Echinaceae tincture

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEAE TINCTURE

Composition:

Active ingredient:

1 vial contains: dry tincture of purple coneflower rhizomes with roots (Echinacea purpureae rhizoma et radix) (1 : 10) (extraction solvent – 50 % ethanol) 50 ml;

Excipients, apart from extraction solvent, are absent.

Pharmaceutical form. Tincture.

Main physicochemical properties: transparent 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 increases 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 enhance metabolic processes, especially in the liver and kidneys. It has antiviral, antibacterial, and antimycotic properties.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Use as part of complex treatment of immunodeficiency states in chronic recurrent inflammatory diseases of various localization. Conditions following antibiotic therapy, cytostatic, immunosuppressive, or radiation therapy. Early symptoms of respiratory viral infections, prolonged antibiotic use. For local treatment of slowly healing wounds.

Contraindications.

Hypersensitivity to the components of the medicinal product or to plants of the Asteraceae (Compositae) family; connective tissue disorders (collagenoses), multiple sclerosis, and other autoimmune diseases.

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

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

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 action.

The drug is not recommended for simultaneous 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, for example, with certain antibacterial agents.

Special precautions for use.

The duration of treatment with the 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 must be shaken well before use.

Use during pregnancy or breastfeeding.

Pregnant women and women who are breastfeeding should not use the tincture, as the preparation contains alcohol.

Effect on ability to drive or operate machinery.

The preparation contains alcohol; therefore, caution should be exercised when driving or operating complex machinery.

Method of Administration and Dosage.

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 diluted 1:2 or 1:3 and administered at a dose of 5–10 drops 2–3 times daily, 30 minutes before meals.
For wound treatment, apply the tincture locally to affected areas. Externally, use for compresses and tampons. Dilute 20–60 drops of the tincture in 100 mL of 0.9% sodium chloride solution, moisten gauze with this solution, apply it to the wound, and cover with compress paper. Change the dressing twice daily.

Recommended duration of treatment with the drug is from 1 to 8 weeks.

Children.

The medicinal product should not be used in children under 12 years of age due to the presence of ethanol.

Overdose.

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

Adverse reactions.

Allergic reactions: skin redness, itching, rash, urticaria, Stevens-Johnson syndrome, angioneurotic 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).

With prolonged use (over 8 weeks), leukopenia may occur.

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.

50 ml in glass or polymer bottles, in a carton or without a carton.

Availability category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's location and address of business activity / applicant's location.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua.