Instructions for use Bafazol IC tablets 10 mg No. 40
Composition
active ingredient: fabomotizol;
1 tablet contains fabomotizole dihydrochloride 10 mg;
excipients: potato starch, microcrystalline cellulose, StarLac® (lactose monohydrate, corn starch), talc, colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets are white or white with a creamy tint, flat-cylindrical in shape with a bevel; color heterogeneity is allowed; the company's trademark is applied on one surface of the tablet, and a line is applied on the other surface of the tablet.
Pharmacotherapeutic group
Drugs affecting the nervous system. Psycholeptics. Anxiolytics. Other anxiolytics. Fabomotizol. ATX code N05B X04.
Pharmacological properties
Pharmacodynamics
Fabomotizol is a selective non-benzodiazepine anxiolytic.
By acting on σ1 receptors in nerve cells of the brain, fabomotizol stabilizes GABA/benzodiazepine receptors and restores their sensitivity to endogenous inhibitory mediators. Fabomotizol also increases the bioenergetic potential of neurons and has a neuroprotective effect: it restores and protects nerve cells.
The action of fabomotizol is realized mainly by a combination of anxiolytic (anti-anxiety) and mild stimulating (activating) effects. Fabomotizol reduces or eliminates feelings of anxiety (worry, bad forebodings, fears), irritability, tension (restlessness, tearfulness, feelings of anxiety, inability to relax, insomnia, fear), depressed mood, somatic manifestations of anxiety (muscular, sensory, cardiovascular, respiratory, gastrointestinal symptoms), autonomic disorders (dry mouth, increased sweating, dizziness), cognitive disorders (decreased concentration, memory impairment), including those arising from stress disorders (adaptation disorders). The use of the drug is especially indicated for individuals with predominantly asthenic personality traits in the form of anxious distrust, insecurity, increased vulnerability and emotional lability, and a tendency to emotional and stressful reactions.
The effect of the drug develops on the 5th–7th day of treatment. The maximum effect is achieved at the end of the 4th week of treatment and persists after the end of treatment for an average of 1–2 weeks.
The drug does not cause muscle weakness, drowsiness, and does not negatively affect concentration and memory. Its use does not cause addiction, drug dependence, or withdrawal syndrome.
Pharmacokinetics
Absorption
Fabomotizol is well and rapidly absorbed from the gastrointestinal tract after oral administration.
The maximum concentration of fabomotizol in blood plasma (Cmax) is 0.130±0.073 μg/ml, the time to reach maximum concentration (Tmax) is 0.85±0.13 hours.
Metabolism
Fabomotizol undergoes the first-pass effect through the liver, the main routes of metabolism are hydroxylation on the aromatic ring of the benzimidazole cycle and oxidation on the morpholine fragment.
Distribution
Fabomotizol is intensively distributed in well-vascularized organs, it is characterized by rapid transfer from the central pool (blood plasma) to the peripheral (highly vascularized organs and tissues).
Breeding
The half-life of fabomotizol after oral administration is 0.82±0.54 hours. The short half-life is due to the intensive biotransformation of fabomotizol and its rapid distribution from blood plasma to organs and tissues. Fabomotizol is excreted mainly in the form of metabolites, partly unchanged in the urine and feces.
With prolonged use, it does not accumulate in the body.
Indication
The drug is indicated for use in adults for the treatment of anxiety disorders: generalized anxiety disorder, neurasthenia, adaptation disorders, patients with various somatic diseases (bronchial asthma, irritable bowel syndrome, systemic lupus erythematosus, ischemic heart disease, arterial hypertension, arrhythmias), dermatological, oncological and other diseases.
The drug is used to treat sleep disorders associated with anxiety; neurocirculatory dystonia, premenstrual syndrome, alcohol withdrawal syndrome, and to relieve withdrawal syndrome when quitting smoking.
Contraindication
Individual intolerance to any of the components of the drug. Galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. Pregnancy and breastfeeding. Children under 18 years of age.
Interaction with other medicinal products and other types of interactions
Fabomotizol does not interact with ethanol, does not affect the hypnotic effect of thiopental. Enhances the anticonvulsant effect of carbamazepine. Causes an increase in the anxiolytic effect of diazepam.
Application features
Due to the lactose content, the medicinal product should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy is contraindicated.
Breastfeeding should be discontinued during the period of use of the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not have a negative effect on the ability to drive vehicles and the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
Apply internally after meals.
The optimal single dose is 10 mg, the daily dose is 30 mg, which should be divided into 3 doses during the day. The duration of the treatment course is 2–4 weeks.
If necessary, on the recommendation of a doctor, the daily dose of the drug can be increased to 60 mg, and the duration of treatment can be up to 3 months.
Children
The use of the drug in children under 18 years of age is contraindicated.
Overdose
In case of significant overdose and intoxication, the development of a sedative effect and increased drowsiness without manifestations of muscle relaxation is possible.
Treatment. As emergency therapy, caffeine, 20% solution for injection, 1 ml 2–3 times a day subcutaneously should be used.
Side effects
Allergic reactions are possible.
Rarely – headache, which usually resolves on its own and does not require discontinuation of the medication.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
20 tablets in a blister; 2 or 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
Additional Liability Company "INTERCHEM".
Address
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
