Mebikar-farkos

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEBICAR-FARKOS (MEBICAR-FARKOS)

Composition:

Active substance: tiamglinol;

1 capsule contains tiamglinol 300 mg calculated as 100 % dry substance;

Excipients: methylcellulose, calcium stearate;

Capsule shell composition: titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties: Hard gelatin capsules of white color containing a white or almost white powder. Compaction of the powder into a columnar form which disperses upon touch is permitted. Inhomogeneity in particle size is allowed.

Pharmacotherapeutic group

Agents used in diseases of the nervous system.

Psychoanaleptics and other psychostimulants and nootropic medicinal agents. Tiamglinol.

ATC code N06B X21.

Pharmacological Properties

Pharmacodynamics

The active ingredient of the medicinal product MEBICAR-FARKOS is chemically similar to natural metabolites of the body: its molecule consists of two methylated fragments of urea incorporated into a bicyclic structure.

MEBICAR-FARKOS exerts a tranquilizing (anxiolytic) effect, relieving or reducing feelings of uneasiness, anxiety, fear, inner emotional tension, and irritability. The calming effect of the drug is not accompanied by myorelaxation or impaired motor coordination. The medicinal product does not reduce mental or physical activity; therefore, MEBICAR-FARKOS can be used during working hours or while studying. The drug does not produce mood elevation or feelings of euphoria. For this reason, MEBICAR-FARKOS is classified as a daytime tranquilizer. It does not have a hypnotic effect, but it enhances the action of sedative-hypnotic agents and improves sleep when disturbed.

In addition to its anxiolytic effect, MEBICAR-FARKOS exerts nootropic activity, reducing undesirable side effects caused by neuroleptics and benzodiazepine-class tranquilizers (emotional depression, excessive sedation, muscle weakness).

The drug improves cognitive functions, enhances attention and mental performance, without stimulating symptomatology of productive psychopathological disorders—such as delusions or pathological emotional activity.

MEBICAR-FARKOS affects the activity of structures within the limbic-reticular complex, particularly the emotiogenic zones of the hypothalamus, and also influences all four major neurotransmitter systems: GABAergic, cholinergic, serotonergic, and adrenergic—promoting their balance and integration, without exerting peripheral adrenonegative effects. The neurotransmitter profile of MEBICAR-FARKOS includes a dopamine-positive component. The drug exhibits antagonistic activity against adrenergic and glutamatergic system excitation, while enhancing inhibitory serotonergic and GABAergic mechanisms in the brain. The medicinal product possesses normasthenic properties.

MEBICAR-FARKOS has anti-alcohol effects. In patients with alcoholism, plasma levels of endogenous ethanol are reduced, which is one of the reasons for increased alcohol craving. MEBICAR-FARKOS increases endogenous alcohol levels more effectively than other tranquilizers, thereby reducing alcohol craving.

MEBICAR-FARKOS alleviates nicotine withdrawal symptoms.

Pharmacokinetics

After oral administration, bioavailability ranges from 77% to 80%; up to 40% of the drug binds to erythrocytes; the remaining 60% remains unbound to plasma proteins and circulates freely in blood plasma, allowing unrestricted distribution throughout the body and free passage across membranes. The volume of distribution is 0.9 L/kg. Maximum serum concentration is reached within 30 minutes, with high levels maintained for 3–4 hours, followed by a gradual decline. The drug is completely eliminated from the body within 24 hours (55–70% excreted in urine), the remainder being excreted unchanged in feces. It does not accumulate in the body and does not undergo biochemical transformation.

Clinical characteristics

Indications

MEBICAR-FARKOS is intended for use in adults.

Neuroses and neurosis-like conditions (anxiety, emotional lability, worry, and fear).

For improving tolerance of neuroleptics or tranquilizers.

Non-cardiac chest pain of various origins (not related to ischemic heart disease).

As part of complex therapy for nicotine dependence, as an agent reducing smoking craving.

Contraindications

Hypersensitivity to temgicoluril or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interactions

MEBICAR-FARKOS can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants, and psychostimulants.

Special precautions for use

Dependence, addiction, and withdrawal syndrome have not been established with the use of MEPIKAR-FARKOS.

Use with caution in patients with impaired liver or kidney function and in patients with arterial hypotension.

There have been isolated reports of acute hypersensitivity reactions.

Use during pregnancy or breastfeeding

MEPIKAR-FARKOS penetrates well into all tissues and body fluids.

There is insufficient data on the safety of using this medicinal product during pregnancy or breastfeeding; therefore, it is not recommended for use in pregnant women or nursing mothers.

Ability to affect reaction speed when driving or operating machinery

Caution is advised when driving or operating machinery, since the use of this medicinal product may cause decreased arterial pressure and weakness.

Method of Administration and Dosage

MEBICAR-FARCOSS should be administered orally, independent of food intake.

For adults, the recommended dose is 300–600 mg 2–3 times daily. The dose may be increased if necessary. The maximum single dose is 3 g; the maximum daily dose is 10 g.

The duration of treatment ranges from several days to 2–3 months.

For the treatment of nicotine dependence, administer 600–1000 mg daily for 5–6 weeks (to achieve this dosage regimen, appropriate dosage forms containing the corresponding amount of active substance must be used).

Dosage adjustment is not required for elderly patients or patients with hepatic insufficiency.

Dosage adjustment in patients with renal insufficiency has not been studied. The medicinal product should be prescribed with caution in such patients.

Children

The drug is not intended for use in children.

Overdose

MEBICAR-FARCOSS has low toxicity. In cases of significant overdose, adverse effects may intensify (including allergic reactions, dyspeptic disorders, weakness, temporary reduction in blood pressure and body temperature).

Treatment: gastric lavage should be performed, along with generally accepted detoxification methods and symptomatic therapy.

There is no known specific antidote.

Side effects

MEBICAR-FARKOS, like other medicinal products, may cause adverse reactions, although they do not occur in all patients.

Frequency of adverse reactions according to the MedDRA classification (Medical Dictionary for Regulatory Activities): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Nervous system disorders: rare — dizziness.

Cardiovascular system disorders: rare — decreased blood pressure.

Gastrointestinal disorders: rare — dyspeptic disorders (including nausea, vomiting, diarrhea). In such cases, the dose of the medicinal product should be reduced.

Respiratory system disorders: rare — bronchospasm.

Skin and subcutaneous tissue disorders: rare — allergic reactions (including skin rashes, pruritus, urticaria, angioneurotic edema) may occur after taking high doses. In case of an allergic reaction, the drug should be discontinued.

General disorders: rare — decreased body temperature, weakness. If blood pressure and/or body temperature decreases (body temperature may decrease by 1–1.5 °C), there is no need to discontinue the drug. Blood pressure and body temperature will normalize after completion of the treatment course.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life

30 months.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

12 or 10 capsules in a blister, 2 blisters per carton.

Prescription status

Prescription only.

Manufacturer

LLC "Pharmaceutical Company "Farkos".

Manufacturer's address and location of business activity

360 Sviato-Pokrovska Street, settlement of Hostomel, Irpin, Kyiv region, 08290, Ukraine.