Cravaleon (Drops) Instructions for Use

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Crataegi folium cum flore (DAB German Pharmacopoeia)

Valerian (BP British Pharmacopoeia)

Leonuri herba (SP State Pharmacopoeia)

Dosage Form

Cravaleon

Oral drops: 20 ml or 25 ml dropper bottle, 20 ml or 25 ml bottle, or 50 ml bottle.

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

The drug has a sedative, as well as spasmolytic and moderate cardiotonic action.

Indications

• As a sedative in the complex therapy of functional disorders of the cardiovascular system, cardialgia, climacteric syndrome, increased nervous excitability, sleep disorders.

ICD codes

Dosage Regimen

Administer the drug orally.

Take 10-20 drops three to four times daily, 30 minutes before meals.

If clinically necessary, increase the single dose to a maximum of 30 drops.

Dilute the drops in a small amount of water immediately before administration.

The standard treatment course is 20 to 30 days.

Conduct repeated courses only after consultation with a physician.

Do not exceed the recommended daily dosage.

Discontinue use and seek medical advice if adverse reactions occur.

Adverse Reactions

Allergic reactions, drowsiness, and decreased performance are possible. In rare cases, dyspeptic disorders may develop.

Contraindications

• Arterial hypotension;
• Decreased heart rate (less than 55 beats/min);
• Pregnancy;
• Lactation period;
• Age under 18 years;
• Hypersensitivity to the drug components.

With caution in liver diseases, alcoholism, epilepsy, traumatic brain injuries, brain diseases.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

The preparation contains not less than 64% ethyl alcohol. The maximum daily dose of the drug (120 drops = 2.35 ml) contains 1.3 g of ethanol.

Influence on the ability to drive vehicles and operate machinery.

When using the drug, a decrease in concentration and speed of psychomotor reactions is possible, therefore it should not be used when engaging in potentially hazardous activities (driving vehicles, working with machinery, etc.) that require concentration and quick mental and motor reactions. The drug is not intended for the relief of cardialgia attacks.

Overdose

With prolonged use of the drug in doses exceeding the recommended ones, an increase in the severity of such side effects as drowsiness, decreased performance, and dyspeptic disorders is possible.

Drug Interactions

With the simultaneous use of Cravaleon with drugs that depress the central nervous system (sedatives, hypnotics, tranquilizers, neuroleptics), mutual enhancement of effects is possible.

Storage Conditions

Store the drug in a light-protected place at a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 2 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.