Omaron^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substances

Piracetam (Rec.INN registered by WHO)

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Omaron®

Tablets 400 mg+25 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets white in color, round, flat-cylindrical, with a score on one side and a bevel on two sides; marbling of the surface is allowed.

Excipients : lactose monohydrate, heavy magnesium carbonate, povidone K30, colloidal silicon dioxide (aerosil A-380), calcium stearate, crospovidone (kollidon CL-M).

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A combined drug with antihypoxic, nootropic, and vasodilating effects.

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 CNS, and improves regional blood flow in the ischemic zone.

Cinnarizine is a selective blocker of slow calcium channels, inhibits the entry of calcium ions into cells and reduces their content in the plasmalemma depot, reduces the tone of arteriole smooth muscle, and reduces their response to biogenic vasoconstrictor substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin). It has a vasodilating effect (especially concerning the vessels of the brain, enhancing the antihypoxic effect of piracetam), without significantly affecting blood pressure. It exhibits moderate antihistamine activity, reduces the excitability of the vestibular apparatus, and lowers the tone of the sympathetic nervous system. It increases the elasticity of erythrocyte membranes, their ability to deform, and reduces blood viscosity.

Pharmacokinetics

Absorption

After oral administration, Piracetam and Cinnarizine are rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of piracetam is about 100%. C_max of piracetam is reached 0.5-1 hour after administration. C_max of cinnarizine in plasma is reached 1-3 hours after administration. The bioavailability of cinnarizine increases in an acidic environment.

Distribution

Piracetam does not bind to plasma proteins. V_d is about 0.6 l/kg. It penetrates the blood-brain barrier and placental barrier, into all organs and tissues, as well as through filter membranes used in hemodialysis. Animal studies have found that Piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal, and occipital lobes, cerebellum, and basal ganglia.

The plasma protein binding of cinnarizine is 91%. 1-4 hours after oral administration, it is detected 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 metabolism process begins 30 minutes after oral administration.

Excretion

More than 95% of the orally administered dose of piracetam is excreted by the kidneys unchanged by renal filtration within 30 hours. The renal clearance of piracetam in healthy volunteers is 86 ml/min. T_1/2 is 4-5 hours from plasma and 8.5 hours from cerebrospinal fluid. In patients with renal failure, T_1/2 is prolonged. In patients with hepatic impairment, the pharmacokinetics of piracetam do not change.

Cinnarizine is excreted from the body as metabolites (1/3 by the kidneys, 2/3 through the intestines), T_1/2 is about 4 hours.

Indications

CNS diseases accompanied by a decrease in intellectual and mnestic functions.

As part of complex therapy:

• Cerebrovascular insufficiency (cerebral atherosclerosis, recovery period after ischemic and hemorrhagic stroke);
• Post-intoxication or post-traumatic encephalopathy;
• Depression;
• Psycho-organic syndrome with a predominance of signs of asthenia and adynamia;
• Vestibular disorders;
• Ménière’s syndrome;
• Intellectual developmental delay in children;
• Migraine prevention;
• Prevention of motion sickness in adults and children.

ICD codes

Dosage Regimen

Orally, during or after meals.

Adults – 1-2 tablets 3 times/day for 1-3 months, depending on the severity of the disease. Repeated courses of treatment are possible – 2-3 times a year.

Children over 5 years old – 1-2 tablets 1-2 times/day. Do not use for more than 3 months.

For prevention of motion sickness : adults – 1 tablet, children over 5 years old – 1/2 tablet 30 minutes before the start of the journey, with repeated administration (if necessary) every 6-8 hours.

For chronic renal failure (creatinine clearance 20-80 ml/min) – 1 tablet 2 times/day.

Adverse Reactions

From the central and peripheral nervous system motor disinhibition, irritability, drowsiness, depression, asthenia, headache. In isolated cases, dizziness, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality were noted.

From the cardiovascular system decrease or increase in blood pressure.

From the digestive system dyspeptic phenomena, dry mouth sensation; in isolated cases – nausea, vomiting, diarrhea, abdominal pain, cholestatic jaundice.

From the skin in isolated cases dermatitis, itching, skin rash.

From metabolism weight gain.

Allergic reactions angioedema.

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

Contraindications

• Severe hepatic insufficiency;
• Severe renal failure (creatinine clearance less than 20 ml/min);
• Hemorrhagic stroke; parkinsonism (including Parkinson’s disease);
• Psychomotor agitation;
• Huntington’s disease;
• Pregnancy;
• Lactation period;
• Children under 5 years of age;
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose);
• Hypersensitivity to the main and/or auxiliary components of the drug.

With caution: liver and/or kidney diseases, chronic renal failure (creatinine clearance 20-80 ml/min); increased intraocular pressure; porphyria; hemostasis disorders; extensive surgical interventions; severe bleeding; hyperthyroidism; epilepsy; severe cerebral atherosclerosis; tendency to neurotic reactions.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal failure (creatinine clearance less than 20 ml/min).

In chronic renal failure (creatinine clearance 20-80 ml/min) – 1 tablet 2 times/day.

Pediatric Use

Children over 5 years old – 1-2 tablets 1-2 times/day. Do not use for more than 3 months.

For prevention of motion sickness : children over 5 years old – 1/2 tablet 30 minutes before the start of the journey, with repeated administration (if necessary) every 6-8 hours.

Contraindicated in children under 5 years of age.

Special Precautions

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

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

Alcohol consumption is not recommended during treatment.

Distortion of the results of doping tests and allergic skin tests is possible; the drug should be discontinued 4 days before the study.

Effect on the ability to drive vehicles and machinery

During treatment, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

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

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

Drug Interactions

With simultaneous use, the sedative effect of drugs that depress the activity of the central nervous system, as well as ethanol, nootropic and antihypertensive agents, may be enhanced.

Vasodilating agents enhance the effect of the drug.

Improves the tolerability of antipsychotic drugs and tricyclic antidepressants.

With simultaneous use, Piracetam enhances the central effects of thyroid hormones (tremor, anxiety, irritability, sleep disturbances are possible).

May enhance the effect of oral anticoagulants.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.