Leonuri herba (Herbal raw material) Instructions for Use

Marketing Authorization Holder

Krasnogorskleksredstva, JSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substance

Leonuri herba (SP State Pharmacopoeia)

Dosage Form

Leonuri herba

Herbal raw material – powder 1.5 g: filter bags 10 or 20 pcs.

Dosage Form, Packaging, and Composition

1.5 g – filter bags (10) – carton packs.
1.5 g – filter bags (20) – carton packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

The infusion has a pronounced sedative effect, possesses hypotensive properties, slows the heart rate, and increases the force of heart contractions.

Indications

• Increased nervous excitability
• Sleep disorders (non-organic origin)
• Neurasthenia
• Neurocirculatory dystonia (somatoform autonomic dysfunction)

ICD codes

Dosage Regimen

Prepare an infusion by placing 2 filter bags (3.0 g) into an enamel or glass bowl. Pour 100 ml (1/2 cup) of boiling water over the bags, cover, and infuse for 15 minutes, periodically pressing on the bags with a spoon to maximize extraction.

Squeeze the bags thoroughly after infusion. Bring the total volume of the resulting liquid to 100 ml by adding boiled water. Administer orally, 1/2 cup (100 ml) of the infusion 3 times per day, 1 hour before meals. Shake the infusion well before each administration.

Adverse Reactions

Adverse reactions are generally infrequent and mild. The most commonly reported events are allergic reactions, such as skin rash, itching, or urticaria, which are associated with individual hypersensitivity to the plant material.

In cases of prolonged use or administration of high doses, manifestations of sedation, including drowsiness and reduced alertness, may occur. Discontinue use immediately if any adverse reaction is suspected.

Contraindications

• Pregnancy at any trimester due to the potential for uterine stimulation.
• Children under 12 years of age due to the lack of sufficient safety and efficacy data in this population.
• Confirmed hypersensitivity (allergy) to Leonuri herba, other plants from the Lamiaceae family, or any component of the preparation.
• Severe bradycardia (slow heart rate) as the drug may further slow the heart rate.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy.

Use during lactation is possible in consultation with the attending physician.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Effect on the ability to drive vehicles and operate machinery

With long-term use of the infusion in large doses, a decrease in psychomotor reactions is possible – caution should be exercised when driving vehicles and operating machinery.

Overdose

No specific cases of overdose have been formally reported. Symptoms of intoxication are theoretically expected to be an exaggeration of the known pharmacological effects.

Potential manifestations include pronounced sedation, severe dizziness, profound weakness, and a significant decrease in blood pressure and heart rate. In case of suspected overdose, immediately discontinue the drug, perform gastric lavage if ingestion was recent, and initiate symptomatic and supportive care.

Drug Interactions

Concurrent use with other sedatives, anxiolytics, or hypnotics (including benzodiazepines, barbiturates) leads to pharmacodynamic potentiation, resulting in enhanced central nervous system depression. Exercise extreme caution when co-administering with antihypertensive agents and drugs that slow AV conduction (e.g., beta-blockers, digoxin, calcium channel blockers), as additive effects on blood pressure and heart rate are possible.

The sedative effect may also be intensified by alcohol and other CNS depressants. Avoid concurrent use with MAO inhibitors (MAOIs) due to a theoretical risk of interaction.

Storage Conditions

Store the drug in a dry place, protected from light; the prepared infusion – in a cool place for no more than 2 days.

Keep out of reach of children.

Shelf Life

The shelf life is 3 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.