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Corvalol (Tablets, Drops) Instructions for Use

ATC Code

N05CB02 (Barbiturates in combination with other drugs)

Active Substances

Phenobarbital (Rec.INN registered by WHO)

Ethylbromisovalerinate (Grouping name)

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.

Phenobarbital has a vasodilating, hypnotic (in appropriate doses) and mild hypotensive effect, and enhances the sedative effect of other components.

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

Peppermint oil, included in some combined drugs as an auxiliary component, has a reflex vasodilating and antispasmodic action. Some drugs contain hop cone oil or oregano oil as auxiliary components.

Indications

As a sedative and vasodilator for insomnia (difficulty falling asleep); cardialgia; sinus tachycardia; neurotic states; autonomic lability; irritability; hypochondriacal syndrome; arterial hypertension (early stages).

As an antispasmodic for spasms 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
I10 Essential [primary] hypertension
I49.8 Other specified cardiac arrhythmias
K80 Cholelithiasis [cholelithiasis] (including biliary colic)
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
BA00.Z Essential hypertension, unspecified
BC62 Accessory pathway
BC65.0 Long QT syndrome
BC65.1 Brugada syndrome
BC65.2 Short QT syndrome
BC65.3 Early repolarization syndrome
BC65.4 Idiopathic ventricular fibrillation
BC65.Z Cardiac arrhythmia associated with genetic anomalies, unspecified
BC71.Z Ventricular tachyarrhythmia, unspecified
BC81.6 Inappropriate sinus tachycardia
BC81.Z Supraventricular tachyarrhythmia, unspecified
BC8Z Supraventricular arrhythmia, unspecified
BC90 Atrioventricular nodal rhythm
BE2Y Other specified diseases of the circulatory system
DC11.Z Cholelithiasis, unspecified
DD93.1 Infantile colic
MB24.C Irritability
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.

Drops

Take orally, before meals, after dissolving in a small amount (30-50 ml) of water.

Adults – 15-30 drops 2-3 times/day. A single dose, if necessary (for example, with tachycardia), can be increased to 40-50 drops.

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

The duration of use is determined by the doctor individually.

Tablets

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

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

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

Adverse Reactions

Possible drowsiness, dizziness, decreased ability to concentrate, allergic reactions.

With prolonged use development of chronic bromine poisoning (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements); drug dependence.

Contraindications

Severe hepatic and/or renal impairment; lactation period; hypersensitivity to the components of the drug.

With caution pregnancy.

Use in Pregnancy and Lactation

Should be used with caution during pregnancy.

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

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age

Special Precautions

Effect on the ability to drive vehicles and mechanisms

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.

Drug Interactions

Sedatives – enhancement of the effect.

Methotrexate – possible increase in methotrexate toxicity.

Neuroleptics and anxiolytics – possible enhancement of the drug’s action.

CNS stimulants – weakening of the action of each of the drug’s components.

Ethanol – enhancement of the drug’s effects and increase in its toxicity.

Antibiotics, sulfonamides – reduction of antibacterial activity due to the presence of phenobarbital in the drug composition.

Griseofulvin – decrease in the degree of absorption and, as a result, weakening of the antifungal action (due to the presence of phenobarbital in the drug composition).

Indirect anticoagulants, corticosteroids, doxycycline, estrogens and other drugs metabolized in the liver via oxidation – reduction in effectiveness, because Phenobarbital accelerates their destruction.

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

Altayvitamins, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml, 25 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients : ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Apteka Farmikon, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 or 25 ml dropper bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent colorless liquid with a specific aromatic odor.

1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients : sodium hydroxide 3.15 g, peppermint oil 1.42 g, ethanol 95% 580 ml, purified water 420 ml.

25 ml – orange glass dropper bottles (1) – cardboard packs.
50 ml – orange glass dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Aromasintez, LLC (Russia)

Manufactured By

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

Dosage Form

Bottle OTC Icon Corvalol Tablets: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel; the presence of light gray inclusions is allowed.

1 tab.
Ethylbromisovalerinate 8.2 mg
Phenobarbital 7.5 mg
Peppermint oil 0.58 mg

Excipients : cyclodextrin – 55.55 mg, lactose monohydrate – 43.77 mg, potato starch – 13 mg, microcrystalline cellulose type 101 – 10.5 mg, magnesium stearate – 0.9 mg.

10 pcs. – contour cell packs – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Tablets 0.58 mg+7.5 mg+8.2 mg: from 10 to 300 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical with a bevel, almost odorless or with a faint characteristic odor; the surface of the tablets is white or white with a yellowish tint with inclusions of a darker shade.

1 tab.
Peppermint leaf oil 0.58 mg
Phenobarbital 7.5 mg
Ethylbromisovalerinate 8.2 mg

Excipients : betadex (beta-cyclodextrin) – 55.55 mg, lactose monohydrate (milk sugar) – 26.17 mg, microcrystalline cellulose, corn starch – 13.1 mg, magnesium stearate – 0.9 mg.

10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
20 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
30 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.

Marketing Authorization Holder

Bopharm, PJSC (Russia)

Manufactured By

Pharma Start, LLC (Ukraine)

Dosage Form

Bottle OTC Icon Corvalol Tablets: 20, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat, beveled to the edge, white or almost white, with inclusions.

1 tab.
Peppermint oil 580 mcg
Phenobarbital 7.5 mg
Ethyl ester of α-bromoisovaleric acid 8.2 mg

Excipients : beta-cyclodextrin 55.55 mg, potato starch 13 mg, lactose monohydrate 43.77 mg, microcrystalline cellulose 10.5 mg, magnesium stearate 0.9 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 25 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients : ethanol 95%, sodium hydroxide, peppermint oil, purified water.

25 ml – dropper bottles.

Marketing Authorization Holder

Genel RD, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 25 ml dropper bottle.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients : ethanol 95%, sodium hydroxide, peppermint oil, purified water.

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

Marketing Authorization Holder

Genel RD, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 25 ml dropper bottle.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients : ethanol 95%, sodium hydroxide, peppermint oil, purified water.

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

Marketing Authorization Holder

Kirov Pharmaceutical Factory, SUE (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml, 25 ml, 30 ml, or 50 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg
Peppermint leaf oil 1.42 mg

Excipients: ethanol 95%, sodium hydroxide, purified water.

15 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass dropper bottle (1) – cardboard packs.
30 ml – dark glass dropper bottle (1) – cardboard packs.
50 ml – dark glass dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 25 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

25 ml – dropper bottle.

Marketing Authorization Holder

Murom Instrument-Making Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml or 25 ml

Dosage Form, Packaging, and Composition

Oral drops transparent, colorless, with a specific aromatic odor.

1 ml
Ethylbromisovalerinate 20 mg
Phenobarbital 18.26 mg
Peppermint leaf oil 1.42 mg

Excipients: sodium hydroxide – 3.15 g, ethanol 95% – 580 ml, purified water – 420 ml.

15 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Institute Of Medicine And Standardization, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml, 25 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle (1) – cardboard packs.
25 ml – dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Permpharmacy, PJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle.
25 ml – dropper bottle.

Marketing Authorization Holder

Rostov Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle.
25 ml – dropper bottle.

Marketing Authorization Holder

Sesana, CJS (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottles 15, 25, or 50 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle (1) – cardboard packs.
25 ml – dropper bottle (1) – cardboard packs.
50 ml – dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle.
25 ml – dropper bottle.

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle.
25 ml – dropper bottle.

Marketing Authorization Holder

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

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 25 or 50 ml dropper bottle

Dosage Form, Packaging, and Composition

Oral drops 100 ml
Ethyl ester of α-bromoisovaleric acid 2 g
Phenobarbital 1.826 g
Peppermint oil 0.142 g

Excipients: ethanol 95% – 58 ml, sodium hydroxide – 0.315 g, purified water – up to 100 ml.

25 ml – dark glass dropper bottle (1) – cardboard packs.
50 ml – dark glass dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Farmak, JSC (Ukraine)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg
Peppermint oil 1.42 mg

Excipients: ethanol 95%, sodium hydroxide, purified water.

15 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml or 25 ml

Dosage Form, Packaging, and Composition

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

1 ml
Ethylbromisovalerinate 20 mg
Phenobarbital 18.26 mg
Peppermint leaf oil 1.42 mg

Excipients: ethyl alcohol (ethanol) 95% – 0.79 ml, sodium hydroxide – 0.22 mg, purified water – up to 1 ml.

15 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Tablets: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with inclusions, with a bevel and a score.

1 tab.
Peppermint oil 580 mcg
Phenobarbital 7.5 mg
Ethyl ester of α-bromoisovaleric acid 8.2 mg

Excipients: betadex (beta-cyclodextrin) – 55.55 mg, potato starch – 37.57 mg, lactose monohydrate (milk sugar) – 83.7 mg, magnesium aluminometasilicate (neusilin UFL 2) – 4 mg, talc – 2 mg, magnesium stearate – 0.9 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml bottle

Dosage Form, Packaging, and Composition

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

100 ml
Ethylbromisovalerinate 2 g
Phenobarbital 1.826 g
Peppermint oil 0.142 g

Excipients: sodium hydroxide – 0.315 g, ethanol 95% – 58 ml, purified water – up to 100 ml.

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

Marketing Authorization Holder

Ecolab, CJS (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: 15 ml or 25 ml dropper bottles.

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg

Excipients: ethanol 95%, sodium hydroxide, peppermint oil, purified water.

15 ml – dropper bottle (1) – cardboard packs.
25 ml – dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Tablets: 10, 20, 30, 40, 50, 60, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, with inclusions, round in shape, flat-cylindrical, beveled to the edge with chamfers.

1 tab.
Peppermint leaf oil 0.58 mg
Phenobarbital 7.5 mg
Ethylbromisovalerinate 8.2 mg

Excipients: β-cyclodextrin, corn starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Corvalol Oral drops: dropper bottle 15 ml or 25 ml

Dosage Form, Packaging, and Composition

Oral drops 1 ml
Ethyl ester of α-bromoisovaleric acid 20 mg
Phenobarbital 18.26 mg
Peppermint leaf oil 1.42 mg

15 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass dropper bottle (1) – cardboard packs.

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