Instructions for use Tranquilar IS tablets 0.3 g blister No. 20
Composition
active ingredient: temgicoluril;
1 tablet contains temgicoluril 300 mg (0.3 g);
excipients: methylcellulose, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: white tablets, flat-cylindrical in shape, with a bevel; on one surface of the tablet there is a trademark of the company, on the other surface of the tablet there is a line.
Pharmacotherapeutic group
Psychostimulants, drugs used for attention deficit hyperactivity disorder (ADHD), and nootropics. Other psychostimulants and nootropics. Temgicoluril.
ATX code N06B X21.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug temgicoluril is close in chemical structure to the body's natural metabolites: the temgicoluril molecule consists of two methylated urea fragments that are part of a bicyclic structure.
Tranquilar® IS acts on the activity of the structures of the limbic-reticular complex, in particular on the emotional zones of the hypothalamus, and also affects all 4 main neurotransmitter systems - GABAergic, cholinergic, serotoninergic and adrenergic, which contributes to their balance and integration, but does not have a peripheral adrenonegative effect. Tranquilar® IS 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 neurotransmitter profile of the drug contains a dopamine-positive component.
The drug has normostenic properties.
Tranquilar® IS has moderate tranquilizing (anxiolytic) activity, relieves or reduces feelings of anxiety, anxiety, fear, internal emotional tension and irritation. The anxiolytic 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 it can be used during the working day or during study. On this basis, Tranquilar® IS is classified as a daytime tranquilizer. The drug does not exhibit a hypnotic effect, but enhances the effect of hypnotics and improves sleep when it is disturbed.
In addition to the anxiolytic effect, the drug has a nootropic effect. Tranquilar® IS improves cognitive functions, increases attention and mental performance, without stimulating the symptoms of productive psychopathological disorders, such as delusions, pathological emotional activity.
The drug reduces the severity of side effects (emotional suppression, hypersedation, muscle weakness) caused by neuroleptics and benzodiazepine tranquilizers.
The drug has an anti-alcohol effect. In patients with alcoholism, one of the reasons for increased craving for alcohol is a reduced level of endogenous ethyl alcohol in the blood plasma. Tranquilar® IC, by increasing the level of endogenous ethyl alcohol (to a greater extent than other tranquilizers), reduces craving for alcohol.
Tranquilar® IC eases nicotine withdrawal.
The medicine does not create an elevated mood or a feeling of euphoria.
Pharmacokinetics.
When administered orally, bioavailability is 77–80%; up to 40% of temgikoluril 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 temgikoluril is freely distributed in the body and freely passes through membranes. The volume of distribution is 0.9 l/kg. The maximum concentration of temgikoluril in the blood serum is reached in 30 minutes, the high level is maintained for 3–4 hours, then gradually decreases. Temgikoluril is completely excreted from the body: 55‒70% of the dose of the drug is excreted in the urine, the rest - with feces in an unchanged form during the day. Temgikoluril does not accumulate and is not subject to biochemical transformations in the body.
Indication
The medicine is intended for use by adults.
Neuroses and neurosis-like conditions accompanied by feelings of anxiety and fear, emotional lability, and a state of restlessness.
Cardialgia of various origins (not related to ischemic heart disease).
To improve the tolerability of neuroleptics and tranquilizers.
Use as part of a comprehensive treatment 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
Tranquilar® IS can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants.
Application features
Habituation, development of dependence and withdrawal syndrome when using temgicoluril have not been established.
The drug should be used with caution in cases of arterial hypotension, liver and kidney dysfunction.
There have been isolated reports of acute hypersensitivity reactions.
Use during pregnancy or breastfeeding
There is insufficient data on the safety of temgicoluril during pregnancy and breastfeeding, therefore, the drug is not recommended for pregnant and breastfeeding women.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving vehicles, as the use of temgicoluril may cause a decrease in blood pressure and weakness.
Method of administration and doses
The drug should be taken orally, regardless of meals. The dosage depends on the individual characteristics of the patient and the therapeutic purpose of the drug.
The usual dose for adults is 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 course of treatment is from several days to 2–3 months.
As part of a comprehensive treatment for nicotine addiction, the drug should be used at a dose of 600–900 mg per day daily for 5–6 weeks.
For elderly patients and patients with liver failure, the dose of the drug does not need to be reduced.
Dose adjustment has not been studied in patients with renal insufficiency. The drug should be administered with caution to such patients.
If one or more times the next dose has not been taken on time, the course of treatment should be continued according to the previously prescribed regimen.
Children.
The medicine is not intended for use in children.
Overdose
The drug is low-toxic. In case of a significant overdose, side effects may increase (including allergic reactions, dyspeptic disorders, weakness, temporary decrease in blood pressure and body temperature).
Treatment: gastric lavage should be performed and standard detoxification methods and symptomatic therapy should be used.
No specific antidote is known.
Side effects
Like all medicines, Tranquilar® IS can cause side effects, although not everybody gets them.
Adverse drug reactions are classified by system organ class and frequency. The frequency is defined as follows: 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), not known (cannot be estimated from the available data).
From the nervous system: rarely - dizziness.
From the cardiovascular system: rarely - a decrease in blood pressure.
Gastrointestinal: rarely - dyspeptic disorders (including nausea, vomiting, diarrhea). In this case, the dose of the drug should be reduced.
On the part of the respiratory system: rarely - bronchospasm.
Skin and subcutaneous tissue disorders: rarely - allergic reactions (including skin rash, itching, urticaria, angioedema). In case of an allergic reaction, the drug should be discontinued.
General disorders: rarely - decreased body temperature, weakness. In case of decreased 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 of the 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
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
Additional Liability Company "INTERCHEM".
Location of the manufacturer and address of its place of business
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
