The instruction for medical use of VINPOCETINE medicine the Trade name the Vinpocetine the International unlicensed name Vinpocetine Dosage Form of the Tablet of 5 mg Structure One tablet contains active agent – a Vinpocetine of 5 mg, excipients: talc, starch corn, lactoses monohydrate, magnesium stearate. Description of the Tablet of color, white or white with slightly grayish shade, Pharmacotherapeutic group Nervous system. Psychoanaleptics. The psychostimulants primenyamy at deficit of attention and hyperactivity (ADHD – Attention deficit hyperactivity disorder) and nootropic means. Other psychostimulants and nootropic means. Vinpocetine. The ATX N06BX18 code the Pharmacological Pharmacokinetics At properties intake the Vinpocetine is well soaked up in digestive tract. The maximum concentration in blood is reached in 2-4 hours after intake. Concentration in tissues of a brain does not exceed concentration in blood. The bioavailability is 7%. Distribution volume – 3-8 l. Contacts proteins of blood plasma for 66%. Easily gets through gistogematichesky barriers, including through a blood-brain barrier and also through a placenta and it is allocated in breast milk. It is metabolized in a liver with formation of several metabolites. The main metabolite of a Vinpocetine, apovinkaminovy acid (AVK), is formed in a human body in number of 25-30% in the course of metabolism of primary passing of a Vinpocetine through a liver. In comparison with intravenous administration after administration of drug inside the size AUC ABK is twice more. Other metabolites of a Vinpocetine: hydroxyvinpocetine, hydroksi-AVK, glitsinat dihydroxy-apo-vinkaminovoy of acid and their sulphatic and glyukuronidny conjugates. Important and significant property of a Vinpocetine is the lack of need of special selection of a dose of drug at patients with diseases of a liver or kidneys in view of metabolism of drug and lack of cumulation (accumulation). Diseases of a liver and kidneys do not influence metabolism of a Vinpocetine. It is excreted with urine and bile, generally in the form of the metabolites conjugated with glucuronic acid. Elimination half-life makes 4.8 hours. Thanks to absence the Vinpocetine gepato- and nephrotoxic action, has no need to adjust a dose at patients with diseases of a liver and kidneys. Advanced age: elderly and young patients have no essential differences in drug kinetics, drug does not kumulirutsya. The patient with chronic diseases of a liver and kidneys drug is appointed in a usual dose, the lack of cumulation allows to conduct long courses of treatment. A pharmacodynamics the Vinpocetine – tserebroprotektorny means. Improves cerebral circulation, rheological properties of blood and brain metabolism, increases resistance of tissues of brain to the damaging action of ischemia. The effect is implemented at the expense of the complex mechanism of action. Selectively strengthens a brain blood stream and cerebral fraction of minute volume of blood, reduces brain vascular resistance, without influencing system blood circulation (arterial blood pressure, minute volume of blood, pulse rate, the general peripheric resistance of vessels). Strengthens, first of all, blood supply of the struck, ischemic zone of a brain, without causing a phenomenon of burglarizing, at the same time blood supply of healthy area does not change. Improves microcirculation in a brain, slows down aggregation of thrombocytes, reduces the increased viscosity of blood, increases elasticity of erythrocytes and blocks absorption of adenosine by them. In a hypoxia reduces in brain tissues expressiveness damaged by the stimulating amino acids of cytologic reactions, inhibits functional activity of cellular transmembrane sodium and calcic tubules, exponentiates neurotyre-tread effect of adenosine. Promotes oxygen transport to fabrics owing to decrease in affinity of erythrocytes to it. Stimulates glucose transport through a blood-brain barrier and strengthens her metabolism, transferring it to energetically more favorable aerobic way. Selectively inhibits Sa2+-kalmodulin-zavisimuyu tsGMF-phosphodiesterase, increases concentration of tsAMF and tsGMF, content of ATP and a ratio of ATF/AMF in brain tissues. Stimulates cerebral metabolism of noradrenaline and serotonin and also the ascending noradrenergichesky system, has anti-oxidizing effect. Indications – the different forms of disturbance of cerebral circulation which are followed by neurologic or mental disorders (states after a stroke, vascular dementia, vertebro-basilar insufficiency, atherosclerosis of vessels of a brain, posttraumatic and hypertensive encephalopathy) – chronic vascular diseases of a choroid and a retina of an eye – decrease in hearing of perceptual character, Menyer’s disease, a ring in ears the Route of administration and doses accept the Vinpocetine inside the adult on 5 – 10 mg (1-2 tablets) 3 times a day. Improvement occurs usually in 1-2 weeks. Duration of a course of treatment is defined by the doctor. Side effects Infrequently (& gt, 1/1000 to & lt, 1/100): – a headache, dizziness – a lowering of arterial pressure – nausea, dryness in a mouth, discomfort in a stomach – a hypercholesterolemia. Seldom (& gt, 1/10000 to & lt, 1/1000): – sleep disorders (insomnia, the increased drowsiness), concern, a stupor, a hemiparesis, amnesia – vomiting, dyspepsia, a loss of appetite, anorexia, a dysgeusia, diarrhea, a constipation, an abdominal pain – hypostasis of an optic nerve – a hyperacusia, a gipoakuziya, sonitus – increase in arterial blood pressure, tachycardia, bradycardia, premature ventricular contraction, an angina of exertion, an ischemia/myocardial infarction, ST segment depression, lengthening of QT – inflows, the general weakness, an asthenia – thrombophlebitis – diabetes – an erythema, a hyperhidrosis, an itching, skin rash, a small tortoiseshell – a leukopenia, thrombocytopenia, decrease/increase in number of eosinophils – increase in level of triglycerides in blood, change of activity of hepatic enzymes. Very seldom (& lt, 1/10000): – a tremor, spasms, a depression, euphoria – conjunctiva hyperaemia – arrhythmia, fibrillation of auricles – a dysphagy, stomatitis – discomfort in a thorax, a hypothermia – dermatitis – anemia, agglutination of erythrocytes, increase/decrease in number of leukocytes, decrease in number of erythrocytes, shortening of a prothrombin time – increase in body weight. Contraindications – hypersensitivity to drug components – coronary heart disease – disturbances of a heart rhythm – pregnancy and the period of a lactation – children’s age up to 18 years (lack of clinical data) – to persons with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption Medicinal interactions Simultaneous use of a Vinpocetine with b-blockers (chloranololy, Pindololum), Clopamidum, glibenclamide, digoxin, atsenokumaroly or a hydrochlorothiazide in clinical trials was not followed by any interaction between them. Simultaneous use of a Vinpocetine and a-Methyldopums sometimes served as the reason of some strengthening of hypotensive effect therefore at such treatment the regular control of pressure of blood is required. Despite of lack of these clinical trials confirming a possibility of interaction it is recommended to show care at co-administration of a Vinpocetine with drugs which affect the central nervous system, antiarrhythmic and anticoagulating means. The special instructions Existence of a Syndrome of the Prolonged Interval of QT and Administration of Drugs, QT causing lengthening of an interval, demand carrying out periodic control of the electrocardiogram (ECG). Drug contains lactose therefore patients should not appoint it with with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, malabsorption of glucose galactose of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: strengthening of side effects. Treatment: symptomatic therapy. The dose of 60 mg/day is safe. One-time reception of 360 mg of a Vinpocetine was not followed by development of either cardiovascular, nor other side effects. When developing intoxication the gastric lavage is recommended. Intake of activated carbon, symptomatic treatment. A form of release and packing On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil with a unilateral covering thermovarnish and the press from other party or printing aluminum foil varnished or the bezosnovny aluminum foil. On the 3rd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in original packing at a temperature not above 25 °C. To store out of children’s reach! 4 years not to apply a period of storage after an expiration date. Prescription status According to the prescription LLC Pharmaceutical Company Zdorovye Producer. Ukraine, 61013, Kharkiv, Shevchenko St., 22. Packer of LLC Pharmaceutical Company Zdorovye. Ukraine, 61013, Kharkiv, Shevchenko St., 22. Owner of the registration certificate of LLC GNCLS Experimental Plant. Ukraine, 61057, Kharkiv, Vorobyov St., 8. The name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers, responsible for post-registration observation of safety of medicine: Alexander Evgenyevich Guskov Republic of Kazakhstan, 050039, Almaty, Mailing St., 72, apartment 34 Ph.: +7 (727) 271-10-17 Fax: +7 (727) 271-84-97 E-mail:
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