Melissae officinalis herba (Herbal raw material) Instructions for Use

Instructions
Dosage forms

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substance

Melissa (DAB German Pharmacopoeia)

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A herbal preparation. It exerts sedative, anticonvulsant, antihypertensive, antiarrhythmic, spasmolytic, and antiemetic effects. The main active substances are components of the essential oil (0.06-1%), including citral (up to 62%), geraniol, linalool, neral, caryophyllene, which, in combination with terpenoids, glucosides of eugenol, benzyl alcohol, and phenolic acids, provide antimicrobial, antiviral, and anti-inflammatory activity.

The active components of lemon balm improve digestive processes, exert a mild choleretic effect, promote the restoration of the intestinal saprophytic flora and the secretion of digestive enzymes. Along with the essential oil, vitamins B₁, B₂, C and a complex of trace elements, including potassium, have a beneficial effect on the functions of the nervous system. The latter, in combination with geraniol and phenolic acids, provides a negative chronotropic effect, contributing to the normalization of cardiac activity and vascular tone. Due to the complex of biologically active substances, lemon balm preparations exhibit a pronounced antihypoxic effect, which in turn underlies their cardio-, neuro-, nephro-, and immunoprotective properties. They eliminate mild forms of dysmenorrhea, manifestations of pregnancy toxemia, climacteric disorders, and normalize the function of the gonads in men.

Components of the essential oil, flavonoids, terpenoids, chlorogenic, rosmarinic, ferulic, salicylic acids improve the drainage function of the ciliated epithelium of the respiratory tract, reduce sputum viscosity, facilitate its expectoration with cough, and exert an antipyretic effect by enhancing heat transfer (dilation of skin vessels, increased sweating). When applied to the skin and mucous membranes, lemon balm preparations exhibit analgesic, anti-inflammatory, antipruritic, antimicrobial, and antiviral effects.

Indications

Neuroses, neurocirculatory dystonia of the hypertensive type, mild form of arterial hypertension, mild forms of coronary artery disease, tachyarrhythmias; acute and chronic gastrointestinal diseases, dyskinesias, dysbiosis, enzymopathies, flatulence; acute and chronic inflammatory diseases of the respiratory organs (of bacterial and viral origin); dermatitis accompanied by itching, eczema, trophic ulcers; menstrual cycle disorders, climacteric disorders, pregnancy toxemias; immunodeficiency states (as part of combination therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
D84.9	Immunodeficiency, unspecified
F45.3	Somatoform dysfunction of the autonomic nervous system
F48.0	Neurasthenia
F48.9	Unspecified neurotic disorder
I10	Essential [primary] hypertension
I20	Angina pectoris
J00	Acute nasopharyngitis (common cold)
J01	Acute sinusitis
J02	Acute pharyngitis
J03	Acute tonsillitis
J04	Acute laryngitis and tracheitis
J06.9	Acute upper respiratory infection, unspecified
J15	Bacterial pneumonia, not elsewhere classified
J20	Acute bronchitis
J31.0	Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J31.2	Chronic pharyngitis
J32	Chronic sinusitis
J35.0	Chronic tonsillitis
J37	Chronic laryngitis and laryngotracheitis
J42	Unspecified chronic bronchitis
K29	Gastritis and duodenitis
K52.9	Noninfective gastroenteritis and colitis, unspecified
K63.8	Other specified diseases of intestine
K82.8	Other specified diseases of gallbladder and cystic duct (including dyskinesia)
L20.8	Other atopic dermatitis (neurodermatitis, eczema)
L23	Allergic contact dermatitis
L28.0	Lichen simplex chronicus (circumscribed neurodermatitis)
L29	Pruritus
L30.0	Nummular eczema
L98.4	Chronic skin ulcer, not elsewhere classified
N92.6	Irregular menstruation, unspecified
N95.1	Menopausal and other perimenopausal disorders
N95.3	States associated with artificial menopause
O10-O16	Edema, proteinuria and hypertensive disorders during pregnancy, childbirth and the puerperium
R00.0	Tachycardia, unspecified (including nodal (sinus) NOS)
R14	Flatulence and related conditions (including abdominal bloating, belching)

ICD-11 code	Indication
4A0Z	Unspecified primary immunodeficiencies
6A8Z	Affective disorders, unspecified
6B6Z	Dissociative disorders, unspecified
6C20.Z	Bodily distress disorder, unspecified
9A06.70	Atopic eczema of the eyelids
BA00.Z	Essential hypertension, unspecified
BA40.Z	Angina pectoris, unspecified
CA00	Acute nasopharyngitis
CA01	Acute rhinosinusitis
CA02.Z	Acute pharyngitis, unspecified
CA03.Z	Acute tonsillitis, unspecified
CA05	Acute laryngitis or tracheitis
CA07.0	Acute upper respiratory tract infection of unspecified site
CA09.0	Chronic rhinitis
CA09.2	Chronic pharyngitis
CA0A.Z	Chronic rhinosinusitis, unspecified
CA0F.Y	Other specified chronic diseases of the palatine tonsils and adenoids
CA0G	Chronic laryngitis or laryngotracheitis
CA20.1Z	Chronic bronchitis, unspecified
CA40.0Z	Bacterial pneumonia, unspecified
CA42.Z	Acute bronchitis, unspecified
DA42.Z	Gastritis, unspecified
DA51.Z	Duodenitis, unspecified
DA7Z	Diseases of stomach or duodenum, unspecified
DA90.0	Syndromic diarrhea
DA92.1	Pneumatosis intestinalis of the small intestine
DA98.Z	Polyps of small intestine, unspecified
DB31.1	Pneumatosis of the colon
DB36.Z	Certain infections of the colon, unspecified
DC1Z	Diseases of gallbladder and biliary tract, unspecified
DD94	Functional disorder of the gallbladder
DE2Z	Diseases of the digestive system, unspecified
EA40	Tropical phagedenic ulcer
EA80.0	Infantile atopic eczema
EA80.1	Childhood atopic eczema
EA80.2	Adult atopic eczema
EA80.Z	Atopic eczema, unspecified
EA82	Nummular dermatitis
EA83.00	Lichen simplex of vulva
EA83.01	Lichen simplex of male genital organs
EA83.02	Lichen simplex of perianal area
EA83.0Z	Lichen simplex of unspecified location
EA85.20	Atopic hand eczema
EC90.Z	Itching, unspecified
EF60	Ischemic ulceration of the skin
EK00.Z	Allergic contact dermatitis, unspecified
EM0Z	Unspecified skin disorder
GA20.3	Irregular uterine bleeding
GA30.00	Menopausal or climacteric states in women
GA30.3	States associated with artificial menopause
JA2Z	Edema, proteinuria, or hypertensive disorders in pregnancy, childbirth or the puerperium, unspecified
MC81.Z	Abnormalities of heart rhythm, unspecified
ME08	Flatulence and related conditions
ME60.2	Ulcerative skin lesion of unspecified nature

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.

Herbal raw material

About 2-3 g (1 tablespoon) of the crushed herb is placed in a glass or enamel bowl, poured with 200 ml (1 cup) of boiling water, covered with a lid, and heated in a boiling water bath for 15 minutes. Then it is cooled at room temperature for 45 minutes, strained, and the remaining raw material is squeezed out. The volume of the resulting infusion is adjusted to 200 ml with boiled water.

The infusion is prescribed orally in a warm form, 1/2-1/3 cup 2-3 times/day, 1 hour after meals. The treatment course is 3-4 weeks.

Adverse Reactions

In some cases hypersensitivity reactions to lemon balm.

Contraindications

Hypersensitivity to lemon balm; drowsiness, lethargy, retardation.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the lemon balm drug leaflets regarding contraindications for the use of specific lemon balm dosage forms in children of different ages.

Special Precautions

Lemon balm potentiates the action of hypotensive, analgesic, and central nervous system depressant drugs.

Drug Interactions

It enhances the effect of hypnotics and other drugs that depress the central nervous system.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Melissae officinalis herba [Azulen-Temryuk LLC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Azulen-Temryuk LLC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Apex, LLC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Apex, LLC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Jindal, LLC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Jindal, LLC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Ivan-Chai JSC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Ivan-Chai JSC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Ivan-Chai JSC (Russia)]
Herbal raw material crushed 50 g: packs

Marketing Authorization Holder

Ivan-Chai JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material crushed 50 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	50 g

50 g – paper bags (1) – cardboard packs.

Melissae officinalis herba [Ivan-Chai JSC (Russia)]
Herb powder 1.5 g: filter bags 20 pcs.

Marketing Authorization Holder

Ivan-Chai JSC (Russia)

Dosage Form

Melissae officinalis herba

Herb powder 1.5 g: filter bags 20 pcs.

Dosage Form, Packaging, and Composition

Herb powder in the form of pieces of stems, leaves, flowers, and buds passing through a sieve with 2 mm holes; color from grayish-green to green; odor weak; taste of the aqueous extract slightly bitter.

	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (20) – cardboard packs.

Melissae officinalis herba [Krasnogorskleksredstva, JSC (Russia)]
Herbal raw material-powder 1.5 g: filter-bags 20 pcs.

Marketing Authorization Holder

Krasnogorskleksredstva, JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material-powder 1.5 g: filter-bags 20 pcs.

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (20) – cardboard packs.

Melissae officinalis herba [Lek S+, LLC (Russia)]
Herbal raw material-powder 1.5 g: filter-bags 20 pcs.
Herbal raw material, crushed: 30 g, 50 g, 75 g packs

Marketing Authorization Holder

Lek S+, LLC (Russia)

Dosage Forms

	Melissae officinalis herba	Herbal raw material-powder 1.5 g: filter-bags 20 pcs.
		Herbal raw material, crushed: 30 g, 50 g, 75 g packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	100 %

30 g – Paper bags (1) – cardboard packs.
50 g – Paper bags (1) – cardboard packs.
75 g – Paper bags (1) – cardboard packs.

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (20) – cardboard packs.

Melissae officinalis herba [Narodnaya Meditsina Medical Company, LLC (Russia)]
Herbal raw material crushed 50 g: packs

Marketing Authorization Holder

Narodnaya Meditsina Medical Company, LLC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material crushed 50 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	50 g

50 g – paper bags (1) – cardboard packs.

Melissae officinalis herba [Pyatigorsk Pharmaceutical Factory LLC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Pyatigorsk Pharmaceutical Factory LLC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [St.-Medifarm, JSC (Russia)]
Herbal raw material - powder 1.5 g: filter-bags 10, 20, 24, or 30 pcs.

Marketing Authorization Holder

St.-Medifarm, JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material – powder 1.5 g: filter-bags 10, 20, 24, or 30 pcs.

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (10) – cardboard packs.
1.5 g – filter bags (20) – cardboard packs.
1.5 g – filter bags (24) – cardboard packs.
1.5 g – filter bags (30) – cardboard packs.

Melissae officinalis herba [St.-Medifarm, JSC (Russia)]
Herbal raw material crushed 50 g: packs

Marketing Authorization Holder

St.-Medifarm, JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material crushed 50 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	50 g

50 g – paper bags (1) – cardboard packs.

Melissae officinalis herba [St.-Medifarm, JSC (Russia)]
Herbal raw material, crushed 25 g: packs

Marketing Authorization Holder

St.-Medifarm, JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material, crushed 25 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	25 g

25 g – Paper bags (1) – cardboard packs.

Melissae officinalis herba [St.-Medifarm, JSC (Russia)]
Herbal raw material, crushed 30 g: packs

Marketing Authorization Holder

St.-Medifarm, JSC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material, crushed 30 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	30 g

30 g – Paper bags (1) – cardboard packs.

Melissae officinalis herba [St.-Medifarm, JSC (Russia)]
Crushed herbal raw material 100 g: packs

Marketing Authorization Holder

St.-Medifarm, JSC (Russia)

Dosage Form

Melissae officinalis herba

Crushed herbal raw material 100 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	100 g

100 g – Paper bags (1) – cardboard packs.

Melissae officinalis herba [Tekhmedservis CJSC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Tekhmedservis CJSC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Travnik PZK (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Travnik PZK (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Pharos-21, LLC (Russia)]
Herbal raw material - powder 1.5 g: filter bags 10 or 20 pcs.

Marketing Authorization Holder

Pharos-21, LLC (Russia)

Dosage Form

Melissae officinalis herba

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

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

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

Melissae officinalis herba [Firm "Fito-Bot", LLC (Russia)]
Herb powder 1.5 g: filter bags 20 pcs.

Marketing Authorization Holder

Firm "Fito-Bot", LLC (Russia)

Dosage Form

Melissae officinalis herba

Herb powder 1.5 g: filter bags 20 pcs.

Dosage Form, Packaging, and Composition

Herb powder in the form of pieces of stems, leaves, flowers, and buds passing through a sieve with 2 mm openings; when examined under a magnifying glass or stereomicroscope, pieces of leaves of green, grayish-green, or greenish-brown color are visible; petioles, stems of grayish-green or light green color, rarely – a grayish-green or brownish calyx and a yellowish-white corolla; pieces of stems are partially split in the longitudinal section and have a yellowish-white spongy pith; on fragments of leaf blades, numerous dark brown shiny rounded formations (essential oil glands) and whitish hairs are noticeable, especially numerous on pieces of young leaves; the odor is weak, aromatic; the taste of the aqueous extract is slightly bitter.

	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (20) – cardboard packs.

Melissae officinalis herba [Health Firm, LLC (Russia)]
Herbal raw material-powder 1.5 g: filter-bags 20 pcs.

Marketing Authorization Holder

Health Firm, LLC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material-powder 1.5 g: filter-bags 20 pcs.

Dosage Form, Packaging, and Composition

Herbal raw material – powder	1 filter bag
Melissa officinalis herb	1.5 g

1.5 g – filter bags (20) – cardboard packs.

Melissae officinalis herba [Health Firm, LLC (Russia)]
Herbal raw material crushed 50 g: packs

Marketing Authorization Holder

Health Firm, LLC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material crushed 50 g: packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed	1 pack
Melissa officinalis herb	50 g

50 g – paper bags (1) – cardboard packs.

Melissae officinalis herba [Fito-Bot, LLC (Russia)]
Herbal raw material, crushed: 50 g packs

Marketing Authorization Holder

Fito-Bot, LLC (Russia)

Dosage Form

Melissae officinalis herba

Herbal raw material, crushed: 50 g packs

Dosage Form, Packaging, and Composition

Herbal raw material crushed : pieces of stems, leaves, flowers, and buds of various shapes, passing through a sieve with 7 mm openings; color from green to greenish-brown, with grayish-green, light green, light brown, brown, brownish-white, yellowish-white inclusions; the odor is weak, aromatic; the taste of the aqueous extract is slightly bitter.