Corvalol plusForte (Drops) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Peppermint oil (BP British Pharmacopoeia)

Phenobarbital (Rec.INN WHO registered)

Leonuri herba (SP State Pharmacopoeia)

Dosage Form

Corvalol plusForte

Oral drops: dropper bottle 15 ml or 25 ml

Dosage Form, Packaging, and Composition

Oral drops in the form of a clear greenish-brown liquid, with a characteristic odor; the presence of a suspension of fine particles and the formation of a precipitate during storage is allowed.

Excipients: ethanol (ethyl alcohol 95%) – 83.127 mg, sodium hydroxide – 0.191 mg, purified water – up to 1 ml.

15 ml – dropper bottles made of orange glass (1) – cardboard packs.
25 ml – dropper bottles made of orange glass (1) – cardboard packs.

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined medicinal product. It has a sedative and spasmolytic effect, a moderate cardiotonic effect (slows the rhythm and increases the strength of heart contractions), and has moderate hypotensive properties.

Phenobarbital has a sedative (in small doses), hypnotic, muscle relaxant, and spasmolytic effect, helps reduce excitation of the central nervous system and facilitates the onset of sleep, and enhances the sedative effect of other components.

Motherwort herb has a pronounced sedative (calming), moderate cardiotonic (slows the rhythm and increases the strength of heart contractions) effect, and a moderate hypotensive effect.

Peppermint oil has a reflex vasodilating, spasmolytic, 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 tract mucosa, increasing intestinal peristalsis.

Pharmacokinetics

Data on the pharmacokinetics of motherwort and peppermint components are not available.

Phenobarbital

When taken orally, Phenobarbital is absorbed slowly and completely. C_max in blood plasma is determined after 1-2 hours. Plasma protein binding is 50%, in newborns – 30-40%. It accumulates in the body. It is excreted in breast milk and crosses the placental barrier. It is metabolized in the liver, induces liver microsomal enzymes by isoenzymes CYP3A4, CYP3A5, CYP3A7 (the rate of enzymatic reactions increases by 10-12 times). T_1/2 is 2-4 days. It is excreted by the kidneys in the form of a glucuronide, about 25% – unchanged.

Indications

As a symptomatic (calming) agent for neurosis-like conditions accompanied by increased irritability, sleep onset disorders, tachycardia, states of excitation with pronounced vegetative manifestations; as a symptomatic (calming and vasodilating) agent for functional disorders of the cardiovascular system; and also as an antispasmodic agent – for intestinal spasms.

ICD codes

Dosage Regimen

Administer orally, diluted in a small amount (30-50 ml) of water.

For adults, use 15-30 drops per dose.

For tachycardia, a single dose may be increased to 40-50 drops.

Take 2-3 times daily.

For sleep onset disorders, take 30 drops 30 minutes before bedtime.

The maximum single dose is 50 drops.

The maximum daily dose is 150 drops.

The duration of treatment is determined by the physician based on the clinical picture.

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

Use with caution in patients with a history of alcohol dependence due to the ethanol content.

Avoid activities requiring increased concentration, such as driving, during treatment.

Adverse Reactions

From the immune system frequency unknown – allergic reactions.

From the nervous system frequency unknown – drowsiness, weakness, dizziness, decreased ability to concentrate.

From the heart frequency unknown – slowing of the heart rate.

From the digestive system frequency unknown – dyspepsia.

Contraindications

Hypersensitivity to the components of the combination; severe impairment of renal and/or liver function; hepatic porphyria; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; arterial hypotension; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

With caution

Impaired liver and/or kidney function.

The dosage form may contain ethyl alcohol, in which case this combination should be used with caution in alcoholism, as well as in patients at high risk, including those with liver diseases, traumatic brain injuries, and brain diseases.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

The use of the drug is contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

The use of the drug is contraindicated in severe renal insufficiency.

Pediatric Use

Use is possible according to the dosage regimen.

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.

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.