Corvaldin (Drops) Instructions for Use

Marketing Authorization Holder

Farmak, JSC (Ukraine)

ATC Code

N05CB02 (Barbiturates in combination with other drugs)

Dosage Form

Corvaldin

Oral drops: 25 ml dropper bottle.

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined drug, the action of which is determined by the properties of its constituent substances. It has a sedative and antispasmodic effect. It facilitates the onset of natural sleep.

Phenobarbital enhances the sedative effect of other components and has a mild hypotensive effect.

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

Peppermint oil has a reflex vasodilating and antispasmodic effect.

Indications

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

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

ICD codes

Dosage Regimen

Administer the drops orally, before meals.

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

Take this dose 2-3 times per day.

For tachycardia, increase the single dose to 40-50 drops if necessary.

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

Adjust the pediatric dose based on the child’s age and clinical presentation.

Determine the treatment duration individually based on the patient’s response.

Do not exceed the recommended dosage without medical supervision.

Monitor for signs of drowsiness or dizziness, especially at the beginning of therapy.

Discontinue use and consult a physician if adverse reactions occur.

Avoid prolonged use to prevent the risk of drug dependence or chronic bromine poisoning.

Adverse Reactions

From the nervous system drowsiness, dizziness, decreased ability to concentrate.

Other allergic reactions.

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

Contraindications

Severe hepatic and/or renal failure; hypersensitivity to the components of the combination.

With caution

Pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Use with caution during pregnancy and during the lactation period (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 dosing 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.