ECHINACEA PURPUREA TINCTURE

INSTRUCTIONS
for medical use of medicinal product

ECHINACEAE PURPUREAE TINCTURE

Composition:

Active ingredient: tincture of rhizomes and roots of echinacea (Rhizomata et radices Echinaceae purpureae);

One vial contains tincture of rhizomes and roots of echinacea (Rhizomata et radices Echinaceae purpureae) (1 : 10) (extraction solvent — 50% ethanol) 40 ml or 50 ml, or 100 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear reddish-brown liquid.

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 synthesis of interleukin-1, promotes transformation of B-lymphocytes into plasma cells, improves functions of T-helper cells. Polysaccharides inulin, levulose and betaine improve metabolic processes, especially in the liver and kidneys. The medicinal product has antiviral, antibacterial, antifungal properties.

Clinical characteristics.

Indications.

As part of complex treatment of immunodeficiency states in chronic recurrent inflammatory diseases of various localizations. Condition after antibiotic therapy, cytostatic, immunosuppressive, radiation therapy. Initial manifestations of acute respiratory viral infections (ARVI), during prolonged antibiotic use.

Contraindications.

Increased sensitivity to plants of the Asteraceae family or to components of the medicinal product, progressive systemic diseases such as tuberculosis, diabetes mellitus, blood leukocyte system disorders (e.g., leukemia, agranulocytosis), oncological diseases, rheumatism, connective tissue diseases (collagenoses), multiple sclerosis, systemic lupus erythematosus and other autoimmune diseases, AIDS, HIV infection, primary immunodeficiency, chronic viral diseases, primary immunosuppression.

Interaction with other medicinal products and other types of interactions.

Due to the immunostimulating effect of echinacea, the medicinal product may reduce the effectiveness of agents exerting immunosuppressive action.

It is not recommended to use simultaneously with drugs having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, steroid preparations.

The medicinal product contains ethanol, which may enhance absorption and pharmacological effect of certain sedative drugs and indirectly, by altering the activity of the cytochrome P450 system, affect 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.

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 tincture should be shaken before use.

Use during pregnancy or breastfeeding.

The medicinal product is not used during pregnancy and breastfeeding due to ethanol content.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product contains ethanol, which should be taken into account by individuals who drive vehicles or operate complex machinery.

Method of administration and dosage.

To achieve a rapid effect in acute conditions, at the beginning of treatment adults should take 40 drops of tincture, then another 20 drops within 2 hours. Afterwards, the medicinal product is taken 20 drops three times a day. Treatment course — no more than 8 weeks.

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

Children.

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

Overdose.

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

Treatment. Symptomatic therapy.

Adverse reactions.

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

Respiratory system: breathing difficulty, bronchospasm with obstruction, asthma.

Central nervous system: dizziness.

Cardiovascular system: arterial hypotension.

Gastrointestinal tract: 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.

5 years.

Storage conditions.

Store in original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C. Sediment formation may occur during storage.

Packaging.

40 ml, 50 ml, 100 ml glass bottles.

Category of release.

Over-the-counter.

Manufacturer.

PP "Kilaff".

Manufacturer's address and place of business.

6 Kharkivska Street, Sumy, Sumy region, 40035, Ukraine.