpura, anaphylactic shock, urticaria, rash, skin itching.

General disorders and administration site conditions very rare – chills, feeling of heat, edema.

If any of the side effects mentioned in the instructions get worse, or if you notice any other side effects not listed in the instructions, the patient should inform the doctor.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Patients with pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
• Children and adolescents under 18 years of age (due to the lack of sufficient clinical data).

Use in Pregnancy and Lactation

Sufficient data on the use of citicoline in pregnant women are not available. Although no negative effects have been identified in animal studies, the drug is prescribed during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When prescribing the drug during lactation, women should stop breastfeeding, since data on the excretion of citicoline in breast milk are not available, and the risk to the child cannot be completely excluded.

Pediatric Use

The use of the drug is contraindicated in patients under 18 years of age.

Geriatric Use

When prescribing the drug to elderly patients, dose adjustment is not required.

Special Precautions

When cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. When stored further under recommended conditions, the crystals dissolve within a few months. The presence of crystals does not affect the quality of the drug.

Effect on ability to drive vehicles and operate machinery

During treatment, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Overdose

Given the low toxicity of the drug, cases of overdose have not been described.

In case of accidental overdose – symptomatic treatment.

Drug Interactions

Citicoline enhances the effects of levodopa.

It should not be used simultaneously with medicines containing meclofenoxate.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Shelf life for an opened 240 ml bottle – no more than 30 days after opening.

Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.