Encefacolin ® Neo – oral solution

INSTRUCTIONS FOR MEDICAL USE

ENCEFACOLIN® NEO

Trade name of drug: Encefacolin® Neo

Active substance (INN): Citicoline

Pharmaceutical form: oral solution.

Contents:

100 ml of the solution contains:

Active substance: citicoline sodium – 10.45 g;

Excipients: sorbitol 70%, glycerin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium citrate, sodium saccharine, strawberry flavoring, potassium sorbate, citric acid, purified water up to 100 ml.

Description: colorless or yellowish transparent liquid, with a smell of strawberries.

Pharmacotherapeutic group: nootropic agents.

ATX code: N06BX06

Pharmacological properties

Citicoline, being a precursor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a broad spectrum of action: it helps restore the damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals and also prevents cell death by influencing the apoptosis mechanism. In the acute period of stroke citicoline reduces the volume of brain tissue damage, improves cholinergic transmission. In craniocerebral trauma reduces the duration of post-traumatic coma and severity of neurological symptoms, in addition, contributes to reducing the duration of the recovery period. In chronic cerebral hypoxia citicoline is effective in treating 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 reduces the manifestation of amnesia. Citicoline is effective in treatment 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.

Metabolism

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

Distribution

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

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.

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

Indications for use

  • Acute period of ischemic stroke (as part of complex therapy).
  • The recovery period of ischemic and hemorrhagic strokes.
  • Craniocerebral trauma (CTS), acute (as part of complex therapy) and recovery period.
  • Cognitive, sensory, motor and neuropsychological disorders associated with cerebral pathology of degenerative or vascular origin.

Directions for use and dosages

The drug is prescribed orally. Before using, the drug may be diluted in a small amount of water (120 ml or 1/2 cup). Taken with a meal or between meals. Recommended dosage regimen

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

Recovery period of ischemic and hemorrhagic strokes, the recovery period of CHT, cognitive and behavioral disorders in degenerative and vascular brain diseases: 500-2000 mg (5-10 ml) 1-2 times a day. Dosage and duration of treatment depending on the severity of the symptoms.

Elderly patients

No dosage adjustment is required when prescribing the drug in elderly patients.

Side effects

Frequency of side effects

Very rare (<1/10000) (including individual cases):

Allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, fever, tremor, nausea, vomiting, diarrhea, hallucinations, edema, dyspnea, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, changes in liver enzyme activity. In some cases, the drug may stimulate the parasympathetic system, as well as have short-term changes in blood pressure.

If any of the side effects specified in the instructions are aggravated, or any other side effects not specified in the instructions have been noticed, you should inform your doctor.

Contraindications

  • Hypersensitivity to any of the ingredients
  • Severe vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
  • rare hereditary diseases associated with fructose intolerance;

Drug interactions

Citicoline enhances the effects of levodopa. Should not be administered concomitantly with drugs containing meclofenoxate.

Special Indications

A small amount of crystals may form in the cold due to temporary partial crystallization of the preservative. Upon further storage under the recommended conditions, the crystals will dissolve within several months. The presence of crystals does not affect the quality of the drug. During treatment, caution should be exercised when performing potentially hazardous activities that require special attention and quick reactions (driving a car and other vehicles, working with moving machinery, work of dispatcher and operator, etc.).

Administration during pregnancy and breastfeeding

Sufficient data on the use of citicoline in pregnant women are not available. Although no adverse effects were found in animal studies, during pregnancy the drug is prescribed only in cases when the expected benefits to the mother outweigh the potential risk to the fetus.

When prescribing the drug during lactation women should stop breastfeeding, since there is no data on excretion of citicoline with breast milk. The drug may be used in newborns, if it is necessary for medical indications. The drug contains sorbitol therefore it should not be used in patients with fructose intolerance.

Overdose

Taking into account the low toxicity of the drug, overdosing has not been described.

Form of production

Oral solution 100 mg/ml in 30 ml or 50 ml vials, with measuring spoon or cup.

Storage conditions

In a dry, dark place at a temperature not more than 25ºC. Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies.

Released by a doctor’s prescription.

×