Valosedatin (Drops) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Valosedatin

Oral drops: dropper bottle 25 ml

Dosage Form, Packaging, and Composition

Oral drops as a transparent light brown liquid, with the odor of valerian.

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

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined medicinal product with sedative and spasmolytic action.

Sodium bromide possesses anticonvulsant activity.

Levomenthol is a local irritant that exerts a reflex coronary vasodilating effect.

Hawthorn tincture has a cardiotonic action.

Valerian tincture has a sedative and spasmolytic action.

Indications

• Use as a symptomatic remedy for managing manifestations of neurocirculatory dystonia.
• Employ for the symptomatic treatment of neurosis-like states.
• Utilize for the symptomatic management of increased nervous excitability.

ICD codes

Dosage Regimen

Administer orally, three times per day, before meals.

Dilute 15 to 20 drops in a small amount of water immediately prior to administration.

Adhere strictly to the prescribed dosage and frequency; do not exceed the recommended daily intake.

Adverse Reactions

Monitor for potential allergic reactions, drowsiness, dizziness, and bradycardia.

Be aware that with prolonged use, adverse effects may include constipation and symptoms of bromism.

Recognize bromism symptoms as rhinitis, cough, conjunctivitis, lethargy, memory impairment, and skin rash; discontinue use and seek medical attention if these occur.

Contraindications

• Do not use in patients with known hypersensitivity to any component of the formulation.
• Avoid use in patients with severe impairment of liver and/or kidney function.
• Contraindicated in patients with alcoholism, significant brain diseases, during pregnancy, and throughout the lactation period.
• This product is contraindicated in children.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation.

Pediatric Use

Contraindication — childhood.

Drug Interactions

Exercise caution with concomitant use of cardiac glycosides due to the potential for enhancement of the effect of cardiac glycosides, attributed to the presence of hawthorn tincture.

Be aware that the sedative effects may be potentiated when used with other central nervous system depressants, including alcohol, barbiturates, and tranquilizers.

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.