Convallari-leonuri drops (Drops) Instructions for Use

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

ATC Code

C01EX (Other combined drugs for the treatment of heart diseases)

Active Substances

Herba Convallariae (SP State Pharmacopoeia)

Leonuri herba (SP State Pharmacopoeia)

Dosage Form

Convallari-leonuri drops

Oral drops: bottle 25 ml

Dosage Form, Packaging, and Composition

25 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with cardiotonic and sedative effects

Pharmacotherapeutic Group

Herbal remedy

Pharmacological Action

A combined herbal medicinal product that has a cardiotonic and sedative effect.

Indications

• Use as a sedative in the complex therapy of functional disorders of the cardiovascular system and mild nervous excitability states.

• Employ for symptoms of nervousness, restlessness, and agitation associated with increased nervous excitability.

• Utilize in the management of nonorganic insomnia and sleep disorders to facilitate sleep onset.

• Apply in the early stages of essential hypertension as part of a comprehensive therapeutic regimen for its mild sedative effects.

ICD codes

Dosage Regimen

Administer orally, diluted in a small amount of water. The standard adult dosage is 15-20 drops taken 2-3 times per day.

Adjust the frequency of administration based on therapeutic response and tolerability. The duration of treatment is determined by the physician according to the clinical condition.

Adverse Reactions

Gastrointestinal disturbances, including nausea, vomiting, and diarrhea, may occur. Cardiovascular effects such as arrhythmia and myasthenia have been reported.

Other potential reactions include headache and allergic reactions, such as skin rash or pruritus. Discontinue use if adverse reactions are severe or persistent.

Drug Interactions

Concomitant use with hypnotics, sedatives, anxiolytics, and other central nervous system depressants leads to an enhanced inhibitory effect on the CNS.

The sedative properties may also potentiate the effects of analgesic drugs. Exercise caution and monitor for excessive sedation when co-administering with these agents.

Contraindications

• Hypersensitivity to lily of the valley herb, motherwort herb, or any other component of the preparation.

• Presence of widespread atherosclerosis, cardiosclerosis, endocarditis, or myocarditis due to the cardiotonic effects.

• Use in children under 12 years of age due to a lack of sufficient safety and efficacy data in this population.

• Pregnancy and lactation are absolute contraindications.

Overdose

Symptoms of overdose may include nausea, vomiting, severe diarrhea, and cardiac arrhythmias.

In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive care. Gastric lavage and administration of activated charcoal may be considered.

Use in Pregnancy and Lactation

The use is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Children are prescribed 1-12 drops (depending on age) 2-3 times/day.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

The dosage form contains ethanol.

Influence on the ability to drive vehicles and mechanisms.

With long-term use in high doses, a decrease in the speed of psychomotor reactions is possible, which should be taken into account when driving vehicles, working with mechanisms, etc.

Storage Conditions

Store at 15°C (59°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.