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Dosage form: & nbsppills
Composition:

One tablet contains:

Active substance: vinpocetine - 5 mg.

Excipients: lactose monohydrate - 66.55 mg, low-substituted giprolose-16.00 mg, magnesium stearate - 0.75 mg, talc - 1.70 mg.

Description:

Round tablets, flat-cylindrical shape, white. On one side is an imprint of the Covex Company logo, SA, on the other - a risk.

Pharmacotherapeutic group:Cerebral blood flow improver
Pharmacodynamics:

Vinpocetine selectively inhibits the potential-dependent sodium channels, causing a dose-dependent decrease in calcium concentration in the endings of neurons of the striatum. It is believed that a decrease in the sodium current has a neuroprotective effect due to a decrease in excitotoxicity and a weakening of neuronal damage caused by cerebral ischemia or reperfusion.

Vinpocetine increases the concentration of 3,4-dihydroxyphenylacetic acid (dopamine metabolite) in the nerve endings of the striatum. This action is similar to the pharmacological action of reserpine (reminiscent of the chemical structure vinpocetine), which depletes the supplies of catecholamines in the nerve endings of the brain, which causes side effects from the cardiovascular system and the antipsychotic effect.

It also inhibits phosphodiesterase 1, which leads to an increase in the concentration of intracellular cyclic guanosine monophosphate. This leads to relaxation of smooth muscle vessels of the brain.

Pharmacokinetics:Bioavailability of vinpocetine after taking an empty stomach is about 7 %. TSmah in blood plasma - 1 hour, in tissues - 2-4 hours. When passing through the wall of the intestine is not exposed to metabolism. When introducing repeated doses, the kinetics is linear. The connection with plasma proteins is 66%, the clearance is 66.7 l / h, exceeds the hepatic clearance (50 l / h). That indicates extrahepatic metabolism. Penetrates into breast milk (0.25 during the 1st hour), through the placental barrier. Т1 / 2 - 3,54-6,12 ч. It is deduced by kidneys and an intestine in the ratio 3: 2.
Indications:

Neurology (as part of complex therapy): as a symptomatic agent for various forms of cerebral circulatory insufficiency (ischemic stroke, restorative stage of hemorrhagic stroke, consequences of a stroke, transient ischemic attack, vascular dementia, circulatory failure in the vertebrobasilar basin, atherosclerosis of cerebral vessels, posttraumatic and hypertensive encephalopathy).

Ophthalmology: chronic vascular diseases of the choroid and retina (including occlusion of the central artery or retinal vein).

Perceptive hearing loss, Meniere's disease, idiopathic tinnitus.

Contraindications:

Hypersensitivity to the components of the drug, severe heart rhythm disturbances, coronary heart disease (severe course), acute stage of hemorrhagic stroke, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, pregnancy, lactation.

Vinpocetine is not recommended for use in children and adolescents under 18 years (due to insufficient data).

Pregnancy and lactation:The use of the drug during pregnancy, during lactation and children under 18 is contraindicated.
Dosing and Administration:

Inside after eating 5-10 mg (1-2 tablets) 3 times a day for 2 months. Before cancellation of the drug should gradually reduce dosage. Possible repeated courses 2-3 times a year.

In case of skipping the drug, with the next admission, the dose should not be increased.

Do not exceed the recommended dose of the drug.

Side effects:

The incidence of adverse reactions listed below was determined as follows:

- Often1/10;

- often ≥ 1/100, < 1/10;

- infrequently ≥ 1/1000, <1/100;

- rarely ≥ 1/10000, < 1/1000

- very rarely <1/10000, including individual messages.

From the cardiovascular system: rarely - segment depression ST and elongation QT interval, tachycardia, extrasystole, but the presence of a causal relationship between adverse reactions and treatment Vinpocetine not proven in a natural population, these symptoms are observed with the same frequency; infrequently - a change in blood pressure (often a decrease), redness of the skin.

From the central nervous system: infrequently - sleep disturbances (insomnia, increased drowsiness), dizziness, headache, general weakness (may be manifestations of the underlying disease).

From the digestive system: infrequently - nausea, heartburn, dry mouth.

From the side of the skin: infrequently increased sweating, skin hyperemia.

Allergic reactions: infrequently - a skin rash.

If any of the side effects listed in the manual are aggravated, or you notice any other side effects not specified in the instructions, inform the doctor about it.

Overdose:

Symptoms of overdose are unknown.According to the literature, a dose of 60 mg / day is safe. A one-time receipt of 360 mg of vinpocetine is not accompanied by the development of any cardiovascular or other side effects.

Treatment: gastric lavage, reception of activated charcoal and symptomatic treatment.
Interaction:

The simultaneous use of vinpocetine with beta-blockers (hloranololom, pindolol), clopamide, glibenclamide, digoxin, acenocoumarol or hydrochlorothiazide in clinical trials was not accompanied by manifestations of any interaction.

With simultaneous use of vinpocetine and methyldopa may be some increased hypotensive effect, so when using this combination requires regular monitoring of blood pressure.

Despite the lack of data from clinical trials confirming the possibility of drug interaction, it is recommended that caution should be used vinpocetine simultaneously with preparations of the central action, antiarrhythmic and anticoagulant agents.

If you take other drugs, before taking vinpocetine necessarily consult your doctor.

Special instructions:

If there is a symptom of an elongated interval QT or with the simultaneous use of drugs that cause the lengthening of the interval QT, it is recommended to monitor the ECG.

In case of lactose intolerance, it should be taken into account that one tablet of the preparation contains 66.55 mg of lactose monohydrate.

Patients with diseases of the liver and / or kidney correction of the dosing regimen when taken orally is not required.

Effect on the ability to drive transp. cf. and fur:

Care should be taken when taking the medication when driving a car and when working with moving machinery.

Form release / dosage:Tablets of 5 mg.
Packaging:

For 25 tablets in PVC / AL contour cell packaging. For 1, 2 or 3 contour squares in a cardboard pack together with instructions for medical use.

Storage conditions:

Store in a dark place at a temperature of 15-35 ° C.

Keep away from children.

Shelf life:

5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:П N015345 / 01
Date of registration:22.10.2008
Expiration Date:Unlimited
The owner of the registration certificate:Koveks S.A.Koveks S.A. Spain
Manufacturer: & nbsp
Representation: & nbspKOVEX A.O. KOVEX A.O. Spain
Information update date: & nbsp19.02.2017
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