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Corvalol (Tablets, Drops) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; other hypnotics and sedatives

Pharmacological Action

A combined drug, the action of which 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 (Validol) – 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 conditions; autonomic lability; irritability; hypochondriacal syndrome.

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

ICD codes

ICD-10 code Indication
F45.2 Hypochondriacal disorder
F45.3 Somatoform dysfunction of the autonomic nervous system
F48.0 Neurasthenia
F48.9 Unspecified neurotic disorder
F51.0 Nonorganic insomnia
K80 Cholelithiasis [cholelithiasis] (including biliary colic)
R00.0 Tachycardia, unspecified (including nodal (sinus) NOS)
R03.0 Elevated blood-pressure reading without diagnosis of hypertension
R07.2 Pain in the heart region
R10.4 Other and unspecified abdominal pain (colic)
R45.4 Irritability and anger
ICD-11 code Indication
6A8Z Affective disorders, unspecified
6B21.0 Dysmorphic disorder with satisfactory or preserved insight
6B21.1 Dysmorphic disorder with reduced or absent insight
6B21.Z Body dysmorphic disorder, unspecified
6B23.Z Hypochondriasis, unspecified
6B6Z Dissociative disorders, unspecified
6C20.Z Bodily distress disorder, unspecified
7A00 Chronic insomnia
7A01 Acute insomnia
7A0Z Insomnia disorders, unspecified
DC11.Z Cholelithiasis, unspecified
DD93.1 Infantile colic
MB24.C Irritability
MC80.0Z Elevated blood pressure without diagnosis of hypertension, unspecified
MC81.Z Abnormalities of heart rhythm, unspecified
MC86 Precordial pain
MD81.4 Other and unspecified abdominal pain

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Drops

Orally, before meals, 15-30 drops, previously dissolved in a small amount (30-50 ml) of water, 2-3 times/day. The single dose, if necessary (for example, with tachycardia), can be increased to 40-50 drops.

For children – 3-15 drops/day (depending on age and the clinical picture of the disease).

The duration of the drug use is determined by the doctor individually.

Adverse Reactions

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

With long-term use – chronic bromine poisoning (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements); 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 failure.

Use in Renal Impairment

Contraindicated in severe renal failure.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

During the treatment period, caution should 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Farmak, JSC (Ukraine)

Dosage Form

Bottle OTC Icon Corvalol Forte Tablets: 10, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex.

1 tab.
Ethyl bromisovalerinate 12.42 mg
Phenobarbital 11.34 mg
Peppermint oil 0.88 mg

Excipients: lactose monohydrate – 285.25 mg, magnesium stearate – 4 mg, betadex (beta-cyclodextrin) – 85.71 mg, acesulfame K – 0.4 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Renewal Oral drops: bottle 25 ml

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent, colorless liquid with a characteristic odor.

100 ml
Ethylbromisovalerinate (ethyl ester of alpha-bromoisovaleric acid) 2000 mg
Phenobarbital 1826 mg
Peppermint leaf essential oil 142 mg

Excipients: ethanol (ethyl alcohol) 95% – 79 ml, sodium hydroxide solution 1M – to pH 8.0-8.5, purified water – up to 100 ml.

25 ml – dark glass bottles (1) with a dropper cap – cardboard packs.

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