ECHINACEA TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEAE TINCTURE (TINCTURAE CHINACEAE)

Composition:

Active substance: tincture of rhizomes with roots of purple coneflower (Echinaceae purpureae radix) (1:10) (extraction agent—50% ethanol).

One vial contains tincture of rhizomes with roots of purple coneflower (Echinaceae purpureae radix) (1:10) (extraction agent—50% ethanol) 20 ml, 25 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear reddish-brown liquid. Formation of sediment during storage 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. Inulin, lavulose, and betaine improve metabolic processes, especially in the liver and kidneys. It has antiviral, antibacterial, and antifungal properties.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

As part of complex treatment of immunodeficiency states in chronic recurrent inflammatory diseases of various localizations. Post-antibiotic, cytostatic, immunosuppressive, or radiation therapy conditions. Early symptoms of respiratory viral infections (RVIs); prolonged antibiotic use. Local treatment of slowly healing wounds.

Contraindications.

Hypersensitivity to the components of the drug or to plants of the Asteraceae (Compositae) family. Connective tissue diseases (collagenoses), multiple sclerosis, and other autoimmune diseases.

Progressive systemic diseases (tuberculosis, diabetes mellitus), blood leukocyte system disorders (leukemia, agranulocytosis), oncological diseases, rheumatism, AIDS, HIV infection, systemic lupus erythematosus, immunosuppression or immunodeficiency of various etiologies, and other chronic viral diseases.

Pregnancy or breastfeeding period. Children under 12 years of age.

Special precautions.

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

Interaction with other medicinal products and other forms of interaction.

Due to the immunostimulatory effect of echinacea, the drug may reduce the efficacy of agents exerting immunosuppressive effects.

The drug is not recommended for concomitant use with hepatotoxic agents such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

The product 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, may affect the elimination of drugs metabolized by enzymes of this system. Ethanol may cause a disulfiram-like reaction when used concomitantly with certain antibacterial agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Pregnant and breastfeeding women should not use the tincture, as the medicinal product contains alcohol.

Ability to affect reaction rate when driving or operating machinery.

The medicinal product contains ethanol; therefore, patients should refrain from driving or operating complex machinery.

Dosage and Administration.

To achieve a rapid effect at the beginning of treatment, adults should take 40 drops of the tincture, followed by an additional 20 drops within 2 hours. Afterwards, the drug should be taken 20 drops three times daily. The treatment course should not exceed 8 weeks. For children aged 12 years and older, the tincture should be administered diluted 1:2 or 1:3, at a dose of 5–10 drops 2–3 times daily, 30 minutes before meals. For wound treatment, apply the tincture topically to affected areas. Externally, use for compresses and tampons: dilute 20–60 drops of the tincture in 100 mL of isotonic sodium chloride solution, moisten gauze with this solution, apply it to the wound, and cover with compress paper. Change the dressing twice daily. The recommended duration of treatment with the drug is from 1 to 8 weeks.

Children.

The drug is not used in children under 12 years of age due to its ethanol content.

Overdose.

Nausea, vomiting, gastrointestinal disturbances, sleep disorders, increased nervous system excitation, and insomnia. Treatment is symptomatic.

Adverse reactions.

Allergic reactions: skin redness, itching, facial swelling, rash, urticaria, Stevens-Johnson syndrome, angioneurotic skin edema, Quincke's edema, anaphylactic shock.

Respiratory system disorders: dyspnea, bronchospasm with obstruction, asthma.

Central nervous system disorders: dizziness.

Cardiovascular system disorders: arterial hypotension.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

There have been isolated reports of association with autoimmune diseases (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans syndrome, Sjögren-Larsson syndrome with impaired renal tubular function).

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

Shelf life. 3 years.

Storage conditions.

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

Packaging.

20 ml, 25 ml, or 50 ml in glass bottles sealed with stoppers and caps; 50 ml in polymer bottles with caps; 50 ml in glass or polymer bottles in a carton; 20 ml, 25 ml, or 50 ml in glass bottles sealed with dropper stoppers; 20 ml, 25 ml, or 50 ml in glass bottles sealed with dropper stoppers, in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's name and address of manufacturing site.

75 Amosova Academician Street, Zaporizhzhia, Ukraine, 69063.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of Marketing Authorization Holder.

75 Amosova Academician Street, Zaporizhzhia, Ukraine, 69063.