Sedative herbal blend № 2 (sedative)

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALMNESS HERBAL MIXTURE №2 (SEDATIVE) (SEDATIVAESPECIES № 2)

Composition:

Active substances: 1 g of the herbal mixture contains:
herb of motherwort (Leonuri herba) 400 mg,
hops strobiles (Lupuli flos) 200 mg,
leaves of peppermint (Menthae piperitae folia) 150 mg,
valerian rhizomes with roots (Valerianae rhizomata cum radicibus) 150 mg,
liquorice roots (Glycyrrhizae radices) 100 mg.

Pharmaceutical form. Herbal mixture.

Main physicochemical characteristics: heterogeneous mixture of grey-green fragments with light-yellow, yellow, light-brown, greyish-brown and brown inclusions.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances of the drug exert sedative and spasmolytic effects, reducing excitability of the central nervous system.

Clinical characteristics.

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

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

Interaction with other medicinal products and other types of interactions. The tincture may be combined with other sedatives and cardiovascular agents. Concurrent use with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, and laxatives may enhance hypokalemia. Enhances the effects of hypnotics, analgesics, antihypertensive agents, cardiac glycosides, and alcohol.

Special precautions for use.

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

Use during pregnancy or breastfeeding. Only under a physician's supervision if the benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery. Use with caution in individuals who drive or operate mechanical equipment.

Method of Administration and Dosage.

Place 2 tablespoons of the herbal mixture into an enameled container, pour 200 ml of hot boiled water, cover with a lid, and steep in a water bath for 15 minutes. Cool at room temperature for 45 minutes, then strain and squeeze the residue, adding the expressed liquid back to the strained infusion. Adjust the final volume of the infusion to 200 ml with boiled water. Administer warm, twice daily, 20–30 minutes before meals:

• Adults and children aged 14 years and older – ⅓ cup,
• Children aged 10–14 years – ¼ cup,
• Children aged 7–10 years – 2 tablespoons,
• Children aged 6–7 years – 1 dessert to 1 tablespoon.
  Shake the infusion well before use.

Alternatively, place 2 filter packets into a glass or enameled container, pour 200 ml of boiling water, cover, and let steep for 15 minutes. Administer warm, twice daily, 20–30 minutes before meals:

• Adults and children aged 14 years and older – 1 cup,
• Children aged 10–14 years – ½ cup,
• Children aged 7–10 years – ⅓ cup,
• Children aged 6–7 years – 2 tablespoons.

Store the prepared infusion at 8–15°C for no more than 2 days.

The treatment course lasts 2–4 weeks.

Children. This medicinal product should be administered to children aged 6 years and older only as prescribed by a physician.

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, which require discontinuation of the product. 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 case of hypersensitivity to valerian rhizomes with roots, sleep disturbances and paradoxical excitatory effects may occur. Abdominal cramps, nausea, intestinal dysfunction, headache, weakness, dizziness, drowsiness, suppression of emotional responses, bradycardia, arrhythmia, decreased mental and physical performance, and hypokalemia are also possible.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging. 60 g or 75 g in packs with inner pouch;

1.5 g in a tea bag; 20 tea bags in a pack;

1.5 g in a tea bag; 20 tea bags in a pack with inner pouch.

Availability. Over-the-counter.

Manufacturer. JSC "Liktravy".

Manufacturer's name and address of place of business.

21 Kyivske Shose, Zhytomyr, Zhytomyr Oblast, 10001, Ukraine.