Instructions for use Carditab IS tablets blister pack No. 10
Composition
active ingredients: phenobarbital, ethyl ester of α-bromoisovaleric acid, peppermint oil;
1 tablet contains phenobarbital 7.5 mg, α-bromoisovaleric acid ethyl ester 8.2 mg, peppermint oil 0.58 mg;
excipients: β-cyclodextrin, calcium hydrogen phosphate dihydrate, StarLac® (lactose monohydrate, corn starch), mannitol (E 421), acesulfame potassium, citric acid monohydrate, sodium citrate, croscarmellose sodium, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Sublingual tablets.
Main physicochemical properties: tablets of white or almost white color, flat-cylindrical shape with a bevel; color heterogeneity is allowed; 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
Hypnotics and sedatives. Combined barbiturate preparations. ATX code N05C B02.
Pharmacodynamics
Sedative, vasodilator, antispasmodic. Helps reduce the excitability of the central nervous system, has a calming effect, facilitates the onset of natural sleep, lowers blood pressure, relieves and prevents vascular spasms, especially cardiac ones. Phenobarbital, depending on the dose, has a sedative, moderate antispasmodic or hypnotic effect due to the suppression of the activating effects of the centers of the reticular formation of the medulla oblongata on the cerebral cortex, which reduces the flow of excitatory effects on the cerebral cortex and subcortical structures. Ethyl ester of α-bromisovaleric acid has a sedative and antispasmodic effect, similar to the effect of valerian extract, caused by irritation mainly of receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central nervous system and an increase in inhibition phenomena in neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of central vasomotor centers and a direct local antispasmodic effect on the smooth muscles of blood vessels. In high doses, it also causes a mild hypnotic effect. Peppermint oil has a reflex vasodilator and antispasmodic effect due to irritation of cold receptors of the oral cavity and reflex dilation of mainly the vessels of the heart and brain. Relieves spasms of smooth muscles, has a calming, antiseptic and mild choleretic effect.
Pharmacokinetics
When administered sublingually, absorption begins in the sublingual area, the effect is manifested after 5-10 minutes. The bioavailability of the active substances is high (approximately 60-80%). In patients who have previously taken barbituric acid preparations, the duration of action of the drug is reduced due to the accelerated metabolism of phenobarbital in the liver, where barbiturates cause enzyme induction. In elderly patients and in patients with cirrhosis of the liver, the metabolism of phenobarbital is reduced, so in these patients the half-life is prolonged, which requires the need to reduce the dose and extend the intervals between taking the drug.
Indication
Neuroses with increased irritability.
Insomnia.
In the complex therapy of hypertension and vegetative-vascular dystonia.
Cardialgia, tachycardia.
Intestinal spasms caused by neurovegetative disorders (as an antispasmodic drug).
Contraindication
Hypersensitivity to the active substances or to any other component of the drug, to bromine; severe liver and/or kidney dysfunction, acute hepatic porphyria, severe heart failure, acute myocardial infarction, severe arterial hypotension, diabetes mellitus, myasthenia gravis, respiratory diseases with shortness of breath, obstructive syndrome; depression and depressive disorders with a tendency of the patient to suicidal behavior; alcoholism, drug and medication addiction (including a history). Pregnancy and breastfeeding. Children's age.
Interaction with other medicinal products and other types of interactions
Phenobarbital induces liver enzymes and thus can accelerate the metabolism of some drugs metabolized by these enzymes (including paracetamol, salicylates, indirect anticoagulants, cardiac glycosides (digitoxin), antimicrobials (chloramphenicol, doxycycline, metronidazole, rifampicin, sulfonamide), antivirals, antifungals (griseofulvin, itraconazole), antiepileptics (anticonvulsants), psychotropics (tricyclic antidepressants), hormonal (estrogens, progestogens, corticosteroids, thyroid hormones), immunosuppressives (glucocorticosteroids, cyclosporine, cytostatics), antiarrhythmics, antihypertensives (β-blockers, calcium channel blockers), oral hypoglycemic drugs, etc.). Phenobarbital enhances the effect of analgesics, anesthetics, neuroleptics, tranquilizers. Phenobarbital can accelerate the metabolism of oral contraceptives, which leads to a loss of their effect. When using the drug with other drugs that depress the central nervous system, a mutual enhancement of the effect (sedative-hypnotic effect) is possible, which may be accompanied by respiratory depression. Alcohol enhances the effect of the drug and may increase its toxicity. It may affect the concentration of phenytoin in the blood, as well as carbamazepine and clonazepam. The drug increases the toxicity of methotrexate. Drugs that have the properties of acids (ascorbic acid, ammonium chloride), and drugs containing valproic acid, enhance the effect of barbiturates. Monoamine oxidase inhibitors (MAO) prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital. When used together with gold preparations, the risk of kidney damage increases. With prolonged simultaneous use with nonsteroidal anti-inflammatory drugs, there is a risk of stomach ulcers and bleeding. Simultaneous use of phenobarbital with zidovudine increases the toxicity of both drugs.
Application features
During treatment with the drug, it is not recommended to engage in activities that require increased attention, rapid mental and motor reactions.
While taking the medicine, you should avoid drinking alcoholic beverages.
Phenobarbital is contraindicated in depressive disorders with a tendency for the patient to suicidal behavior.
Cases of life-threatening skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome), have been reported with the use of phenobarbital. Therefore, if their characteristic symptoms appear (e.g. progressive skin rash, often with blisters, and mucosal lesions), the use of Carditab IS should be discontinued and in the future, drugs containing phenobarbital should not be used in any case. The risk of developing Stevens-Johnson syndrome and Lyell's syndrome is greatest in the first weeks of treatment. Early diagnosis and immediate discontinuation of the drug that could have caused the symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis allow achieving the best results in treatment.
Long-term use of the drug should be avoided due to the possibility of phenobarbital accumulation and the development of drug dependence, as well as the risk of bromine accumulation in the body and the possible development of bromine poisoning. Barbiturates are characterized by withdrawal syndrome.
If pain in the heart area does not go away after taking the medication, you should consult a doctor to rule out acute coronary syndrome.
The drug should be used with caution in decompensated heart failure (see section "Contraindications"), bronchial asthma (see section "Contraindications"), arterial hypotension (see section "Contraindications"), hyperkinesias, hyperthyroidism, adrenal hypofunction, acute and persistent pain, acute drug intoxication.
Patients with known intolerance to some sugars should contact their doctor before taking this medicine. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine due to the lactose content.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause impaired coordination of movements, speed of psychomotor reactions, drowsiness and dizziness, therefore, during the period of treatment, patients are not recommended to work with dangerous mechanisms and drive vehicles.
Use during pregnancy or breastfeeding
Pregnancy period
The use of the drug during pregnancy is contraindicated.
Barbiturates increase the likelihood of fetal pathology. When using phenobarbital during the third trimester of pregnancy, physical dependence may occur, leading to withdrawal syndrome in the newborn, which is manifested by convulsions, agitation, and blood clotting disorders. The use of phenobarbital during labor may lead to respiratory depression in the newborn.
Breastfeeding period
Phenobarbital passes into breast milk in significant amounts and can depress the infant's central nervous system.
Method of administration and doses
The doses and duration of treatment depend on the course of the disease and are determined by the doctor individually.
Adults are usually prescribed the drug sublingually (under the tongue) 1–2 tablets 2–3 times a day before meals.
For tachycardia and coronary artery spasms (cardialgia), the single dose can be increased to 3 tablets.
Children
There is no experience with the use of the drug in the treatment of children (under 18 years of age), therefore the drug is contraindicated for patients in this age category.
Overdose
Overdose is possible with frequent or long-term use of the drug, which is associated with the cumulation of its components. Long-term continuous use can lead to the development of dependence, the appearance of withdrawal symptoms (psychomotor agitation, etc.).
Symptoms of acute poisoning with barbiturates of mild or moderate severity: dizziness, increased fatigue, even deep sleep from which the patient cannot be awakened. Hypersensitivity reactions may occur: angioedema, itching, rash (in particular urticaria).
Symptoms of acute severe barbiturate poisoning: central nervous system depression, up to deep coma, accompanied by tissue hypoxia; shallow breathing, first accelerated, then slowed breathing, respiratory depression, up to its cessation; depression of cardiovascular activity, including rhythm disturbances, decreased blood pressure, up to a collapse-like state; decreased body temperature, decreased diuresis, rapid heartbeat or bradycardia, weakened or absent reflexes, nystagmus, headache, nausea, weakness.
If poisoning is left untreated, death is possible due to vascular insufficiency, respiratory paralysis, or pulmonary edema.
Treatment: symptomatic therapy (primarily monitoring of the body's main vital functions: breathing, pulse, blood pressure). Cases of acute poisoning with the drug Karditab IS should be treated in the same way as poisoning with other hypnotics and barbiturates, depending on the severity of the symptoms of poisoning. Patients may require intensive care. It is necessary to stabilize and normalize breathing and blood circulation. Respiratory failure is overcome by artificial respiration, shock is stopped by infusion of plasma and plasma substitutes. If a short time has passed since taking the drug (no more than 6 hours), it is necessary to perform gastric lavage with subsequent administration of a sorbent (activated carbon) and sodium sulfate. In order to quickly remove the barbiturate from the body, forced diuresis with alkalis, as well as hemodialysis and/or hemoperfusion, can be performed.
Long-term use of medications containing bromine can lead to bromine poisoning.
Symptoms of bromine poisoning: central nervous system depression, depression, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, purpura.
Treatment: the elimination of bromine ions from the body can be accelerated by administering a significant amount of table salt solution with the simultaneous administration of saluretics.
If hypersensitivity reactions occur, prescribe desensitizing medications.
Adverse reactions
In some cases, the following side effects may occur:
from the immune system: hypersensitivity reactions, including angioedema, skin rash (in particular urticaria), itching; from the nervous system: asthenia, weakness, ataxia, impaired coordination of movements, nystagmus, hallucinations, paradoxical excitation, decreased concentration of attention, increased fatigue, slowed reactions, headache, cognitive disorders, insomnia (mainly in elderly patients), drowsiness, dizziness, confusion, depression; from the gastrointestinal tract: nausea, vomiting, constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function; from the hematopoietic system: thrombocytopenia, agranulocytosis, anemia, megaloblastic anemia; from the cardiovascular system: arterial hypotension, bradycardia; from the respiratory system: difficulty breathing; Skin and subcutaneous tissue disorders: increased skin photosensitivity (photosensitivity), polymorphic exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis; Musculoskeletal system: with prolonged use of drugs containing phenobarbital, there is a risk of osteogenesis disorders. There have been reports of decreased bone mineral density, osteopenia, osteoporosis, and fractures in patients receiving long-term therapy with phenobarbital. The mechanism of the effect of phenobarbital on bone metabolism has not been established.
Others: fever, lymph node enlargement, leukocytosis, lymphocytosis, leukopenia, collapse.
Prolonged use of phenobarbital may lead to folate deficiency, impotence, drug dependence, and withdrawal syndrome, which usually occurs with abrupt discontinuation of the drug and is accompanied by nightmares and nervousness.
Expiration date
3 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, 1 blister in a pack.
Vacation category
Without a prescription.
Producer
Additional Liability Company "INTERCHEM".
Location of the manufacturer and its business address
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
