ECHINACEAE TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEAE TINCTURE

Composition:

Active substance: tincture of purple coneflower roots (Radices Echinaceae purpureae);

1 bottle contains tincture of purple coneflower roots (Radices Echinaceae purpureae) (1:5) (extraction solvent – ethanol 50%) 40 ml;

Excipients: none

Pharmaceutical form. Tincture.

Main physicochemical properties: yellow-brown liquid with an aromatic odor. Presence of sediment is permissible.

Pharmacotherapeutic group. Cytokines and immunomodulators. ATC code: L03A X.

Pharmacological properties.

Pharmacodynamics.

The complex of active substances enhances phagocytic activity of neutrophils and macrophages, stimulates interleukin-1 synthesis, promotes transformation of B-lymphocytes into plasma cells, and improves functions of T-helper cells. Polysaccharides inulin, levulose, and betaine improve metabolic processes, especially in the liver and kidneys. It possesses antiviral, antibacterial, and antimycotic properties.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. As part of complex treatment of immunodeficiency states in chronic recurrent inflammatory diseases of various localization. Condition following antibiotic therapy, cytostatic, immunosuppressive, or radiation therapy. Early signs of respiratory viral infections (ARVI); during prolonged antibiotic use.

Topically: treatment of slowly healing wounds.

Contraindications.

Hypersensitivity to active substances contained in the preparation, allergy to Compositae and other plants, diabetes mellitus. Should not be used in patients with progressive systemic diseases such as multiple sclerosis, hematopoietic system disorders (leukemia, agranulocytosis), oncological diseases, primary immunodeficiency, primary immunosuppression, chronic viral infections, other autoimmune diseases (systemic lupus erythematosus, tuberculosis, collagenoses, generalized atherosclerosis, AIDS, HIV infection).

Interaction with other medicinal products and other forms of interaction.

The preparation contains ethanol, which may enhance the absorption and pharmacological effect of certain sedative drugs and, indirectly, by altering the activity of the cytochrome P450 system, affect the elimination of drugs metabolized by enzymes of this system. Ethanol may cause a disulfiram-like reaction when used concomitantly, for example, with certain antibacterial agents.

Special precautions for use.

The duration of treatment with echinacea tincture should not exceed 8 weeks. During storage, the tincture may become cloudy and a precipitate may form, consisting of active polysaccharides; therefore, the bottle should be shaken before use.

Use during pregnancy and breastfeeding.

The drug should not be used during this period.

Ability to affect reaction rate when driving or operating machinery.

Patients should refrain from driving vehicles and operating potentially hazardous machinery.

Method of Administration and Dosage.

For rapid effect in acute conditions, at the beginning of treatment adults take 40 drops of the tincture, then another 20 drops within 2 hours. Afterwards, the medication should be taken 20 drops three times a day. The treatment course should not exceed 8 weeks.

Children aged 12 years and older are prescribed the tincture diluted 1:2 or 1:3, at a dose of 5–10 drops 2–3 times daily, 30 minutes before meals.

For wound treatment, the tincture is applied topically to affected areas. Externally used for compresses and tampons. 20–60 drops of the tincture are diluted in 100 mL of isotonic sodium chloride solution; gauze is moistened with this solution, applied to the wound, and covered with compress paper. Dressings should be changed twice daily. The recommended duration of treatment with the medication is from 1 to 8 weeks.

Children. Not to be used in children under 12 years of age due to ethanol content.

Overdose.

Symptoms: nausea, vomiting, gastrointestinal disturbances, sleep disorders, increased excitability, and insomnia.

Treatment: symptomatic therapy.

Side effects.

Echinacea may cause allergic reactions in predisposed patients. The frequency of occurrence is unknown. Hypersensitivity reactions may rarely occur, manifesting as skin redness, itching, facial swelling. Occasionally, rash, urticaria, Stevens-Johnson syndrome, angioneurotic skin edema, Quincke's edema, bronchospasm with obstruction, asthma, anaphylactic shock may develop. Dizziness, arterial hypotension, nausea, vomiting, diarrhea may occur infrequently.

There have been isolated reports linking Echinacea to autoimmune disorders (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans syndrome, Sjögren-Larsson syndrome with impaired renal tubular function).

Leukopenia may develop with prolonged use (more than 8 weeks).

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

40 ml in bottles.

Supply category. Over-the-counter.

Manufacturer.

Subsidiary enterprise "Agrofirm "Yan" of the private enterprise "Yan".

Manufacturer's address and location of business activity.

13643, Nemyrynci village, Ruzhyn district, Zhytomyr region, Ukraine, Lenin Street, 41.