MELISSA HERB

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MELISSA HERB (MELISSAE HERBA)

Composition:

Active substance: Melissa herb (Melissae herba);

1 pack contains 50 g of Melissa herb (Melissae herba); 1 tea bag contains 1.5 g of Melissa herb (Melissae herba).

Pharmaceutical form. Herb.

Main physicochemical characteristics:

Cut material: fragments of stems, leaves with pieces of flowers, or individual flowers, with or without them, passing through a sieve with 5.6 mm openings. Color of stems is green; leaves range from light green or grayish-green to dark green; corollas are yellowish, white, or pale lilac. Odor is pleasant, lemon-like. Taste is bitter-spicy.

Coarse powder: a mixture of fragments of stems, leaves, and flowers ranging from light or grayish-green to green in color, with yellowish, white, or pale lilac specks, passing through a sieve with 1.4 mm openings. Odor is pleasant, lemon-like. Taste is bitter-spicy.

Pharmacotherapeutic group. Sedative and hypnotic agent. ATC code N05CM.

Clinical characteristics.

Indications.

Conditions of general nervous excitement (increased emotional activity, excitability, irritability), insomnia, neurocirculatory dystonia, changes in arterial pressure due to stress.

Contraindications.

Hypersensitivity to the drug, arterial hypotension.

Interaction with other medicinal products and other forms of interaction.

Concomitant use may enhance the effect of other sedative and hypnotic agents.

Special precautions for use.

Consult your doctor before starting treatment.

Use during pregnancy or breastfeeding.

There is no information available regarding the experience of using the drug during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Use with caution in individuals who drive or operate mechanical devices.

Dosage and Administration.

Place 1 tablespoon of the herb into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and let stand on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze the residue into the strained infusion. Adjust the volume of the infusion with boiled water to 200 mL. Adults should take warm, ⅓ cup 3 times daily, 15–20 minutes before meals. Children aged 3–5 years – 1 teaspoon, 5–7 years – 1 dessert spoon, 7–12 years – 1 tablespoon, 12–14 years – 2 tablespoons, and those aged 14 years and older – ¼ cup, 3 times daily, 15–20 minutes before meals. Before use, the infusion should be shaken.

Place 2 filter packets into a glass or enameled container, pour 200 mL of boiling water, cover and let steep for 15 minutes. Adults should take warm, ½ cup 3–4 times daily, 15–20 minutes before meals. Children aged 3–5 years – 1 dessert spoon, 5–7 years – 1 tablespoon, 7–12 years – 2 tablespoons, 12–14 years – ¼ cup, and those aged 14 years and older – ⅓ cup, 3 times daily, 15–20 minutes before meals.

The duration of treatment is determined by a physician.

Children. Do not use in children under 3 years of age.

Overdose.

In case of overdose, dizziness, lethargy, and decreased concentration may occur.

Treatment. Discontinue use of the product and consult a physician.

Side effects.

Allergic reactions are possible, including hyperemia, rash, itching, and skin swelling. If side effects occur, discontinue use of the drug and consult a physician.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children. Prepared infusion should be stored in a cool place (8–15 °C) for no more than 2 days.

Packaging. 50 g in cartons with an inner packet; 1.5 g in tea-filter bags; 20 filter bags per carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69050, Ukraine, Zaporizhzhia, Skladska St., 4.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder. 69063, Ukraine, Zaporizhzhia, Amosova Akademika St., 75.