Corvaltab tablets №20

Corvaltab (CORVALTAB) instructions for use

Composition:

active substances: ethyl ester of α-bromoisovaleric acid, phenobarbital, mint oil; 1 tablet contains ethyl ester of α-bromoisovaleric acid - 8.2 mg; phenobarbital - 7.5 mg; Mint oil - 0.58 mg;
auxiliary substances: β-cyclodextrin, potato starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

Dosage form.

Pills.

Basic physical and chemical properties.

Tablets of white or almost white color with impregnations, round shape, with a flat surface and chamfers, with a specific odor.

Pharmacotherapeutic group.

Sleeping pills and sedatives. ATX Code N05C B02.

Pharmacological properties.

Sedative, vasodilating, 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-bromoisovaleric acid, which is part of the preparation, has a sedative and spasmolytic effect, similar to the action of a valerian extract; in large doses also has a mild hypnotic effect. Phenobarbital has a sedative and moderate spasmolytic effect. Mint oil has a reflex vasodilator and spasmolytic effect.

Clinical characteristics.

Indications.

• Neuroses with increased irritability;
• insomnia;
• in the complex therapy of hypertension and vegetovascular dystonia;
• indistinctly expressed spasms of the coronary vessels, tachycardia;
• spasms of the intestine due to neurovegetative disorders (as an antispasmodic drug).

Contraindications.

• Hypersensitivity to the components of the drug;
• severe violations of the liver and / or kidney function;
• hepatic porphyria;
• severe heart failure.

Medicines containing phenobarbital are contraindicated in severe arterial hypotension, acute myocardial infarction, diabetes mellitus, depression, myasthenia gravis, alcoholism, drug and drug dependence, respiratory diseases with dyspnea, obstructive syndrome.

Interaction with other drugs and other types of interactions.

During the simultaneous administration of the drug with other drugs that depress the central nervous system, it is possible to mutually reinforce the action. The effect of the drug is enhanced by the use of drugs valproic acid, alcohol. Phenobarbital induces liver enzymes and, accordingly, can accelerate the metabolism of certain drugs that are metabolized by liver enzymes (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral sugar-lowering, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive drugs, etc.).

Phenobarbital enhances the action of analgesics and local anesthetics.

MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.

With the simultaneous administration of phenobarbital with gold preparations, the risk of kidney damage increases.

With prolonged simultaneous use of phenobarbital with non-steroidal anti-inflammatory drugs, there is a risk of stomach ulcers and bleeding.

Simultaneous 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.

When taking the drug should avoid drinking alcohol.

The presence of phenobarbital in the drug may lead to the risk of Stevens-Johnson and Lyell syndrome, which is likely in the first weeks of treatment. Long-term use is not recommended because of the danger of developing drug dependence, the possible accumulation of bromine in the body and the development of bromine poisoning. In cases where pain in the heart does not go away after taking the drug, you need to see a doctor to exclude acute coronary syndrome. You should carefully prescribe the drug for arterial hypotension, hyperkinesia, hyperthyroidism, adrenal hypofunction, acute and persistent pain, acute drug intoxication.

The drug contains lactose, therefore, patients with hereditary intolerance to lactose-galactose should not use Corvaltab.

Use during pregnancy or lactation.

The drug should not be given to pregnant women and during breastfeeding.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Corvaltab may cause drowsiness and dizziness, therefore during the treatment period it is not recommended for patients to work with dangerous mechanisms and drive vehicles.

Method of administration and dose.

Dosage and duration of the course of treatment are set by the doctor individually for each patient.

Adults, as a rule, appoint 1-2 tablets of the drug 2-3 times a day before meals.

With tachycardia and spasms of coronary vessels, a single dose can be increased to 3 tablets.

Children.

Experience of application in the treatment of children is absent, so the drug is not used in pediatric practice.

Overdose.

Overdose is possible with frequent or prolonged use of the drug, which is due to the cumulation of its components. Long and constant use can lead to dependence, withdrawal syndrome, psychomotor agitation.

Symptoms of an overdose: respiratory depression, until it stops; depression of the central nervous system, up to coma; oppression of cardiovascular activity, including rhythm disturbance, lowering of arterial pressure up to the kolaptoid state; nausea, weakness, decreased body temperature, decreased diuresis.

Treatment: symptomatic.

Adverse reactions.

Corvaltab, as a rule, is well tolerated.

In some cases, such side effects can occur:

• from the digestive system: constipation, a feeling of heaviness in the epigastric region, with prolonged use - a violation of liver function, nausea, vomiting;
• from the side of the nervous system: weakness, ataxia, disruption of movement coordination, nystagmus, hallucinations, paradoxical agitation, decreased concentration, fatigue, retardation of reactions, headache, cognitive impairment, confusion, drowsiness, mild dizziness;
• from the hematopoietic system: anemia, thrombocytopenia, agranulocytosis;
• from the cardiovascular system: arterial hypotension, bradycardia;
• from the immune system: hypersensitivity reactions, including angioedema, allergic reactions (including skin rash, itching, urticaria);
• from the skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis;
• from the musculoskeletal system: with prolonged use of funds that contain phenobarbital there is a risk of osteogenesis.
• other: difficulty breathing.

Prolonged intake of drugs containing bromine can lead to bromine poisoning, which is characterized by: central nervous system depression, depressive mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne or purpura.

These phenomena occur with a lower dose or discontinuation of the drug.

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 pack of cardboard.

Category of vacation.

Recipe No. 10 and No. 10 × 2.

Recipe No. 10x10