Menovalen-zdorovya combi

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MENOVALEN-ZDOROV'YA KOMBI

Composition:

Active substances: 1 ml (20 drops) of the preparation contains phenobarbital 18.4 mg; ethyl ether of alpha-bromoisovaleric acid 18.4 mg;

Excipients: peppermint oil, hop oil, ethanol 96%, purified water.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: colorless liquid with an aromatic odor and bitter taste. Opalescence may occur.

Pharmacotherapeutic group. Hypnotics and sedatives. Barbiturates in combination with drugs from other groups. ATC code N05CB02.

Pharmacological Properties

Pharmacodynamics

A combination drug containing phenobarbital and ethylbromisovalerate (ethyl ether of α-bromoisovaleric acid). Depending on the dose, both of these substances exert sedative and hypnotic effects, and at high doses, narcotic effects. Like other barbituric acid derivatives, phenobarbital inhibits the inhibitory system of the reticular formation. Ethylbromisovalerate has both spasmolytic and sedative properties. Peppermint oil exerts a reflex vasodilatory and spasmolytic effect.

The drug acts as a sedative, favorably affects cardiac function, and is well tolerated by the body when the dosage prescribed by a physician is followed. Administration of the drug helps reduce central nervous system excitation and facilitates the onset of sleep.

Pharmacokinetics

Phenobarbital is rapidly absorbed (directly in the stomach). Approximately 30–60% of it is protein-bound in plasma and is distributed nearly uniformly throughout all body tissues. The half-life in plasma ranges from 48 to 144 hours. About 30% of phenobarbital is excreted unchanged in urine, while only a small portion is oxidized in the liver. With prolonged use, accumulation of the active substance in plasma occurs, as well as induction of liver enzymes. As a result of this induction, the oxidative metabolism of phenobarbital and other drugs is accelerated.

Bromide in ethylbromisovalerate is eliminated very slowly from the body. With prolonged administration, accumulation of the substance in the central nervous system (CNS) may occur, leading to chronic bromide intoxication.

Clinical characteristics.

Indications.

• Functional disorders of the cardiovascular system;
• neuroses accompanied by increased irritability and feelings of fear;
• psychosomatically induced anxiety;
• excited states with pronounced vegetative manifestations;
• sleep onset disorders.

Contraindications. Hypersensitivity to any component of the drug. Diabetes mellitus, depression, myasthenia gravis, porphyria, alcoholism, drug or narcotic dependence (including in medical history), respiratory diseases with dyspnea, obstructive syndrome, depressive disorders with tendency to suicidal behavior, severe impairment of liver or kidney function, pronounced arterial hypotension, acute myocardial infarction.

Interaction with other medicinal products and other types of interactions. When used concomitantly with other medicinal products that suppress the CNS, mutual enhancement of effects (sedative-hypnotic effect) is possible, which may be accompanied by respiratory depression. Medicinal products containing valproic acid increase the effect of barbiturates. Alcohol enhances the effect of the drug and may increase its toxicity. The drug may reduce the effect of coumarin derivatives, griseofulvin, glucocorticoids, and oral contraceptives. The drug increases the toxicity of methotrexate.

Phenobarbital induces liver enzymes and thus may accelerate the metabolism of certain drugs metabolized by these enzymes (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive medicinal products).

Phenobarbital enhances the effect of analgesics, local anesthetics, anesthetic agents, neuroleptics, tranquilizers, and alcohol; it reduces the effect of paracetamol, tetracyclines, griseofulvin, glucocorticoids, chloramphenicol, metronidazole, tricyclic antidepressants, estrogens, salicylates, and digoxin. Concurrent use of phenobarbital with other drugs exhibiting sedative effects leads to enhanced sedative-hypnotic effect and may be accompanied by respiratory depression. Medicinal products with acidic properties (ascorbic acid, ammonium chloride) enhance the effect of barbiturates. Possible influence on blood concentration of phenytoin, as well as carbamazepine and clonazepam. MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital. When used concomitantly with gold compounds, the risk of kidney damage increases. With prolonged concurrent use with nonsteroidal anti-inflammatory drugs, there is a risk of gastric ulceration and bleeding. Concurrent use of phenobarbital with zidovudine enhances the toxicity of both drugs. Phenobarbital may accelerate the metabolism of oral contraceptives, leading to loss of contraceptive effect.

Consult a physician before using this drug concomitantly with any other medicinal products.

Special precautions.

The preparation contains 55 volume percent ethanol.

The risk of developing Stevens-Johnson syndrome and Lyell's syndrome is highest during the first weeks of treatment.

Prolonged use of the preparation is not recommended due to the risk of drug dependence, possible accumulation of bromine in the body, and bromide poisoning.

Prolonged use of the preparation should be avoided due to the possibility of its accumulation and development of dependence.

If chest pain does not subside after taking the preparation, consult a physician to rule out acute coronary syndrome.

Barbiturates, like benzodiazepines, are characterized by withdrawal syndrome.

Use with caution in hyperkinesia, hyperthyroidism, adrenal hypofunction, decompensated heart failure, acute and persistent pain, and acute intoxication with medicinal agents.

Use during pregnancy or breastfeeding. The preparation is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The preparation reduces reaction speed. Patients should refrain from potentially hazardous activities requiring heightened attention and rapid mental and motor reactions.

Dosage and Administration

For adult use only.

Take orally during meals, diluting the single dose in a small amount of liquid.

The recommended dose is 15–20 drops three times daily. In patients with insomnia, the dose may be increased to 30 drops three times daily.

The duration of treatment is determined individually by a physician, depending on the clinical response and drug tolerability.

Children. There is no experience with the use of this drug in children; therefore, the drug should not be administered to children.

Overdose

Symptoms. Toxic effects may occur due to the presence of phenobarbital and ethylbromisovalerianate in the drug.

Acute poisoning with ethylbromisovalerianate may occur after a single ingestion of approximately 20 g.

Acute poisoning (from mild to moderate severity) manifests as drowsiness and confusion progressing to deep sleep.

Symptoms of severe acute poisoning may include CNS depression progressing to deep coma, shallow breathing (initially rapid, then slowed), respiratory depression that may progress to respiratory arrest, increased heart rate, depression of cardiovascular function (including cardiac arrhythmias and decreased arterial blood pressure up to collapse-like state), diminished or absent reflexes, nausea, weakness, hypothermia, and reduced diuresis.

Without emergency treatment, death may result from sudden depression of cardiovascular function, respiratory paralysis, or pulmonary edema.

If the bromide concentration in blood plasma rises to approximately 150 mg%, signs of poisoning may appear. A plasma bromide level exceeding 200 mg% is comparable to chronic bromide poisoning. Concentrations of 300–400 mg% are life-threatening and are associated with severe psychosis and stupor. With prolonged use of organic bromine compounds, bromide poisoning may develop (see section "Adverse Reactions").

Treatment. Gastric lavage (introduce 10 g of activated charcoal powder into the stomach, followed by slow administration of 2 tablespoons of sodium sulfate). To accelerate the elimination of barbiturates from the body, forced alkaline diuresis, hemodialysis, and/or hemoperfusion may be performed. Symptomatic therapy. In cases of acute poisoning, measures to support respiration and circulation should be implemented according to the severity of intoxication, and intensive medical monitoring is recommended. If necessary, artificial respiration should be instituted, and shock should be treated with blood plasma or plasma substitutes.

Treatment of bromide poisoning: elimination of bromide ions from the body can be accelerated by administration of a large amount of sodium chloride solution, combined with diuretic agents.

In case of hypersensitivity reactions, administer desensitizing medications.

Adverse Reactions.

In individual cases, drowsiness and mild dizziness may occur. Chronic bromine poisoning (bromism) may develop with prolonged use of high doses of the drug, which may manifest as: CNS depression, depressed mood, depression, apathy, ataxia, confusion, rhinitis, conjunctivitis, lacrimation, acne, purpura. Gastrointestinal disturbances and allergic reactions may also occur.

Nervous system: asthenia, dizziness, weakness, ataxia, impaired motor coordination, nystagmus, hallucinations, depression, hyperkinesia (in children), paradoxical excitement, insomnia (mainly in children and elderly patients), decreased attention span, increased fatigue, drowsiness, confusion, slowed reaction time, headache, cognitive disturbances.

Musculoskeletal system: prolonged use may carry a risk of impaired osteogenesis and development of rickets.

Gastrointestinal system: nausea, vomiting, constipation, epigastric fullness; with prolonged use – impaired liver function.

Blood system: agranulocytosis, thrombocytopenia, anemia (including megaloblastic anemia).

Cardiovascular system: decreased arterial pressure, bradycardia.

Immune system: hypersensitivity reactions, including skin rashes, urticaria, facial swelling, dyspnea, angioneurotic edema, Lyell’s syndrome.

With prolonged use – drug dependence, folate deficiency, impotence, withdrawal syndrome, which usually occurs after abrupt discontinuation of the drug and is accompanied by nightmares and nervousness.

Increased body temperature, lymphadenopathy, leukocytosis, lymphocytosis, leukopenia, increased skin photosensitivity (photosensitization), polymorphic exudative erythema, exfoliative dermatitis, Stevens–Johnson syndrome, collapse.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 2 years from the date of manufacture of the drug in "in bulk" packaging.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 20 mL of the drug in a bottle sealed with a dropper stopper and closed with a cap, in a box.

Supply category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorov'ya".

(Packaging from "in bulk" drug produced by Kharkiv Pharmaceutical Enterprise "Zdorov'ya Narodu" LLC, Ukraine).

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, Kharkiv, Shevchenko Street, 22.