Dapten-LF (Tablets) Instructions for Use

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

ATC Code

N06BX21 (Temgicoluril)

Active Substance

Temgicoluril (Rec.INN registered by WHO)

Dosage Forms

	Dapten-LF	Tablets 300 mg: 20 pcs.
		Tablets 500 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, flat-cylindrical in shape, with a bevel and a score line.

Excipients: calcium stearate – 0.62 mg, povidone (K-90) – to make a tablet with a mass of 309 mg.

10 pcs. – blister packs (2) – cardboard packs.

Tablets white or almost white, flat-cylindrical in shape, with a bevel and a score line.

Excipients: calcium stearate – 1.03 mg, povidone (K-90) – to make a tablet with a mass of 515 mg.

10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Anxiolytic (tranquilizer)

Pharmacotherapeutic Group

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 or impaired coordination of movements.

Pharmacokinetics

It is 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 origin.

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 antipsychotics and tranquilizers.

ICD codes

Dosage Regimen

Take tablets orally, regardless of food intake.

For adults, use a dose of 0.3-1 g taken two to three times daily.

Do not exceed a maximum single dose of 3 g.

Do not exceed a maximum daily dose of 10 g.

For neurotic and neurosis-like states, continue treatment for up to 2-3 months.

For chronic mental illnesses, such as schizophrenia, continue treatment for up to 6 months.

For complex therapy of cardialgia or coronary artery disease, follow the dosage prescribed by a physician.

To reduce craving for tobacco or ethanol, adhere to the established dosing schedule.

To improve tolerance to antipsychotics, administer concurrently as directed.

Swallow the tablet whole with water; the scored tablet allows for dose splitting if required.

Adjust the dose based on therapeutic response and tolerability.

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

A decrease in blood pressure and body temperature is not a reason to discontinue therapy and normalizes on its own.

Effect on the ability to drive vehicles and mechanisms

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

It 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.