Valemidin^® (Drops) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Sedative

Pharmacological Action

It exerts a sedative and spasmolytic action.

Indications

Employ for the management of specific neurotic conditions and autonomic nervous system disorders.

• Neuroses, including conditions presenting with anxiety and emotional lability.
• Neurocirculatory dystonia specifically of the hypertensive type, characterized by labile blood pressure and autonomic symptoms.

ICD codes

Dosage Regimen

Administer orally after diluting the drops in a small quantity of water, ensuring intake occurs 30 minutes before meals to optimize absorption.

For adult patients, prescribe a dosage of 30-40 drops, to be taken 3-4 times daily.

The standard treatment course spans 10-15 days. Do not initiate repeated courses without medical consultation; maintain an interval of at least 1-1.5 months between treatment cycles as recommended by a physician.

Adverse Reactions

From the digestive system, dyspepsia occurs rarely; prolonged therapy may lead to dry mouth.

Allergic reactions, including skin rash and pruritus, are possible. Monitor for any worsening of listed effects or the emergence of unlisted adverse events and report them to a healthcare professional immediately.

Contraindications

Do not administer under any circumstances to patients with specific severe conditions or hypersensitivities.

• Severe impairment of liver or renal function.
• Established arterial hypotension or significant bradycardia (heart rate less than 55 beats per minute).
• Presence of acute or chronic heart failure.
• Patients under the age of 18 years due to unestablished efficacy and safety profile.
• Known hypersensitivity to any component of the formulation.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated: severe liver function impairment.

Use in Renal Impairment

Contraindicated: severe renal impairment.

Pediatric Use

Contraindicated: children under 18 years of age (efficacy and safety have not been established).

Special Precautions

The content of absolute ethyl alcohol in the maximum single dose for adults (40 drops) is 0.58 g, in the maximum daily dose for adults (160 drops) – 2.3 g.

Influence on the ability to drive vehicles and mechanisms

It contains Diphenhydramine and ethanol, therefore, during the period of use, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Exercise extreme caution with concomitant use of other central nervous system depressants, including sedatives, hypnotics, tranquilizers, and neuroleptics, due to the risk of mutual enhancement of depressive effects.

Avoid concurrent use with monoamine oxidase inhibitors (MAOIs) and other drugs metabolized by liver enzymes without medical supervision.

Overdose

Symptoms of overdose are primarily an extension of the drug’s pharmacological effects and may manifest as pronounced sedation, drowsiness, or confusion.

In severe cases, expect significant depression of the central nervous system, potentially leading to stupor. There is no specific antidote; management involves gastric lavage, administration of activated charcoal, and provision of supportive and symptomatic care.

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.