Calming herb mixture № 2

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALMNESS HERBAL BLEND № 2 (SPECIES SEDATIVAE № 2)

Composition:

Active ingredients: motherwort herb (Leonuri cardiacae herba); hops strobiles (Lupuli flos); peppermint leaves (Menthae piperitae folium); valerian rhizomes with roots (Valerianae radix); licorice roots (Liquiritiae radix).

1 g of the blend contains: motherwort herb (Leonuri cardiacae herba) 400 mg, hops strobiles (Lupuli flos) 200 mg, peppermint leaves (Menthae piperitae folium) 150 mg, valerian rhizomes with roots (Valerianae radix) 150 mg, licorice roots (Liquiritiae radix) 100 mg.

Pharmaceutical form. Herbal blend.

Main physicochemical properties:

Cut herb: a mixture of heterogeneous particles about 5 mm in size, grayish-green in color with light-yellow, yellow, and grayish-brown inclusions. Aromatic odor. Sweetish-bitter taste.

Coarse powder: a mixture of heterogeneous particles about 2 mm in size, grayish-green in color with light-yellow, yellow, and grayish-brown inclusions. Aromatic odor. Sweetish-bitter taste.

Pharmacotherapeutic group. Sedatives and tranquilizers. ATC code N05CM.

Pharmacological Properties.

Pharmacodynamics.

The biologically active substances of the drug exert a sedative and spasmolytic effect, reducing excitability of the central nervous system.

Clinical characteristics.

Indications.

Insomnia, neurocirculatory dystonia, increased excitability, neurasthenia – as part of complex therapy.

Contraindications.

Hypersensitivity to biologically active substances of the drug. Depression and diseases accompanied by suppression of central nervous system activity; liver and kidney dysfunction; bronchial asthma, hypokalemia, severe degree of obesity.

Special precautions.

Use with caution in patients with gastroesophageal reflux, esophagitis, myocarditis, pericarditis, myocardial infarction, bradycardia.

Interaction with other medicinal products and other types of interactions.

The infusion can be combined with other sedatives and cardiovascular agents. Concurrent use may enhance hypokalemia when administered together with cardiac glycosides, antiarrhythmic drugs (quinidine), thiazide and loop diuretics, laxatives. Enhances the effects of hypnotics, analgesics, antihypertensive drugs, cardiac glycosides, and alcohol.

Special precautions.

Use during pregnancy or breastfeeding. Only upon a physician's prescription, if the benefit to the mother outweighs the potential risk to the fetus/infant. If treatment is necessary, breastfeeding must be discontinued.

Ability to influence reaction rate while driving or operating machinery. Use with caution in individuals who drive or operate machinery.

Method of Administration and Dosage.

Place 2 tablespoons of the herbal mixture into an enameled container, pour 200 ml of boiled water, heat on a water bath for 15 minutes, then allow to steep at room temperature for 45 minutes and strain. Squeeze out the remaining plant material, and adjust the volume of the resulting infusion to the initial 200 ml with boiled water. Adults should take 1/3 cup of the warm infusion, children aged 12 years and older—1/4 cup of the warm infusion, taken 20–30 minutes before meals, twice daily. The treatment course lasts 2–4 weeks.

Place 2 filter bags into a glass or enameled container, pour 200 ml (1 cup) of boiling water, cover and let steep for 15 minutes. Adults should take 1 cup of the warm preparation orally twice daily; children aged 12 years and older should take 1/2 cup, 20–30 minutes before meals. The treatment course lasts 2–4 weeks.

Children.

Do not use the drug in children under 12 years of age.

Overdose.

Overdose or prolonged use (longer than 2 months) may cause disturbances in water-electrolyte balance, feelings of depression, increased fatigue, headache, drowsiness, dizziness, decreased arterial blood pressure, nausea, bradycardia, and increased blood coagulation, requiring discontinuation of the drug. Treatment is symptomatic (gastric lavage, activated charcoal, sodium sulfate).

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis). In hypersensitive individuals, valerian rhizomes with roots may cause sleep disturbances and paradoxical excitatory effects. Abdominal cramps, nausea, intestinal dysfunction, headache, weakness, dizziness, drowsiness, suppression of emotional responses, bradycardia, arrhythmia, decreased mental and physical performance, and hypokalemia may occur.

If any of these or other unusual reactions occur, discontinue use of the product and consult a physician.

Shelf life. 2 years.

Do not use after the expiry date.

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 at 8–15 °C for no more than 2 days.

Packaging.

50 g or 75 g in boxes with inner pouch; 1.5 g in filter bags No. 20 in a box.

Release category. Over-the-counter (without prescription).

Manufacturer. JSC "Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

4 Skladska Street, Zaporizhzhia, Ukraine, 69050.

Marketing Authorization Holder. JSC "Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.