Echinacea

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEA (ECHINACEA)

Composition:

Active substance: 1 vial contains liquid extract of purple coneflower herb (Echinacea purpurea) (1:2.7) (extraction solvent – ethanol 40%) – 50 ml;

Excipients: none.

Pharmaceutical form. Extract.

Main physicochemical characteristics: yellowish-brown liquid with a specific odor. Sediment formation may occur during storage.

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. The medicinal product has antiviral, antibacterial, and antimycotic properties.

Clinical characteristics.

Indications.

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

Topically: treatment of slowly healing wounds.

Contraindications.

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

Pregnancy or breastfeeding. Children under 12 years of age.

Interaction with other medicinal products and other types of interactions.

Due to the immunostimulatory effect of echinacea, the medicinal product may reduce the efficacy of drugs with immunosuppressive action.

The medicinal product is not recommended for concomitant use with drugs having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

The medicinal 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, 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 extract should not exceed 8 weeks. During storage, the extract may become cloudy and sediment may form, consisting of active polysaccharides; therefore, the medicinal product must be shaken before use.

Use during pregnancy or breastfeeding.

The product should not be used during pregnancy or breastfeeding due to its ethanol content.

Ability to affect reaction speed when driving or operating machinery.

The product contains ethanol; therefore, driving or operating complex machinery requiring high concentration should be avoided.

Method of Administration and Dosage.

To achieve a rapid effect in acute conditions, at the beginning of treatment adults should take 40 drops of the extract, then 20 drops every 2 hours for the first 2 hours. Afterwards, the drug should be taken 20 drops three times daily. Treatment duration should not exceed 8 weeks.

For children aged 12 years and older, the extract 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 extract topically to affected areas. Externally, use for compresses and tampons. Dilute 20–60 drops of the extract 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 treatment duration with the drug is from 1 to 8 weeks.

Children.

The drug should not be used in children under 12 years of age.

Overdose.

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

Treatment: symptomatic therapy.

Adverse Reactions.

Echinacea may cause allergic reactions in predisposed patients.

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

Respiratory system: dyspnea, 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 (more than 8 weeks), leukopenia may occur.

Shelf Life.

4 years.

Storage Conditions.

Store in a place inaccessible to children.

Store in the original packaging at a temperature not exceeding 25 °C.

Packaging.

50 ml in a bottle. 1 bottle per cardboard box.

Prescription Status.

Over-the-counter.

Manufacturer.

LLC "EURASIA".

Manufacturer's Location and Address of Business Activity.

Ukraine, 38600, Poltava region, Kotelva district, urban-type settlement Kotelva, Ryntkova St., 32.

Marketing Authorization Holder.

LLC "EURASIA".

Address of the Marketing Authorization Holder.

Ukraine, 38600, Poltava region, Kotelva district, urban-type settlement Kotelva, Poltava Highway, 210A.

INSTRUCTION

for Medical Use of Medicinal Product

ECHINACEA

(ECHINACEA)

Composition:

Active ingredient: 1 bottle contains liquid extract of purple coneflower herb (Echinacea purpurea) (1:2.7) (extraction agent – ethanol 40%) – 50 ml;

Excipients: none.

Pharmaceutical Form. Extract.

Main physicochemical properties: yellow-brown liquid with a specific odor. Sediment formation may occur during storage.

Pharmacotherapeutic Group.

Cytokines and immunostimulants. ATC Code L03AX.

Pharmacological Properties.

Pharmacodynamics.

The active components complex enhances phagocytic activity of neutrophils and macrophages, stimulates interleukin-1 synthesis, promotes transformation of B-lymphocytes into plasma cells, improves T-helper cell function. Polysaccharides, inulin, levulose, and betaine improve metabolic processes, especially in the liver and kidneys. The medicinal product has antiviral, antibacterial, and antifungal properties.

Clinical Characteristics.

Indications.

As part of complex therapy for immunodeficiency states in chronic recurrent inflammatory diseases of various localizations. Post-antibiotic therapy condition, post-cytostatic, immunosuppressive, or radiation therapy. Early symptoms of acute respiratory viral infections, prolonged antibiotic use.

Topically: treatment of slowly healing wounds.

Contraindications.

Hypersensitivity to plants of the Asteraceae family or to any component of the drug; progressive systemic diseases (tuberculosis, diabetes mellitus); leukocyte blood system disorders (e.g., leukemia, agranulocytosis); oncological diseases; rheumatism; connective tissue diseases (collagenoses); multiple sclerosis and other autoimmune diseases; AIDS; HIV infection; systemic lupus erythematosus; primary immunosuppression or primary immunodeficiency; other chronic viral infections.

Pregnancy or breastfeeding. Children under 12 years of age.

Interaction with Other Medicinal Products and Other Types of Interactions.

Due to the immunostimulatory effect of echinacea, the medicinal product may reduce the efficacy of immunosuppressive agents.

The product is not recommended for concomitant use with hepatotoxic drugs such as amiodarone, methotrexate, ketoconazole, and steroid preparations. The product contains ethanol, which may enhance the absorption and pharmacological effect of certain sedatives and, indirectly, by altering cytochrome P450 system activity, 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.

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

Use during pregnancy or breastfeeding.

The product should not be used during pregnancy or breastfeeding due to the presence of ethanol.

Ability to Affect Reaction Speed When Operating Vehicles or Machinery.

The product contains 40% ethanol; therefore, patients should refrain from driving vehicles or operating complex machinery requiring high concentration.

Method of Administration and Dosage.

For rapid effect in acute conditions, initially adults should take 40 drops of the extract, followed by an additional 20 drops within 2 hours. Subsequently, take 20 drops three times daily. Treatment course – no more than 8 weeks.

For children aged 12 years and older, administer the extract diluted 1:2 or 1:3, 5–10 drops 2–3 times daily, 30 minutes before meals.

For wound treatment, apply the extract topically to affected areas. For external use in compresses and tampons: dilute 20–60 drops of extract in 100 ml of 0.9% sodium chloride solution, soak gauze with this solution, apply to the wound, and cover with compress paper. Change the dressing twice daily. Recommended treatment duration – from 1 to 8 weeks.

Children.

Do not use in children under 12 years of age.

Overdose.

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

Treatment: symptomatic therapy.

Adverse Reactions.

Echinacea may cause allergic reactions in predisposed patients.

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

Respiratory system: dyspnea, 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 (more than 8 weeks), leukopenia may occur.

Shelf Life.

4 years.

Storage Conditions.

Store in a place inaccessible to children.

Store in the original packaging at a temperature not exceeding 25 °C.

Packaging.

50 ml in a bottle. 1 bottle per cardboard box.

Prescription Status.

Over-the-counter.

Manufacturer.

LLC "EURASIA".

Manufacturer's Location and Address of Business Activity.

Ukraine, 38600, Poltava region, Kotelva district, urban-type settlement Kotelva, Ryntkova St., 32.

Marketing Authorization Holder.

LLC "EURASIA".

Address of the Marketing Authorization Holder.

Ukraine, 38600, Poltava region, Kotelva district, urban-type settlement Kotelva, Poltava Highway, 210A.