Vinpolizim (Tablets) Instructions for Use

Marketing Authorization Holder

Veltrade, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

ATC Code

N06BX18 (Vinpocetine)

Active Substance

Vinpocetine (Rec.INN registered by WHO)

Dosage Forms

	Vinpolizim	Tablets 5 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 pcs.
		Tablets 10 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose (type 101), povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), magnesium stearate, sodium carboxymethyl starch (sodium starch glycolate, Promogel).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose (type 101), povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), magnesium stearate, sodium carboxymethyl starch (sodium starch glycolate, Promogel).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

A drug that improves cerebral circulation and cerebral metabolism. It inhibits the activity of phosphodiesterase, which promotes the accumulation of cAMP in tissues.

It has a vasodilating effect primarily on the cerebral vessels, which is due to a direct myotropic antispasmodic action. Systemic blood pressure decreases slightly.

It improves blood supply and microcirculation in brain tissues, reduces platelet aggregation, and helps normalize the rheological properties of blood.

It improves the tolerance of brain cells to hypoxia by promoting oxygen transport to tissues due to a decrease in the affinity of erythrocytes for it, and enhances the uptake and metabolism of glucose. It increases the content of catecholamines in brain tissues.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. C_max in blood plasma is reached approximately after 1 hour.

With parenteral administration, V_d is 5.3 l/kg. T_1/2 is about 5 hours.

Indications

Acute and chronic cerebral circulation insufficiency. Dyscirculatory encephalopathy accompanied by memory impairment, dizziness, headache. Post-traumatic encephalopathy. Vascular diseases of the retina and choroid of the eye.

Hearing impairment of vascular or toxic origin, Meniere’s disease, labyrinthine vertigo. Vegetative-vascular dystonia in menopausal syndrome.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

The standard adult dosage is 5 mg to 10 mg taken three times daily.

For the 5 mg tablet, the regimen is one to two tablets per dose.

For the 10 mg tablet, the regimen is one-half to one tablet per dose.

Break the scored tablet to achieve the prescribed dose.

Initiate treatment at the lower end of the dosage range.

Titrate the dose based on individual patient tolerance and therapeutic response.

The maximum daily dose should generally not exceed 30 mg.

The duration of therapy is determined by the treating physician based on the underlying condition.

For chronic disorders, long-term treatment may be required.

In acute conditions, parenteral therapy may be initiated first.

Transition to oral administration after the acute phase has stabilized.

Discontinue treatment if severe adverse reactions occur.

Do not administer to children or adolescents under 18 years of age.

Adverse Reactions

From the hematopoietic system rarely – leukopenia, thrombocytopenia, decrease/increase in the number of eosinophils; very rarely – anemia, erythrocyte agglutination, erythrocytopenia.

From the immune system very rarely – hypersensitivity reactions.

From metabolism infrequently – hypercholesterolemia; rarely – decreased appetite, anorexia, diabetes mellitus, hypertriglyceridemia; very rarely – increased body weight.

Mental disorders rarely – insomnia, sleep disorder, anxiety; very rarely – euphoria, depression.

From the nervous system infrequently – headache; rarely – dizziness, dysgeusia, stupor, hemiparesis, drowsiness, amnesia; very rarely – tremor, spasms.

From the organ of vision rarely – optic disc edema; very rarely – conjunctival hyperemia.

From the organ of hearing and labyrinthine disorders infrequently – vertigo; rarely – hyperacusis, hypoacusis, tinnitus.

From the cardiovascular system infrequently – decreased BP; rarely – myocardial ischemia/infarction, angina pectoris, bradycardia, tachycardia, extrasystole, palpitation sensation, increased BP, “hot flashes”, thrombophlebitis; rarely – ST segment depression on ECG; very rarely – arrhythmia, atrial fibrillation, BP lability.

From the digestive system infrequently – abdominal discomfort, dry mouth, nausea; rarely – epigastric pain, constipation, diarrhea, dyspepsia, vomiting, increased activity of liver enzymes; very rarely – dysphagia, stomatitis.

From the skin and subcutaneous tissues rarely – erythema, hyperhidrosis, pruritus, urticaria, rash; very rarely – dermatitis.

Other rarely – asthenia, malaise, feeling of heat; very rarely – feeling of discomfort in the chest, hypothermia, decrease in prothrombin time values.

Contraindications

Hypersensitivity to vinpocetine; pregnancy, breastfeeding period; children and adolescents under 18 years of age; for parenteral use – acute phase of hemorrhagic stroke, severe coronary artery disease, severe forms of arrhythmia.

With caution

For parenteral use: increased intracranial pressure, use of antiarrhythmic drugs, long QT syndrome.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use during breastfeeding is contraindicated.

Use in Hepatic Impairment

In liver diseases, use at the usual dose.

Use in Renal Impairment

In kidney diseases, use at the usual dose.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

Used in elderly patients as indicated.

Special Precautions

Use orally with caution in arrhythmia, angina pectoris, with unstable blood pressure and reduced vascular tone. Parenterally, as a rule, used in acute cases until the clinical picture improves, then switch to oral administration. For chronic diseases, Vinpocetine is taken orally. In hemorrhagic cerebral stroke, parenteral administration of vinpocetine is allowed only after the acute phenomena have subsided (usually 5-7 days).

Drug Interactions

When used concomitantly with warfarin, a slight decrease in the anticoagulant effect of warfarin has been reported.

Concomitant use of vinpocetine and alpha-methyldopa sometimes caused some enhancement of the hypotensive effect, so with such treatment, regular blood pressure monitoring is required.

Despite the lack of data confirming the possibility of interaction, caution is recommended when co-administering with drugs acting on the central nervous system and with drugs of antiarrhythmic and anticoagulant action.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.