Piracezine^® (Capsules) Instructions for Use

Marketing Authorization Holder

Minskintercaps Up (Republic Of Belarus)

Contact Information

MINSKINTERCAPS (Republic of Belarus)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substances

Piracetam (Rec.INN registered by WHO)

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Piracezine®

Capsules 400 mg/25 mg: 10 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, white in color, cylindrical in shape with hemispherical ends; the contents of the capsules are a white or almost white powder.

Excipients: calcium stearate, basic light magnesium carbonate.

Capsule shell composition gelatin – 80.784 mg, purified water – 13.92 mg, titanium dioxide (E171) – 1.1808 mg, sodium lauryl sulfate – 0.1152 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Other psychostimulants and nootropic drugs

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. It improves interneuronal transmission in the central nervous system and regional blood flow in the ischemic zone.

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

Pharmacokinetics

Pharmacokinetic data for the drug Piracezine^® have not been provided.

Indications

• Cerebrovascular accidents (ischemic stroke, recovery period after hemorrhagic stroke);
• Encephalopathies of various origins;
• Intoxications;
• Brain injuries;
• Diseases of the central nervous system accompanied by a decrease in intellectual and mnestic functions;
• Psycho-organic syndrome with a predominance of asthenia and adynamia symptoms;
• Asthenic syndrome;
• Labyrinthopathies;
• Ménière’s syndrome;
• Prevention of motion sickness;
• Intellectual developmental delay in children;
• Migraine prevention.

ICD codes

Dosage Regimen

Administer the capsules orally, with water, during or after a meal.

For adults, prescribe 1-2 capsules three times daily. The standard treatment duration is 1 to 3 months, depending on the severity of the disease state and individual patient response.

For long-term management, repeat the treatment course 2-3 times per year as medically indicated.

For children over 5 years of age, prescribe 1-2 capsules once or twice daily. Adjust the frequency based on the child’s tolerance and therapeutic needs.

Do not administer to children under 5 years of age due to contraindication.

In patients with hepatic or renal impairment, avoid use entirely as the drug is contraindicated.

For the prevention of motion sickness, take a single dose of 1-2 capsules 30 minutes before the anticipated motion exposure.

Adhere strictly to the prescribed dosage and duration. Do not exceed the recommended daily intake.

Adverse Reactions

Possible irritability, sleep disorders, nausea, dyspepsia.

Contraindications

• Hepatic insufficiency;
• Renal insufficiency;
• Pregnancy;
• Lactation (breastfeeding);
• Children under 5 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Piracezine^® is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated in hepatic insufficiency.

Use in Renal Impairment

The drug is contraindicated in renal insufficiency.

Pediatric Use

The drug is contraindicated in children under 5 years of age.

Children over 5 years old are prescribed 1-2 capsules 1-2 times/day.

Overdose

To date, no cases of overdose with Piracezine^® have been reported.

Drug Interactions

With simultaneous use with Piracezine^®, it is possible to enhance the effects of nootropic, adaptogenic, hypotensive drugs, as well as agents that depress the activity of the central nervous system (including ethanol).

Piracezine^® improves the tolerability of antipsychotic drugs and tricyclic antidepressants.

When used together, Piracezine^® weakens the effect of hypertensive agents.

Storage Conditions

The drug should be stored in a place protected from light and out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 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.