COMPOSITION:

Active substance: citicoline sodium;

1 tablet contains citicoline sodium which is equivalent to citicoline 500 mg;

Excipients: lactose monohydrate

microcrystalline cellulose

povidone

croscarmellose sodium

silica colloidal anhydrous

magnesium stearate

Opadry 03F58750 white covering.

INDICATIONS:

⇒ Acute phase of a stroke.

⇒ Treatment of complications and consequences of a stroke.

⇒ Craniocerebral injury and its consequences.

⇒ Cognitive

sensitive

motor and neurological disorders caused by cerebral pathology of degenerative or vascular origin.

DOSAGE:

Recommended dose is 500 tо 2000 mg per day (1 – 4 tablets).

Doses of the preparation and treatment course duration depend on severity of cerebral lesion; they are adjusted by a doctor.

Elderly patients do not need the dose adjustment.

ADVERSE REACTIONS:

Adverse reactions occur very rarely (< 1/10000)

including single cases.

Mentality:

hallucinations

excitement

insomnia.

CNS:

headache

dizziness

tremor.

Cardio-vascular system:

arterial hypertension or hypotension.

Respiratory system:

dyspnea.

Digestive tract:

nausea

vomiting

gastric pain

hypersalivation

insignificant change of hepatic function indexes

diarrhea.

Skin: redness

urticaria

exanthem.

General disorders:

increase of body temperature

fever sensation

trembling

edema.

Drug interactions:

Neurodar® enhances effects of L-dihydroxyphenylalanine and levodopa.

It should not be synchronously used with drugs

which contain meclofenoxate.

Alcohol should not be consumed while the preparation usage.

Pregnancy and lactation:

Preparation administration during pregnancy and lactation period is possible only in case when the expected benefit for a mother overweights a potential risk for a fetus or baby.

Children:

There is no sufficient data concerning citicoline administration to children

therefore Neurodar® should not be administered to this age group of patients.

PRECAUTIONS:

Neurodar® preparation should be administered with caution to patients who suffer from trimethylaminuria

Parkinson’s disease and patients with depression in anamnesis.

Overdose:

Intoxication appearance is unlikely due to low toxicity

even in cases when the therapeutic doses are accidentally exceeded.

In case of accidental overdose a symptomatic therapy is carried out.

Ability to influence reaction velocity while driving or operating any other mechanisms.

In individual cases

some central nervous system adverse reactions may affect the ability to drive a motor transport or operate complicated mechanisms.

Therefore

it is necessary to be caution while driving motor transport or operating other machines during the treatment.

CONTRAINDICATIONS:

⇒ Hypersensitivity to components of the preparation.

⇒Supertension of parasympathetic nervous system.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:

Neurodar® is a nootropic preparation. Citicoline as a predecessor of key ultrastructural component of cell membrane (mainly phospholipids) has a wide spectrum of action:

it promotes a restoration of damaged cell membranes

inhibits an action of phospholipase

preventing a formation of free radicals and prevents cell death by acting on mechanisms of apoptosis.

Neurodar® is a source of choline

it increases a synthesis of acetylcholine and stimulates biosynthesis of structural (foot) phospholipids in neuron membrane.

It improves the transmission of nerve impulses in cholinergic neurons; it has a positive effect on plasticity of neuronal membranes and receptor function. It improves cerebral blood flow

enhances cerebral metabolic processes and activates the structure of cerebral reticular formation.

In acute phase of a stroke it reduces the volume of damaged tissue and improves cholinergic transmission.

Neurodar® alleviates symptoms

which occur during hypoxia and cerebral ischemia

including memory impairment

emotional lability

lack of initiative

difficulty during daily activities and self-service.

In craniocerebral injury it reduces the duration of post-traumatic coma and the severity of neurological symptoms.

Neurodar® has anti-edema properties and reduces cerebral edema due to its stabilizing effect on neuronal membrane.

It accelerates the recovery and reduces the duration and intensity of post-traumatic syndrome.

Neurodar® is effective in the treatment of cognitive

sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics:

Citicoline is well absorbed in oral

intramuscular and intravenous introduction. After the preparation introduction it is observed a significant increase of choline in plasma. The preparation is almost completely absorbed in oral administration. Studies have shown that the bioavailability in per oral and parenteral routes of introduction was similar.

The preparation is metabolized in intestine and liver with the formation of choline and cytidine. After citicoline introduction it is assimilated by cerebral tissues

while cholines act on phospholipids

cytidine – on cytidine nucleoids and nucleic acids. Citicoline quickly reaches cerebral tissues and actively integrates into cell membrane

cytoplasm and mitochondria

activating an activity of phospholipids.

Only a minor part of introduced dose is excreted with urine and feces (less than 3%). Approximately 12% of introduced dose are excreted via respiratory tract.

The preparation excretion via urine and respiratory tract has two phases:

First phase – rapid excretion (with urine – within the first 36 hours

via airways – within the first 15 hours)

the second phase – slow excretion. Major part of the dose is included into the process of metabolism.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties: white

capsule shaped

plain

coated tablets.

Shelf-life:

2 years

Storage:

Store in a dry

protected from light place at the temperature not more than 25° C.

Keep it out of reach of children.

Package:

10 tablets are in a blister

1 blister is in a carton box.

3 or 10 blisters are in a carton box no.30 (10×3) or no.100 (10×10).

Conditions of supply:

By prescription.