Instructions Benzonal IS tablets 0.1 g blister No. 50
Composition
active ingredient: benzobarbital;
1 tablet contains benzobarbital 50 mg or 100 mg;
excipients: lactose monohydrate, potato starch, calcium stearate, gelatin, croscarmellose sodium.
Dosage form
Pills.
Main physicochemical properties: white tablets, flat-cylindrical in shape with a bevel; on one side of the tablet there is a trademark of the company, on the other side there is a score (a tablet with a dosage of 50 mg contains a score for division into two equal doses).
Pharmacotherapeutic group
Antiepileptics. Barbiturates and their derivatives. ATX code N03A A.
Pharmacological properties
Pharmacodynamics
Benzobarbital has an anticonvulsant effect, acts as an enzyme inducer, increases the activity of the monooxygenase enzyme system of the liver. It has practically no hypnotic effect.
Pharmacokinetics
Benzobarbital is rapidly metabolized in the body, releasing phenobarbital, which exhibits an antiepileptic effect. The connection with plasma proteins is weak. It is evenly distributed in various organs and tissues. It penetrates through histohematological barriers and into breast milk. It is metabolized by microsomal enzymes. It is released slowly. It accumulates. The half-life is 3-4 days. It is excreted by the kidneys both in unchanged form and in the form of metabolites.
Indication
Various forms of epilepsy. Treatment of nonconvulsive and polymorphic epileptic seizures in combination with other antiepileptic drugs.
Contraindication
Hypersensitivity to the components of the drug. Severe parenchymal liver damage, kidney damage with impaired function, cardiac decompensation, anemia, bronchial asthma, respiratory failure, chronic alcoholism, drug addiction, myasthenia gravis, porphyria, diabetes mellitus, hyperthyroidism, adrenal insufficiency, hyperkinesia, depressive states, depressive states with suicidal attempts. Pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
Enhances the effect of narcotic analgesics, general anesthetics, neuroleptics, tranquilizers, tricyclic antidepressants, ethanol, hypnotics, reduces the effect of paracetamol, anticoagulants, tetracyclines, griseofulvin, glucocorticosteroids, mineralocorticoids, cardiac glycosides, quinidine, vitamin D, xanthines.
Benzobarbital is capable of enhancing the activity of the monooxygenase enzyme system of the liver, which should be taken into account when used simultaneously with other drugs due to a possible decrease in the effectiveness of the latter.
Application features
The decision to treat patients with epilepsy with Benzonal IC® is made by the doctor, taking into account the course of the disease, the patient's condition and the effectiveness of previous antiepileptic therapy. In patients who have previously taken barbiturates, sleep disturbances may occur during treatment with Benzonal IC®. In these cases, phenobarbital (50-100 mg) or other hypnotics can be prescribed at night.
During treatment, the consumption of alcoholic beverages is prohibited.
If you suddenly stop taking the medicine, withdrawal syndrome may occur.
Patients with known intolerance to some sugars should consult their doctor before taking this medicinal product.
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 is contraindicated during pregnancy.
If necessary, use of the drug should stop breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, you should refrain from driving or working with other mechanisms.
Method of administration and doses
The drug is taken orally after meals. The dose is set by the doctor individually. The dose of the drug depends on the patient's age, the nature and frequency of seizures. For adults, a single dose is 100-200 mg, the maximum daily dose is 800 mg. Most often, the drug can be used at 100 mg 3 times a day. Treatment should be started with a single dose. After 2-3 days, the dose should be increased until a clinical effect is achieved (reduction in frequency or complete absence of seizures). Treatment should be continued for a long period, at least 1-3 years (even in the absence of seizures), using one single dose per day. In case of recurrence of seizures, the previous daily dose should be returned.
Adults.
Maximum doses for adults: single dose – 300 mg, daily dose – 800 mg.
Children.
If the patient has previously used other anticonvulsant drugs, the transition to the use of benzobarbital should be gradual: first, one dose should be replaced with benzobarbital, and then (after 3-5 days) the second and third doses of the drug.
Children.
The drug in this dosage form should be used in children aged 3 years and older.
Overdose
In case of a significant overdose of the drug, there is depression of the central nervous system function (confusion, drowsiness, ataxia, dysarthria, nystagmus, in severe cases - coma), tachycardia, arrhythmias, decreased blood pressure, impaired renal function, and depression of the respiratory center.
Symptoms of intoxication: headache, lethargy or excitement, increased or decreased body temperature, shortness of breath, tachycardia or bradycardia, constriction of the pupils, hemorrhages on the skin in places of compression, pulmonary edema. In chronic intoxication - irritability, weakening of the ability to make critical assessments, sleep disturbances, confusion.
Treatment: gastric lavage with the use of absorbents. In case of severe poisoning, the patient should be hospitalized, forced diuresis and hemodialysis are indicated; in case of central hypoventilation, artificial ventilation of the lungs is required. Therapy is symptomatic.
Adverse reactions
From the respiratory system: bronchospasm;
Cardiovascular system: decreased blood pressure;
from the nervous system: drowsiness, lethargy, headache, decreased appetite, lethargy, difficulty speaking, ataxia;
on the part of the psyche: slowing down of mental reactions;
from the blood system: thrombocytopenia, anemia, thrombophlebitis;
from the digestive tract: diarrhea, constipation;
Skin: allergic reactions, including skin rashes;
general disorders: with prolonged use, the development of drug dependence is possible; with sudden cessation of benzobarbital therapy - withdrawal syndrome, nystagmus.
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; 3 blisters (for 50 mg dosage) or 5 blisters (for 100 mg dosage) in a pack.
Vacation category
According to the recipe.
Producer
Additional Liability Company "INTERCHEM".
Location of the manufacturer and its business address
Ukraine, 65080, Odesa region, Odessa, Lustdorfska road, building 86.
