Instructions for Mebikar-Farkos capsules 300 mg No. 24
Composition
active ingredient: temgicoluril;
1 capsule contains temgicoluril 300 mg calculated on 100% dry matter;
excipients: methylcellulose, calcium stearate;
capsule shell composition: titanium dioxide (E 171), gelatin.
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules of white color, containing white or almost white powder. The powder may be compressed into a column that crumbles when touched. Heterogeneity in particle size is allowed.
Pharmacotherapeutic group
Drugs used for diseases of the nervous system.
Psychoanaleptics and other psychostimulants and nootropic drugs. Temgicoluril.
ATX code N06BX21.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug temgicoluril is close in chemical structure to the body's natural metabolites: its molecule consists of two methylated urea fragments that are part of a bicyclic structure.
MEBICAR-FARKOS has a moderate sedative (anxiolytic) effect, relieves or weakens feelings of restlessness, anxiety, fear, internal emotional tension and irritation. The sedative effect of the drug is not accompanied by muscle relaxation and impaired coordination of movements. The drug does not reduce mental and motor activity, so MEBICAR-FARKOS can be used during the working day or during study. The drug does not create an elevated mood, a feeling of euphoria. On this basis, MEBICAR-FARKOS is classified as a daytime tranquilizer. It does not exhibit a hypnotic effect, but enhances the effect of hypnotics and improves sleep when it is disturbed.
In addition to its sedative effect, MEBICAR-FARKOS has a nootropic effect. The drug improves cognitive functions, increases attention and mental performance, without stimulating the symptoms of productive psychopathological disorders - delusions, pathological emotional activity.
MEBICAR-FARKOS has antioxidant activity, therefore it acts as a membrane stabilizer, adaptogen and cerebroprotector in oxidative stress of various origins.
MEBICAR-FARKOS affects the activity of structures that are part of the limbic-reticular complex, in particular the emotional zones of the hypothalamus, and also affects all 4 main neurotransmitter systems: GABAergic, cholinergic, serotoninergic and adrenergic - promotes their balance and integration, but does not have a peripheral adrenonegative effect. The neurotransmitter profile of the drug MEBICAR-FARKOS contains a dopamine-positive component. The drug exhibits antagonistic activity against the excitation of the adrenergic and glutamatergic systems and enhances the functioning of the inhibitory serotonin and GABAergic mechanisms of the brain. The drug has normastenic properties.
MEBICAR-FARKOS facilitates nicotine withdrawal.
Pharmacokinetics.
When administered orally, bioavailability is 77–80%; up to 40% of the drug binds to erythrocytes; the remaining 60% does not bind to blood proteins and is contained in the blood plasma in a free state, due to which the drug spreads in the body without hindrance and freely passes through membranes. The maximum concentration in the blood serum is reached in 30 minutes, the high level remains for 3–4 hours, then gradually decreases. The drug is completely excreted from the body with urine during the day, does not accumulate and is not subject to biochemical transformations in the body.
Indication
Neuroses and neurosis-like conditions accompanied by irritation, emotional lability, feelings of anxiety and fear.
To improve the tolerability of neuroleptics or tranquilizers in order to eliminate the somatovegetative and neurological side effects caused by them.
Cardialgia of various origins (not associated with ischemic heart disease).
As part of complex therapy for nicotine addiction as a means of reducing the urge to smoke.
Contraindication
Hypersensitivity to temgicoluril or to any of the excipients of the drug.
Interaction with other medicinal products and other types of interactions
MEBICAR-FARKOS can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants.
Application features
Habituation, dependence and withdrawal syndrome when using the drug MEBICAR-FARKOS have not been established.
It should be used with caution in patients with impaired liver and kidney function and patients with arterial hypotension.
Use during pregnancy or breastfeeding.
MEBICAR-FARKOS penetrates well into all tissues and body fluids.
There is insufficient data on the safety of the drug during pregnancy and breastfeeding, therefore it is not recommended for use in pregnant and nursing mothers.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Caution should be exercised when driving vehicles, as the use of the drug may cause a decrease in blood pressure and weakness.
Method of administration and doses
MEBICAR-FARKOS is administered orally, regardless of meals.
Adults are prescribed 300-600 mg 2-3 times a day. If necessary, the dose can be increased. The maximum single dose is 3 g, the maximum daily dose is 10 g.
The duration of the treatment course is from several days to 2-3 months.
For the treatment of nicotine addiction, the drug is used at a dose of 600–900 mg 3 times a day for 5–6 weeks.
No dose reduction is required for elderly patients and patients with hepatic insufficiency.
Dose adjustment has not been studied in patients with renal insufficiency. The drug should be administered with caution to such patients.
Children.
The medicine is not intended for use in children.
Overdose
MEBICAR-FARKOS is low-toxic. In case of significant overdose, side effects may be increased (including allergic reactions, dyspeptic disorders, weakness, temporary decrease in blood pressure and body temperature).
Treatment: gastric lavage and standard detoxification methods should be used.
Specific antidote is unknown.
Adverse reactions
Like all medicines, MEBICAR-FARKOS can cause side effects, although not everybody gets them.
Frequency of adverse reactions according to MedDRA (Medical Dictionary of Regulatory Activities) classification: very common (≥ 1/10); common (≥ 1/100 -
From the nervous system: rarely - dizziness.
From the cardiovascular system: rarely - decrease in blood pressure.
Gastrointestinal: rarely - dyspeptic disorders (including nausea, vomiting, diarrhea). In this case, the dose of the drug should be reduced.
From the respiratory system: rarely - bronchospasm.
Skin and subcutaneous tissue disorders: rarely - after taking large doses, allergic reactions are possible (including skin rashes, itching, urticaria, angioedema). In case of an allergic reaction, the drug should be discontinued.
General disorders: rarely - decreased body temperature, weakness. In case of a decrease in blood pressure and/or body temperature (body temperature may decrease by 1–1.5 °C), the drug should not be discontinued. Blood pressure and body temperature normalize after the end of the course of treatment.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
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 in a pack.
Vacation category
According to the recipe.
Producer
LLC "Pharmaceutical Company "FarKoS".
Location of the manufacturer and address of its place of business
Ukraine, 08290, Kyiv region, Irpin city, Gostomel town, St. Sviato-Pokrovska, 360.
