Corvaltab

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOPBALTAB (CORVALTAB)

Composition:

Active substances: ethyl ether of α-bromoisovaleric acid, phenobarbital, peppermint oil;

1 tablet contains ethyl ether of α-bromoisovaleric acid – 8.2 mg; phenobarbital – 7.5 mg; peppermint oil – 0.58 mg;

Excipients: β-cyclodextrin, potato starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white or almost white tablets with specks, flat-surfaced, round with bevelled edge, with a characteristic odour.

Pharmacotherapeutic group.

Hypnotics and sedatives.

ATC code N05C B02.

Pharmacological properties.

A sedative, vasodilatory, and spasmolytic agent. It helps reduce excitability of the central nervous system, exerts a calming effect, and facilitates the onset of natural sleep. Ethyl ether of α-bromoisovaleric acid, included in the drug formulation, produces sedative and spasmolytic effects similar to those of valerian extract; at higher doses, it also causes a mild hypnotic effect. Phenobarbital exerts sedative and moderate spasmolytic actions. Peppermint oil produces reflex vasodilatory and spasmolytic effects.

Clinical characteristics.

Indications.

• Neuroses with increased irritability;
• insomnia;
• as part of combination therapy for hypertension and vegetative-vascular dystonia;
• mild coronary vessel spasms, tachycardia;
• intestinal spasms due to neurovegetative disorders (as a spasmolytic agent).

Contraindications.

Hypersensitivity to the components of the drug; severe impairment of liver and/or kidney function; acute hepatic porphyria; severe heart failure, pronounced arterial hypotension, acute myocardial infarction, diabetes mellitus, depression and depressive disorders with suicidal tendencies, myasthenia gravis, alcoholism, narcotic and drug dependence, respiratory diseases with dyspnea, obstructive syndrome. Pregnancy and lactation. Pediatric age.

Interaction with other medicinal products and other types of interactions.

Phenobarbital induces liver enzymes and thus may accelerate the metabolism of certain drugs metabolized by liver enzymes (including paracetamol, salicylates, indirect anticoagulants, cardiac glycosides (digoxin), antimicrobial agents (chloramphenicol, doxycycline, metronidazole, rifampicin, sulfonamides), antiviral, antifungal (griseofulvin, itraconazole), antiepileptic, anticonvulsant, psychotropic (tricyclic antidepressants), oral hypoglycemic, hormonal (estrogens, progestogens, corticosteroids, thyroid hormones), immunosuppressive (glucocorticoids, cyclosporine, cytostatics), antiarrhythmic, antihypertensive (β-blockers, calcium channel blockers) drugs, etc.).

Phenobarbital enhances the effect of analgesics, local anesthetics, neuroleptics, and tranquilizers. Phenobarbital may accelerate the metabolism of oral contraceptives, leading to loss of their efficacy. When used concomitantly with other medicinal products that depress the central nervous system, mutual enhancement of effects is possible, which may be accompanied by respiratory depression. The effect of the drug is enhanced when used with valproic acid and alcohol. Alcohol enhances the effect of the medicinal product and may increase its toxicity. Possible influence on blood concentrations of phenytoin, as well as carbamazepine and clonazepam. The drug increases the toxicity of methotrexate. Medicinal products with acidic properties (ascorbic acid, ammonium chloride) and those containing valproic acid enhance the effect of barbiturates. Patients receiving concurrent treatment with valproate and phenobarbital should be monitored for signs of hyperammonemia. In half of the reported cases, hyperammonemia was asymptomatic and did not necessarily lead to encephalopathy. MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.

Concomitant use of phenobarbital with gold-containing preparations increases the risk of kidney damage. Prolonged concomitant use with nonsteroidal anti-inflammatory drugs increases the risk of gastric ulceration and bleeding.

Simultaneous use of phenobarbital and zidovudine enhances the toxicity of both drugs.

Special precautions for use.

During treatment with this medicinal product, activities requiring increased attention and rapid psychomotor reactions should be avoided.

Alcoholic beverages should be avoided during administration of this medicinal product.

Phenobarbital is contraindicated in depressive disorders associated with suicidal tendencies.

Life-threatening skin reactions, including Stevens–Johnson syndrome or toxic epidermal necrolysis (Lyell’s syndrome), have been reported during treatment with phenobarbital, most likely within the first weeks of therapy. Therefore, if characteristic symptoms appear (e.g. progressive skin rash, often with blistering, and mucosal lesions), the drug should be discontinued immediately and never be used again in the future. Medicinal products containing phenobarbital must not be administered thereafter. Early diagnosis and immediate discontinuation of the suspected causative drug provide the best chance for successful treatment outcomes.

Prolonged use is not recommended due to the risk of drug dependence, possible accumulation of bromide in the body, and bromide poisoning. Barbiturates are associated with a withdrawal syndrome.

If chest pain does not subside after taking the drug, medical advice must be sought to rule out acute coronary syndrome. The drug should be prescribed with caution in patients with decompensated heart failure (see section "Contraindications"), arterial hypotension, hyperkinesia, hyperthyroidism, adrenal insufficiency, acute or persistent pain, and acute intoxication with medicinal products.

Patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product due to its lactose content.

Use during pregnancy or breastfeeding.

Pregnancy

Use of this medicinal product during pregnancy is contraindicated.

Barbiturates increase the risk of fetal abnormalities. Administration of phenobarbital during the third trimester of pregnancy may lead to physical dependence, resulting in withdrawal syndrome in the newborn, manifested by seizures, irritability, and impaired blood coagulation. Use of phenobarbital during labor may cause respiratory depression in the newborn.

Breastfeeding

Use of this medicinal product during breastfeeding is contraindicated.

Phenobarbital passes into breast milk in significant amounts and may suppress the central nervous system of the infant.

Ability to affect reaction speed when driving or operating machinery.

This medicinal product may cause impaired motor coordination, reduced psychomotor reaction speed, drowsiness, and dizziness. Therefore, during treatment, patients should avoid operating hazardous machinery and driving vehicles.

Dosage and Administration

The dosage and duration of treatment are determined individually by a physician for each patient.

For adults, the usual dose is 1–2 tablets 2–3 times daily, taken before meals.

In cases of tachycardia and coronary vessel spasm, the single dose may be increased to 3 tablets.

Children.

There is no clinical experience regarding the use of this drug in children; therefore, it should not be used in pediatric practice.

Overdose.

Overdose may occur with frequent or prolonged use of the drug due to accumulation of its components. Long-term and continuous use may lead to dependence, abstinence syndrome, and psychomotor agitation.

Symptoms of mild to moderate acute barbiturate poisoning: dizziness, increased fatigue, deep sleep from which the patient cannot be awakened. Hypersensitivity reactions may also occur: angioneurotic edema, pruritus, skin rash (including urticaria).

Symptoms of severe acute barbiturate poisoning: central nervous system depression progressing to deep coma, accompanied by tissue hypoxia; shallow respiration, initially rapid and later slowed; respiratory depression up to complete cessation; cardiovascular depression, including arrhythmias; decreased arterial pressure, up to collapse-like state; lowered body temperature, reduced diuresis, tachycardia or bradycardia, diminished or absent reflexes, nystagmus, headache, nausea, weakness.

If untreated, fatal outcome may result from circulatory failure, respiratory paralysis, or pulmonary edema.

Treatment: symptomatic therapy (primarily monitoring of vital functions: respiration, pulse, arterial pressure). Cases of acute poisoning should be managed similarly to poisoning with other sedatives and barbiturates, depending on the severity of symptoms. Patients may require intensive care. It is essential to stabilize and normalize respiration and circulation. Respiratory failure is managed by artificial ventilation; shock is treated by infusion of plasma and plasma substitutes. If a short time has passed since drug ingestion (not more than 6 hours), gastric lavage should be performed, followed by administration of an adsorbent (activated charcoal) and sodium sulfate. To accelerate elimination of barbiturates from the body, forced alkaline diuresis, hemodialysis, and/or hemoperfusion may be performed.

Prolonged use of drugs containing bromine may lead to bromine poisoning.

Symptoms of bromine poisoning: central nervous system depression, depression, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, purpura.

Treatment: elimination of bromide ions from the body can be accelerated by administration of a large volume of sodium chloride solution along with saluretic agents.

In case of hypersensitivity reactions, desensitizing drugs should be administered.

Adverse Reactions

Corvaltab is generally well tolerated.

In individual cases, the following adverse effects may occur:

Immune system disorders: hypersensitivity reactions, including angioedema, allergic reactions (e.g. skin rash, pruritus, urticaria).

Nervous system disorders: asthenia, weakness, ataxia, impaired motor coordination, nystagmus, hallucinations, paradoxical excitation, decreased attention span, fatigue, slowed reaction time, headache, cognitive disturbances, insomnia (mainly in elderly patients), confusion, somnolence, dizziness, depression.

Gastrointestinal disorders: dyspeptic symptoms including heartburn, nausea, vomiting, constipation, epigastric heaviness, stomach pain; with prolonged use – liver function disturbances.

Blood and lymphatic system disorders: anemia, thrombocytopenia, agranulocytosis, megaloblastic anemia.

Cardiovascular disorders: arterial hypotension, bradycardia.

Respiratory system disorders: dyspnea.

Skin and subcutaneous tissue disorders: increased photosensitivity (photosensitization), polymorphic exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis.

Musculoskeletal and connective tissue disorders: prolonged use of products containing phenobarbital may impair osteogenesis. Cases of decreased bone mineral density, osteopenia, osteoporosis, and fractures have been reported in patients on long-term phenobarbital therapy. The mechanism of phenobarbital’s effect on bone metabolism has not been established.

Other: increased body temperature, lymphadenopathy, leukocytosis, lymphocytosis, leukopenia, collapse.

With prolonged use of phenobarbital, folate deficiency, impotence, drug dependence, and withdrawal syndrome may develop. The withdrawal syndrome typically occurs after abrupt discontinuation of the drug and is accompanied by nightmares and nervousness.

Shelf life. 2 years.

Storage conditions. Store in a place inaccessible to children, in the original packaging at a temperature not exceeding 25 °C.

Packaging. 10 tablets in a blister; 2 and 10 blisters in a cardboard pack.

Prescription category. Over-the-counter – № 10 and № 10×2. Prescription-only – № 10×10.

Manufacturer. LLC "Pharma Start".

Manufacturer's address and location of business activity.

8 Vatslava Havela Boulevard, Kyiv, 03124, Ukraine.

If adverse effects occur or if you have any questions regarding the safety of using the medicinal product, please contact the Pharmacovigilance Department of LLC "ASINO UKRAINA" at: 8 Vatslava Havela Boulevard, Kyiv, 03124, Tel/Fax: +38 044 281 2333.