COPBALTAB
(CORVALTAB)
Storage:
active substances: α-bromizovaleric acid ethyl ester, phenobarbital, peppermint oil;
1 tablet contains ethyl ester of α-bromizovaleric acid - 8.2 mg; phenobarbital - 7.5 mg; peppermint oil - 0.58 mg;
Excipients: β-cyclodextrin, potato starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate.
Dosage form. Tablets.
Basic physical and chemical properties: tablets of white or almost white color with specks, round shape, with a flat surface and chamfers, with a specific smell.
Pharmacotherapeutic group.
Hypnotics and sedatives.
ATX code N05C B02.
Pharmacological properties.
Sedative, vasodilator, antispasmodic. Helps reduce the excitability of the central nervous system, has a calming effect and facilitates the onset of natural sleep. The ethyl ester of α-bromizovaleric acid, which is part of the drug, has a sedative and antispasmodic effect, similar to the action of valerian extract; in large doses also causes a mild hypnotic effect. Phenobarbital has a sedative and moderate antispasmodic effect. Peppermint oil has a reflex vasodilating and antispasmodic effect.
Clinical characteristics.
Indication.
- Neuroses with increased irritability;
- insomnia;
- in the complex therapy of hypertension and vascular dystonia;
- mild coronary spasms, tachycardia;
- intestinal spasms caused by neurovegetative disorders (as an antispasmodic drug).
Contraindication.
- Hypersensitivity to the components of the drug;
- severe liver and / or kidney dysfunction;
- hepatic porphyria;
- severe heart failure.
Phenobarbital-containing drugs are contraindicated in severe hypotension, acute myocardial infarction, diabetes, depression, myasthenia gravis, alcoholism, drug and drug dependence, respiratory diseases with shortness of breath, obstructive syndrome.
Interaction with other drugs and other types of interactions.
At simultaneous use of drug with other medicines suppressing the central nervous system, mutual strengthening of action is possible. The effect of the drug is enhanced by the use of drugs of valproic acid, alcohol. Phenobarbital induces liver enzymes and, accordingly, may accelerate the metabolism of certain drugs metabolized by liver enzymes (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, cytotropic, perotrophic, medicines, etc.).
Phenobarbital enhances the action of analgesics and local anesthetics.
MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.
Concomitant use of phenobarbital with gold drugs increases the risk of kidney damage.
With long-term concomitant use of phenobarbital with nonsteroidal anti-inflammatory drugs there is a risk of gastric ulcer and bleeding.
Concomitant use of phenobarbital with zidovudine increases the toxicity of both drugs.
The drug increases the toxicity of methotrexate.
Features of application.
During treatment with the drug is not recommended to engage in activities that require increased attention, rapid mental and motor reactions.
Alcohol should be avoided while taking the drug.
The presence of phenobarbital in the drug may lead to the development of Stevens-Johnson syndrome and Lyell's syndrome, which is most likely in the first weeks of treatment. Prolonged use is not recommended due to the risk of drug dependence, possible accumulation of bromine in the body and the development of bromine poisoning. In cases where the pain in the heart does not go away after taking the drug, it is necessary to consult a doctor to rule out acute coronary syndrome. The drug should be used with caution in hypotension, hyperkinesis, hyperthyroidism, adrenal hypofunction, acute and persistent pain, acute drug intoxication.
Penapam contains lactose, so Corvaltab is not recommended for patients with hereditary lactose intolerance.
Use during pregnancy or breastfeeding.
The drug should not be prescribed during pregnancy and breastfeeding.
Ability to influence the speed of reaction when driving a car or other machinery.
Corvaltab may cause drowsiness and dizziness, so it is not recommended that patients use dangerous machinery or drive during treatment.
Method of application and dosage.
The dosage and duration of treatment is determined by the doctor individually for each patient.
Adults, as a rule, are prescribed 1-2 tablets of the drug 2-3 times a day before meals.
At tachycardia and spasms of coronary vessels the single dose can be increased to 3 tablets.
Children.
There is no experience in the treatment of children, so the drug should not be used in pediatric practice.
Overdose.
Overdose is possible with frequent or long-term use of the drug, which is associated with the accumulation of its components. Long-term and constant use can lead to addiction, withdrawal syndrome, psychomotor arousal.
Symptoms of overdose: respiratory depression, up to its cessation; depression of the central nervous system, up to coma; suppression of cardiovascular activity, including arrhythmia, lowering blood pressure, up to colaptoid state; nausea, weakness, decreased body temperature, decreased diuresis.
Treatment: symptomatic.
Adverse reactions.
Corvaltab is generally well tolerated.
In some cases, the following side effects may occur:
from the digestive system: constipation, heaviness in the epigastric region, with prolonged use - liver dysfunction, nausea, vomiting;
from the nervous system: weakness, ataxia, incoordination, nystagmus, hallucinations, paradoxical agitation, decreased concentration, fatigue, slow reactions, headache, cognitive impairment, confusion, drowsiness, lightheadedness;
from hematopoietic organs: anemia, thrombocytopenia, agranulocytosis;
from the cardiovascular system: hypotension, bradycardia;
on the part of the immune system: hypersensitivity reactions, including angioneurotic edema, allergic reactions (including skin rash, pruritus, urticaria);
from the skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis;
from the musculoskeletal system: with long-term use of products containing phenobarbital there is a risk of osteogenesis;
other: difficulty breathing.
Prolonged use of bromine-containing drugs can lead to bromine poisoning, which is characterized by the following symptoms: central nervous system depression, depressed mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne or purpura.
These phenomena occur after dose reduction or discontinuation of the drug.
Expiration date. 2 years.
Storage conditions. Store out of reach of 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.
Vacation category. Without a prescription - № 10 and № 10 × 2. According to the recipe - № 10 × 10.
Producer. Acino, Switzerland.
Subdivision Acino Ukraine.
