Omarone, pills, 30pcs

Composition

Active ingredients: Piracetam 400 mg; Cinnarizine 25 mg; Excipients: Lactose monohydrate 23.5 mg; Magnesium hydroxycarbonate pentahydrate 46.8 mg; Povidone (collidone 30) 3.9 mg; Silicon dioxide colloidal (aerosil A-380) 5.2 mg, Calcium stearate monohydrate 5.2 mg;Crospovidone (collidone CL-M) 10.4 mg

Pharmacological action

A combined drug with a pronounced antihypoxic, nootropic and vasodilating effect. Piracetam activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating glucose utilization by cells and increasing their resistance to hypoxia;improves interneuronal transmission in the central nervous system, improves regional blood flow in the ischemic zone. Cinnarizine is a selective blocker of “slow” calcium channels, reduces the intake of calcium ions into cells and reduces its content in the plasmolemma depot, reduces the smooth muscle tone of arterioles, reduces their response to biogenic vasoconstrictors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin, serotonin). It has a vasodilating effect (especially in relation to the cerebral vessels, increasing the antihypoxic effect of piracetam), without significantly affecting blood pressure. It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system. Increases the elasticity of red blood cell membranes, their ability to deform, and reduces blood viscosity. Suction. After oral use, piracetam and cinnarizine are rapidly and almost completely absorbed in the gastrointestinal tract. The bioavailability of piracetam is about 100%. The maximum concentration (Cmax) of piracetam is reached in 0.5-1 hour after use. The maximum concentration of cinnarizine in plasma is reached after 1-3 hours. The bioavailability of cinnarizine increases in an acidic environment. Distribution. Piracetam does not bind to plasma proteins. The volume of distribution is about 0.6 l / kg. Penetrates through the blood-brain and placental barriers, into all organs and tissues, as well as through the filter membranes used in hemodialysis. Animal studies have shown that piracetam selectively accumulates in the cerebral cortex, mainly in the frontal, parietal and occipital lobes, cerebellum and basal ganglia. Cinnarizine. The binding to plasma proteins is 91%.1-4 hours after ingestion, it is found in the liver, kidneys, heart, lungs, spleen and brain. Metabolism. Piracetam is practically not metabolized in the body. Cinnarizine is actively and completely metabolized by dealkylation; the process of metabolism begins 30 minutes after ingestion. Output. Piracetam. More than 95% of the oral dose is excreted unchanged by the kidneys by renal filtration within 30 hours. The renal clearance of piracetam in healthy volunteers is 86 ml/min. The elimination half-life (T 1/2) is 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid. In patients with renal insufficiency, the T 1/2 lengthens. In patients with hepatic insufficiency, the pharmacokinetics of piracetam do not change. Cinnarizine is excreted from the body in the form of metabolites (1/3-by the kidneys,2/3 – through the intestines), T 1/2 – about 4 hours.

Indications

• indications for primeneniya Omaron: cerebrovascular insufficiency (atherosclerosis of brain vessels, the recovery period of ischemic and hemorrhagic stroke, traumatic brain injury, encephalopathy of different Genesis), intoxication
• and other diseases of the Central nervous system, accompanied by a decrease in intellectual-mental functions (memory impairment, attention, mood), psycho-organic syndrome with prevalence of signs of fatigue and weakness, asthenia
• of labyrinthodontia, Meniere’s syndrome
• , the backlog of intellectual development in children, prevention of migraine and kinetoses. with

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

Contraindications

Hypersensitivity to the main and/or auxiliary components of the drug; severe hepatic insufficiency; severe renal insufficiency (creatinine clearance less than 20 ml/min); hemorrhagic stroke; Parkinsonism (including Parkinson’s disease); psychomotor agitation; Huntington’s disease; pregnancy;lactation; children under 5 years of age; lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose). With caution, liver and/or kidney diseases, chronic renal failure (creatinine clearance 20-80 ml / min); increased intraocular pressure; porphyria; impaired hemostasis; extensive surgical interventions;severe bleeding; hyperthyroidism; epilepsy; severe cerebral vascular atherosclerosis; a tendency to neurotic reactions.

Side effects

Central and peripheral nervous system disorders:  motor disinhibition, irritability, drowsiness, depression, asthenia, headache.

In isolated cases, dizziness, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, unbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality are noted.

From the cardiovascular system:  decrease or increase in blood pressure.

From the digestive system:  dyspeptic symptoms, dry mouth; in isolated cases-nausea, vomiting, diarrhea, abdominal pain, cholestatic jaundice.

From the side of the skin:  in isolated cases, dermatitis, pruritus, skin rash.

From the side of metabolism:  weight gain.

Allergic reactions:  angioedema.

Other services:  increased sweating; in isolated cases – lupus-like syndrome, lichen planus.

Interaction

With simultaneous use, it is possible to increase the sedative effect of drugs that inhibit the activity of the central nervous system, as well as ethanol, nootropic and antihypertensive drugs.

Vasodilating agents enhance the effect of the drug.

Improves the tolerability of antipsychotic medications and tricyclic antidepressants.

When used concomitantly, piracetam enhances the central effects of thyroid hormones (tremor, anxiety, irritability, sleep disorders are possible); it can enhance the effect of oral anticoagulants.

How to take, course of use and dosage

Inside, during or after a meal. Adults: 1-2 tablets 3 times a day for 1-3 months, depending on the severity of the disease. It is possible to conduct repeated courses of treatment — 2-3 times a year. Children over 5 years of age: 1-2 tablets 1-2 times a day. Do not use for more than 3 months. For prevention of kinetosis: in adults-1 tablet, in children over 5 years-1/2 tablet 30 minutes before the start of the trip, with repeated intake (if necessary) every 6-8 hours. Patients with impaired renal function: with chronic renal failure (creatinine clearance 20-80 ml / min) – 1 tablet 2 times a day.

Overdose

Symptoms of overdose caused mainly by the m-holinoblocking activity of cinnarizine include: impaired consciousness, vomiting, extrapyramidal symptoms, and decreased blood pressure. After oral use of piracetam at a dose of 75 g, diarrhea with blood and abdominal pain were observed.

Treatment:  there is no specific antidote. In case of overdose, gastric lavage and use of activated charcoal, symptomatic and maintenance therapy are necessary. The effectiveness of hemodialysis for piracetam is 50-60%.

Special instructions

With prolonged use, monitoring of liver and kidney function is recommended (especially in patients with chronic renal failure).

During treatment, patients with arterial hypotension may have a more significant decrease in blood pressure.

Alcohol consumption during treatment is not recommended.

The results of doping tests and allergic skin tests may be distorted; the drug should be discontinued 4 days before the study.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets 400 mg+25 mg. 10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. 3,6 or 9 contour cell packages together with instructions for medical use of the drug are placed in a pack of cardboard.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Piracetam, Cinnarizine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 5 years of age

Indications

Concussion and other traumatic brain injuries, Prevention of heart attacks and strokes, Atherosclerosis, Asthenia, Consequences of stroke, Cerebral circulation disorders, Meniere ‘s disease