Corvalol-Extra (Drops) Instructions for Use

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

C01EX (Other combined drugs for the treatment of heart diseases)

Dosage Form

Corvalol-Extra

Oral drops: 15 or 25 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent colorless or slightly colored liquid with a specific odor.

Excipients: sodium acetate trihydrate – 1 mg, ethanol (ethyl alcohol) 95% – 0.73 ml, purified water – up to 1 ml.

15 ml – dropper bottle – cardboard packs.
15 ml – bottles – cardboard packs.
25 ml – dropper bottle – cardboard packs.
25 ml – bottles – cardboard packs.

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Reflex-acting coronary dilator

Pharmacological Action

A combined drug whose action is determined by the properties of its constituent substances.

It has a sedative and antispasmodic action. It facilitates the onset of natural sleep.

Ethyl ester of α-bromoisovaleric acid has a sedative (similar to the effect of valerian) and antispasmodic action.

Phenobarbital enhances the sedative effect of other components, helps reduce excitation of the central nervous system and facilitates the onset of sleep.

In addition to the main components listed above (highlighted in italics), some preparations contain peppermint oil in their composition, which has a reflex vasodilating and antispasmodic action.

In addition to the main components listed above (highlighted in italics), some preparations contain Levomenthol solution in menthyl isovalerate – a reflex-acting coronary dilator that causes a sedative effect. The reflex vasodilating action is due to the irritation of sensitive nerve endings. It stimulates the production and release of enkephalins, endorphins and a number of other peptides, histamine, kinins (due to irritation of the receptors of the mucous membrane), which are actively involved in the regulation of vascular permeability and the formation of pain sensations.

Indications

As a sedative and vasodilator for the following diseases: functional disorders of the cardiovascular system (cardialgia, sinus tachycardia, increased blood pressure); insomnia (difficulty falling asleep); neurotic states; autonomic lability; irritability; hypochondriacal syndrome.

As an antispasmodic agent: spasm of the gastrointestinal tract musculature (intestinal and biliary colic).

ICD codes

Dosage Regimen

Administer the drug orally, before meals.

Dissolve 15 to 30 drops in a small amount (30-50 ml) of water.

Take this dose 2 to 3 times per day.

For conditions such as tachycardia, the single dose can be increased to 40-50 drops if necessary.

For pediatric patients, administer 3 to 15 drops per day.

The exact daily dose for a child is determined by the physician based on age and clinical presentation.

The duration of therapy is determined individually by the physician.

Do not exceed the recommended dosage without medical supervision.

Be aware that long-term use carries a risk of drug dependence and chronic bromism.

Exercise caution when driving or operating machinery due to potential drowsiness and dizziness.

Adverse Reactions

Drowsiness, dizziness, decreased ability to concentrate, allergic reactions.

With long-term use – chronic bromine poisoning (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, coordination disorders); drug dependence.

Contraindications

Hypersensitivity; severe hepatic and/or renal failure; lactation period (breastfeeding).

Use in Pregnancy and Lactation

If it is necessary to prescribe Corvalol during lactation, the issue of discontinuing breastfeeding should be decided.

Use with caution during pregnancy.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

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.