Fabosed^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

N05BX04 (Fabomotizole)

Active Substance

Fabomotizole (Rec.INN registered by WHO)

Dosage Form

Fabosed®

Tablets 10 mg: 60, 90, or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets white, white with a yellowish or white with a brownish tint, round, flat-cylindrical, with a bevel.

Excipients: potato starch, microcrystalline cellulose 101, lactose monohydrate, povidone K25 (polyvinylpyrrolidone medium molecular K-25), magnesium stearate.

30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Anxiolytic (tranquilizer)

Pharmacotherapeutic Group

Psycholeptics; anxiolytics; other anxiolytics

Pharmacological Action

Selective non-benzodiazepine anxiolytic. By acting on σ₁-receptors in the nerve cells of the brain, Fabomotizole stabilizes GABA/benzodiazepine receptors and restores their sensitivity to endogenous inhibitory mediators. It also increases the bioenergetic potential of neurons and has a neuroprotective effect: it restores and protects nerve cells.

The effect is realized mainly as a combination of anxiolytic (anti-anxiety) and mild stimulating (activating) effects. It reduces or eliminates feelings of anxiety (worry, bad premonitions, fears), irritability, tension (fearfulness, tearfulness, restlessness, inability to relax, insomnia, fear), depressed mood, somatic manifestations of anxiety (muscular, sensory, cardiovascular, respiratory, gastrointestinal symptoms), autonomic disorders (dry mouth, sweating, dizziness), cognitive disorders (difficulty concentrating, weakened memory), including those arising from stress disorders (adjustment disorders).

The effect develops on the 5th-7th day of treatment. The maximum effect is achieved by the end of the 4th week of treatment and persists after the end of treatment for an average of 1-2 weeks.

It does not cause muscle weakness, drowsiness and does not have a negative effect on concentration and memory. Its use does not lead to the development of tolerance, drug dependence, or withdrawal syndrome.

Pharmacokinetics

After oral administration, it is well and rapidly absorbed from the gastrointestinal tract. C_max – 0.130±0.073 µg/ml; T_max – 0.85±0.13 h. It undergoes the “first-pass” effect through the liver, the main metabolic pathways are hydroxylation of the aromatic ring of the benzimidazole cycle and oxidation of the morpholine fragment. It is intensively distributed to well-vascularized organs, characterized by rapid transfer from the central pool (blood plasma) to the peripheral pool (highly vascularized organs and tissues).

When taken orally, the T_1/2 of fabomotizole is 0.82±0.54 h. The short T_1/2 is due to the intensive biotransformation of fabomotizole and its rapid distribution from blood plasma to organs and tissues. It is excreted mainly in the form of metabolites and partially unchanged in urine and feces. With prolonged use, it does not accumulate in the body.

Indications

Used in adults for anxiety conditions: generalized anxiety disorders; neurasthenia; adjustment disorders.

In patients with various somatic diseases: bronchial asthma; irritable bowel syndrome; systemic lupus erythematosus; coronary artery disease; arterial hypertension; arrhythmias; dermatological, oncological and other diseases.

In the treatment of: sleep disorders associated with anxiety; neurocirculatory dystonia; premenstrual syndrome; alcohol withdrawal syndrome; to facilitate the withdrawal syndrome when quitting smoking.

ICD codes

Dosage Regimen

Take orally, after meals.

The single dose is 10 mg.

The standard daily dose is 30 mg, divided into three doses.

Continue treatment for a course of 2 to 4 weeks.

If clinically indicated, a physician may increase the daily dose to 60 mg.

Under medical supervision, the treatment duration can be extended to 3 months.

Do not exceed the prescribed dose.

Discontinue use and consult a physician if adverse reactions occur.

Adverse Reactions

Possible allergic reactions.

Rarely headache, which usually resolves on its own and does not require discontinuation of fabomotizole.

Contraindications

Pregnancy, lactation (breastfeeding), children under 18 years of age, hypersensitivity to fabomotizole.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

With significant overdose and intoxication, the development of a sedative effect and increased drowsiness without manifestations of muscle relaxation is possible.

Drug Interactions

Enhances the anticonvulsant effect of carbamazepine.

Causes an increase in the anxiolytic effect of diazepam.

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

Over-the-Counter

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.