Lotosonic^® (Tablets) Instructions for Use

Marketing Authorization Holder

Dominanta-Service, JSC (Russia)

Manufactured By

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Lotosonic^®

Film-coated tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets of blue color, round, with a characteristic odor; the cross-section shows two layers: a brownish-gray core with numerous inclusions of white and from light yellow to dark brown color and a blue coating.

	1 tab.
Dry extract	80 mg
From a mixture of medicinal plant raw materials
White mulberry leaves, coral tree leaves, longan euphoria fruits
Dry extract of oriental arborvitae seeds	10 mg
Dry extract of wild date palm seeds	10 mg
Dry extract of lotus seeds	35 mg
Dry extract of lotus seed embryos	8 mg
Dioscorea nipponica rhizome powder	100 mg

Excipients: sucrose, lactose monohydrate, pregelatinized rice starch, povidone K 30, microcrystalline cellulose 102, colloidal silicon dioxide (aerosil), magnesium stearate, sodium starch glycolate.

Coating composition: hypromellose 606, hypromellose 615, maltodextrin, talc, titanium dioxide, patent blue V dye, macrogol-400.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal preparation that has a sedative, hypnotic effect, and possesses anxiolytic and anti-stress activity.

Extracts of Chinese date, lotus, longan euphoria, arborvitae, and coral tree have a sedative effect, reduce irritation and tension manifested in mental fatigue and neurasthenia; in insomnia, they help restore normal sleep.

Extracts of dioscorea, mulberry, and longan, along with a sedative effect, also have a vasodilating effect and improve metabolic processes.

Indications

For increased excitability, irritability, mood lability, directly for emotional and physical trauma, for a state of constant mental tension, fatigue (so-called “manager syndrome”), for insomnia (mild forms).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F43	Reaction to severe stress and adjustment disorders
F48.0	Neurasthenia
F51.2	Nonorganic disorders of the sleep-wake schedule
Z73.0	Burn-out
Z73.3	Stress, not elsewhere classified (physical and mental strain)

ICD-11 code	Indication
6A8Z	Affective disorders, unspecified
6B4Z	Disorders specifically associated with stress, unspecified
7B2Z	Sleep-wake cycle disorders, unspecified
QD85	Burn-out
QE01	Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the drug orally. Swallow the tablet whole with a sufficient amount of water.

For the management of increased excitability, irritability, and stress-related conditions, take 1 tablet twice daily.

For the treatment of insomnia, take a single dose of 1 tablet one hour before bedtime.

Adhere strictly to the twice-daily dosing schedule for non-sleep indications to maintain consistent therapeutic blood levels.

The standard treatment course is 30 days. Do not exceed this duration without medical consultation.

A repeat course may be considered only on the recommendation of a physician following assessment of clinical need.

Do not increase the dose or frequency of administration beyond the specified regimen.

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose; in that case, continue with the regular dosing schedule. Do not take a double dose to make up for a forgotten one.

Discontinue use and consult a doctor if no improvement in symptoms is observed after the initial course of treatment.

Adverse Reactions

Allergic reactions are possible.

Contraindications

Pregnancy, breastfeeding period;
Age (under 18 years);
Hypersensitivity to the components of the drug.

With caution in acute pancreatitis.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated for children under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During treatment, one should refrain from activities requiring increased attention and rapid motor and mental reactions (driving vehicles, operating machinery).

Overdose

Symptoms: drowsiness, lethargy, feeling of depression, nausea.

Treatment: gastric lavage, symptomatic therapy.

Drug Interactions

It enhances the effect of drugs that depress the central nervous system (including hypnotics), antihypertensive drugs, and analgesics (requires adjustment of their doses).

Storage Conditions

In a dry place, protected from light, at a temperature of 15-25°C (59-77°F). Keep out of reach of children!

Shelf Life

Shelf life – 3 years.

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.

Medical Disclaimer