Corvalol NEO (Drops) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Corvalol NEO

Oral drops: 25 ml or 50 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent greenish-brown liquid, with a characteristic odor; the presence of a suspension of fine particles and/or flakes is allowed, which, when shaken, forms a suspension of fine particles.

Excipients: purified water – up to 1 ml.

To obtain 1000 ml of motherwort tincture, 200 g of motherwort herb and a sufficient amount of 70% ethyl alcohol are used.

25 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; other hypnotics and sedatives

Pharmacological Action

A combined agent, the action of which is due to the properties of its constituent components. It has a sedative and antispasmodic effect, a moderate cardiotonic effect (slows the rhythm and increases the strength of heart contractions), and has moderate hypotensive properties.

Ethylbromisovalerinate has a sedative and antispasmodic effect, due to irritation mainly of the receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central parts of the nervous system and an increase in inhibition in the 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 smooth muscles. In terms of the nature of its action, it is close to valerian preparations.

Motherwort herb has a pronounced sedative effect, moderately reduces the heart rate and increases the strength of heart contractions, and exhibits moderate hypotensive properties.

Peppermint oil has a reflex vasodilating, antispasmodic, mild choleretic, and antiseptic effect. The mechanism of action is associated with the ability to irritate the “cold” receptors of the oral mucosa and reflexively dilate mainly the vessels of the heart and brain. It eliminates the phenomena of flatulence by irritating the receptors of the gastrointestinal mucosa, enhancing intestinal peristalsis.

Diphenhydramine is a first-generation histamine H₁-receptor blocker. The effect on the central system is due to the blockade of histamine H₁-receptors and m-cholinergic receptors of the brain. It reduces or prevents histamine-induced spasms of smooth muscles, increased capillary permeability, tissue edema, itching and hyperemia, has antiemetic, sedative effects, and has a hypnotic effect. Antagonism with histamine is more pronounced in relation to local vascular reactions than to systemic ones, i.e., a decrease in blood pressure.

Indications

Increased nervous excitability; as a sedative for sleep disorders not associated with organic disorders of the central nervous system; neurasthenia.

ICD codes

Dosage Regimen

Administer orally, three times per day, before meals.

Measure the dose using the dropper provided with the bottle.

Dilute the required number of drops in a small amount of water immediately before administration.

The standard single dose for adults is 20-30 drops.

Do not exceed the recommended single and daily dosage.

The maximum daily dose must not exceed 150 drops.

The standard treatment course is 10 to 15 days.

Do not use the product for longer than the recommended course without medical supervision.

If symptoms persist after the treatment course, consult a physician for reevaluation.

Adjust the dosage based on individual tolerance and therapeutic effect.

Avoid abrupt discontinuation after prolonged use.

Do not use in children and adolescents under 18 years of age.

Adverse Reactions

From the hematopoietic system: hemolytic anemia, thrombocytopenia, agranulocytosis.

From the immune system: allergic reactions, including rash, urticaria, difficulty breathing, angioedema.

From the skin and subcutaneous tissues: photosensitivity.

From the psyche: confusion, paradoxical excitation (especially susceptible are elderly patients); in some cases – irritability, euphoria.

From the nervous system: drowsiness, weakness, decreased speed of psychomotor reactions, impaired coordination and speed of reaction, feeling of fatigue, dizziness, decreased ability to concentrate, unsteadiness, convulsions, headache, paresthesia, dyskinesia; in some cases insomnia, tremor.

From the sensory organs: blurred vision, ringing in the ears.

From the cardiovascular system: decreased blood pressure, slowing of heart rate, tachycardia, extrasystole.

From the respiratory system: dryness of the nasal mucosa, bronchi (thickening of bronchial secretions).

From the digestive system: dry mouth, dyspepsia, nausea, vomiting, discomfort in the epigastric region, anorexia.

From the musculoskeletal system: muscle twitching.

From the urinary system: difficult urination, urinary retention.

With long-term use of Corvalol NEO in high doses, the development of drug dependence is possible, as well as the accumulation of bromine in the body and the development of bromism, the manifestations of which can be: depressed mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements.

Contraindications

Hypersensitivity to the components of the product, severe impairment of renal and/or liver function, closed-angle glaucoma, prostatic hyperplasia, bladder neck stenosis, bronchial asthma, epilepsy, porphyria, pyloroduodenal stenosis, erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), stenosing gastric and duodenal ulcer; pregnancy, period of breastfeeding, age under 18 years.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during breastfeeding.

Use in Renal Impairment

Should be used with caution in case of renal impairment.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

This product should be used with caution in the following diseases/conditions: liver disease, renal impairment, glaucoma, urinary retention, bronchitis, COPD.

It may enhance the effect of alcohol, so alcohol consumption during treatment should be avoided.

Avoid use in combination with other drugs that have antihistamine action, including topical medications, cough and cold remedies.

Side effects develop more often in elderly patients. The use of the product by elderly patients with confusion should be avoided. Diphenhydramine may worsen existing ringing in the ears.

Avoid UV radiation during treatment.

It is necessary to inform the doctor about the use of the product: the antiemetic effect may complicate the diagnosis of appendicitis and the recognition of symptoms of overdose with other drugs.

Influence on the ability to drive vehicles and mechanisms

Due to the possibility of dizziness, decreased concentration and other side effects associated with taking the product, during treatment, patients should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor and motor reactions.

Drug Interactions

With simultaneous use of the product with ethanol and drugs that depress the activity of the central nervous system (sedatives, hypnotics, neuroleptics, tranquilizers, tricyclic antidepressants), mutual enhancement of effects is possible.

MAO inhibitors increase the severity and duration of the anticholinergic effects of diphenhydramine. It is recommended to stop using the product 14 days before starting the use of MAO inhibitors or start using it 14 days after discontinuation of MAO inhibitors.

Diphenhydramine may enhance the anticholinergic effects of other drugs (atropine, tricyclic antidepressants).

Antagonistic interaction is noted with simultaneous administration with psychostimulants.

Diphenhydramine is an inhibitor of the cytochrome P450 isoenzyme CYP2D6. Interaction with drugs whose primary metabolism is carried out by CYP2D6 is possible.

It enhances the effect of antispasmodic and analgesic agents.

Alcohol enhances the effect of the product and its toxicity.

It reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.