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Echinaceae tinctura (Extract, Herbal raw material, Tincture) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Active Substance

Echinacea (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

A herbal remedy. Purple coneflower herb contains water-soluble immunostimulating polysaccharides (4-O-methylglucuronoarabinoxylans, acidic arabinorhammogalactans); essential oils (components include germacrene alcohol, borneol, bornyl acetate, pentadeca-8-en-2-one, germacrene D, caryophyllene, caryophyllene epoxide); flavonoids (ferulic acid and its derivatives, including cichoric acid, methyl ester of cichoric acid, 2-O-caffeoyl-3-O-feruloyl-tartaric acid, 2,3-O-diferuloyl-tartaric acid, 2-O-caffeoyl-tartaric acid); alkamides; polyenes.

It has immunomodulatory and anti-inflammatory effects. Polysaccharides increase the phagocytic activity of neutrophils and macrophages and stimulate the production of interleukin-1. The complex of active substances induces the transformation of B-lymphocytes into plasma cells and improves the functions of T-helpers. Due to inulin, levulose, and betaine, it improves metabolic processes, especially in the liver and kidneys. It increases the body’s nonspecific resistance (including to influenza and herpes pathogens). It has a capillary-protective effect.

Indications

Enhancement of nonspecific defense factors in uncomplicated acute infectious diseases and in predisposition to frequent colds; for immune stimulation in patients with uncomplicated acute infectious diseases (as an auxiliary treatment); prevention of ARVI and influenza; as an auxiliary medicinal product during prolonged antibiotic therapy of chronic infectious diseases. Prevention and as part of complex therapy of recurrent infectious diseases of the respiratory tract and urinary tract.

ICD codes

ICD-10 code Indication
J06.9 Acute upper respiratory infection, unspecified
J10 Influenza due to identified seasonal influenza virus
Z29.8 Other specified prophylactic measures
ICD-11 code Indication
1E30 Influenza due to identified seasonal influenza virus
CA07.0 Acute upper respiratory tract infection of unspecified site
QC05.Z Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer Echinacea tincture orally. Dilute the required dose in a small volume of water prior to ingestion.

For acute infection treatment in adults and adolescents over 12 years, take 2-3 mL of tincture three times daily at the first sign of symptoms.

Continue this dosage for a maximum of 10 days. Do not exceed this treatment duration without medical supervision.

For preventive use during periods of high contagion risk, take 2-3 mL of tincture three times daily.

Limit continuous prophylactic use to a maximum of 8 weeks. A treatment-free interval is mandatory after this period.

Adhere strictly to the recommended dosage. Higher doses do not enhance efficacy and may increase the risk of adverse effects.

For herbal raw material, prepare an infusion according to the manufacturer’s instructions. Typically, use 1-2 grams of crushed herb per cup of boiling water.

Steep for 10-15 minutes, then strain. Drink one cup of the prepared infusion up to three times daily.

Initiate therapy at the earliest sign of illness for optimal effect. The immunostimulatory action is most pronounced at the onset of infection.

Discontinue use immediately and consult a physician if signs of hypersensitivity, such as skin rash or breathing difficulties, occur.

Do not use in children under 12 years of age. The dosage for this age group is not established and use is contraindicated.

Adverse Reactions

From the digestive system: nausea, vomiting, stool disorders.

From the hematopoietic system: leukopenia (with continuous use for more than 8 weeks).

From the immune system: skin rash, itching, angioneurotic edema, Quincke’s edema, Stevens-Johnson syndrome, anaphylactic shock. Allergic reactions are possible in patients with atopy. A relationship between the occurrence of adverse events and autoimmune diseases (diffuse encephalitis, erythema nodosum, immunothrombocytopenia, Evans syndrome, Sjögren’s syndrome with renal tubular dysfunction) has been reported.

From the cardiovascular system: dizziness, decreased blood pressure.

From the respiratory system: bronchospasm with obstruction and asthma attacks as manifestations of hypersensitivity reactions.

Allergic reactions: hyperemia, edema.

Other: chills.

Contraindications

Hypersensitivity to Echinacea and plants of the Asteraceae family; progressive systemic and autoimmune diseases (including tuberculosis, sarcoidosis, collagenosis, multiple sclerosis); immunodeficiency (AIDS or HIV infection) and immunosuppression (including cytostatic anticancer therapy; history of organ or bone marrow transplantation); blood diseases (agranulocytosis, leukemia); allergic diseases (urticaria, atopic dermatitis, bronchial asthma); children under 12 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

Patients with recurrent infectious diseases of the respiratory tract require regular medical supervision.

Patients with atopy have an increased risk of developing anaphylactic shock.

Drug Interactions

With the simultaneous use of Echinacea preparations with immunosuppressants, a mutual weakening of the effect occurs.

Simultaneous use with antibiotics and other antimicrobial agents is possible.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Begrif, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae tinctura Tincture: bottle and dropper bottle 25 mL, 30 mL, or 50 mL

Dosage Form, Packaging, and Composition

Tincture in the form of a clear liquid from greenish-yellow to yellowish-brown; cloudiness or sediment formation is possible during storage.

1 L
Purple coneflower herb 200 g

Excipients: ethanol (ethyl alcohol) 40% – sufficient quantity to obtain 1000 ml of the preparation.

25 ml – bottles (1) of orange glass – cardboard packs.
25 ml – dropper bottles (1) of orange glass – cardboard packs.
30 ml – bottles (1) of orange glass – cardboard packs.
30 ml – dropper bottles (1) of orange glass – cardboard packs.
50 ml – bottles (1) of orange glass – cardboard packs.
50 ml – dropper bottles (1) of orange glass – cardboard packs.

Marketing Authorization Holder

Waltham-Pharmacy, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae tinctura Tincture: bottle 50 mL or 100 mL, jars 100 mL

Dosage Form, Packaging, and Composition

Tincture in the form of a clear and opalescent liquid from greenish-yellow to yellowish-brown; sediment may form during storage.

1 L
Purple coneflower herb 200 g

Excipients: ethanol 70% – sufficient quantity to obtain 1 L.

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae tinctura Tincture: bottle 50 mL, carboy 0.9 kg, canister 4.5 kg, 9 kg, or 18 kg

Dosage Form, Packaging, and Composition

Tincture in the form of a clear or opalescent liquid from greenish-yellow to yellowish-brown; sediment may form during storage.

1 L
Purple coneflower herb 200 g

Excipients: ethanol 40% – sufficient quantity to obtain 1 L of the preparation.

50 ml – glass bottles (1) – cardboard packs.
0.9 kg – polymer bottles (1) – cardboard packs (for hospitals).
4.5 kg – polymer canisters (1) – cardboard packs (for hospitals).
9 kg – polymer canisters (1) – cardboard packs (for hospitals).
18 kg – polymer canisters (1) – cardboard packs (for hospitals).

Note:
For the preparation of ethanol (ethyl alcohol) 40% the following is required: ethanol 95% – 360 g, purified water – 640 g.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Manufactured By

Pharmaceutical Factory Of St. Petersburg, PJSC (Russia)

Or

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae tinctura Tincture: bottle 25 mL, 50 mL, or 100 mL

Dosage Form, Packaging, and Composition

Tincture 100 ml
Purple coneflower herb 20 g

25 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Ecolab, JSC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae tinctura Tincture: bottle and dropper bottle 25 mL, bottle 50 mL or 100 mL.

Dosage Form, Packaging, and Composition

Tincture 100 ml
Purple coneflower herb 20 g

25 ml – dark glass bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Altayvitamins, JSC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae purpurae extractum liquidum Extract for oral administration: bottle 100 ml

Dosage Form, Packaging, and Composition

Extract for oral administration (liquid) 1 bottle
Purple coneflower extract 100 ml

100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Lek S+, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae purpurae herba Herb powder 2 g: filter bags 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Herb powder 1 filter bag
Purple coneflower extract 2 g

2 g – filter bags (10) – cardboard packs.
2 g – filter bags (20) – cardboard packs.

Marketing Authorization Holder

Lek S+, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinaceae purpurae herba Herb cut: packs 30 g, 50 g, 75 g or 100 g

Dosage Form, Packaging, and Composition

Cut herb 1 pack
Purple coneflower extract 100%

30 g – paper bags (1) – cardboard packs.
50 g – paper bags (1) – cardboard packs.
75 g – paper bags (1) – cardboard packs.
100 g – paper bags (1) – cardboard packs.

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