Mebix^® (Tablets) Instructions for Use

Marketing Authorization Holder

Mebix, LLC (Russia)

Manufactured By

Korporatsiya OLIFEN, CJSC (Russia)

ATC Code

N06BX21 (Temgicoluril)

Active Substance

Temgicoluril (Rec.INN registered by WHO)

Dosage Form

Mebix®

Tablets 500 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, with a score and a bevel.

Excipients: potato starch, calcium stearate.

10 pcs. – blister packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Anxiolytic (tranquilizer)

Pharmacotherapeutic Group

Psychoanaleptics, other psychostimulants and nootropic drugs

Pharmacological Action

Anxiolytic agent, tetramethyltetraazabicyclooctanedione. It also has an anticonvulsant effect.

Without having a direct hypnotic effect, it regulates disturbed night sleep.

It does not exhibit central or peripheral anticholinergic properties.

The anxiolytic effect is not accompanied by muscle relaxation and impaired coordination of movements.

Pharmacokinetics

Excreted by the kidneys within 24 hours after administration.

Indications

Neuroses and neurosis-like states (irritability, emotional lability, anxiety, fear).

Anxiety-paranoid syndrome in schizophrenia, involutional and vascular psychoses.

Chronic verbal hallucinosis of organic genesis.

Complex therapy for the treatment of patients with cardialgia, coronary artery disease and rehabilitation after myocardial infarction.

Reduction of craving for tobacco smoking, ethanol, psychoactive substances; improvement of tolerance to neuroleptics and tranquilizers.

ICD codes

Dosage Regimen

Administer orally, regardless of meals.

For adults, the typical dosage is 500 mg to 1000 mg (1-2 tablets) taken two to three times daily.

Do not exceed a single dose of 3000 mg (6 tablets).

The maximum daily dose is 10,000 mg (20 tablets).

For neurotic and neurosis-like states, the treatment course typically lasts up to 2-3 months.

For chronic mental illnesses, including schizophrenia and organic psychoses, treatment may extend up to 6 months.

In complex therapy for coronary artery disease and post-myocardial infarction rehabilitation, adhere to the standard dosing schedule.

For reducing cravings for tobacco, ethanol, or psychoactive substances, use the standard anxiolytic dosage.

To improve tolerance to neuroleptics and tranquilizers, administer concurrently at the standard dosage.

Adverse Reactions

Possible allergic reactions (skin itching), decreased blood pressure, hypothermia (by 1-1.5°C (29.3°F)), dyspepsia.

Contraindications

Hypersensitivity to temgicoluril.

Special Precautions

Decreased blood pressure and body temperature are not a reason to discontinue therapy and normalize on their own.

Effect on the ability to drive vehicles and machinery

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

Drug Interactions

Enhances the effect of hypnotics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.