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Echinacea (Tablets, Granules, Solution, Juice) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Active Substance

Echinacea (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Herbal immunostimulant drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

A herbal preparation. The herb of Echinacea purpurea contains water-soluble immunostimulating polysaccharides (4-O-methylglucuronylarabinoxylans, acidic arabinorhamno-galactans); 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 function 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 of the body 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 preparations orally. Strictly adhere to the regimen specific to the prescribed dosage form.

For tablets, take 1-2 tablets three times daily. Swallow whole with water.

For oral solution and juice, administer 2-3 mL three times daily. Use the provided measuring dropper or cup for accurate dosing.

For granules, dissolve 5 granules in the mouth twice daily. Take 20 minutes before or 1 hour after meals.

Initiate treatment at the first sign of illness. For prevention, begin administration during periods of high epidemiological risk.

The standard course of treatment is 10 to 14 days. Do not exceed a continuous treatment duration of 8 weeks.

Allow an interval of at least two weeks before initiating a repeated course. Conduct repeated courses only on the explicit recommendation of a physician.

Adjust the duration of therapy based on clinical response and tolerability. Discontinue use if no improvement is observed within one week.

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 BP.

From the respiratory system bronchospasm with obstruction and attacks of bronchial asthma 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 2°C (36°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

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Tablets 200 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Echinacea purpurea extract 200 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Homeopathic Pharmacy, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Homeopathic granules: 8 g tubes or jars

Dosage Form, Packaging, and Composition

Homeopathic granules homogeneous, of regular spherical shape, white with a gray or cream tint, odorless.

100 g
Echinacea purpurea D3 1 g

Excipients : sugar pellets 100 g.

8 g – polymer tubes (1) – cardboard packs.
8 g – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Tablets 200 mg: 10, 20, 30, 40, 50, 60, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, without a score, from light brown to dark brown in color with lighter and darker inclusions.

1 tab.
Echinacea dry extract* 200 mg

* Echinacea purpurea herb extract (containing a sum of hydroxycinnamic acid derivatives calculated as cichoric acid 7%).

Excipients : lactose monohydrate – 150 mg, potato starch – 40 mg, povidone (low molecular weight medical polyvinylpyrrolidone) – 4 mg, colloidal silicon dioxide – 2 mg, magnesium stearate – 4 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Tablets 200 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets from grayish-brown with a greenish tint or light brown with a greenish tint to brown in color with lighter and darker inclusions, round, biconvex, with a score.

1 tab.
Echinacea purpurea herb extract* 200 mg

* Echinacea purpurea herb (Echinaceae purpureae herbae) dry extract, 5:1, corresponding to a sum of hydroxycinnamic acid derivatives calculated as cichoric acid 14 mg**.
** Extractant: water.

Excipients : lactose monohydrate, colloidal silicon dioxide (aerosil), croscarmellose sodium, povidone K-17, magnesium stearate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Dr. Rentschler Arzneimittel, GmbH (Germany)

For

HEXAL, AG (Germany)

Dosage Form

Bottle OTC Icon Echinacea Hexal Oral solution: bottle 50 ml

Dosage Form, Packaging, and Composition

Oral solution 1 bottle
Echinacea purpurea herb juice 50 ml

50 ml – dark glass bottles (1) complete with a dosing cup – cardboard packs.

Marketing Authorization Holder

Dr. Rentschler Arzneimittel, GmbH (Germany)

For

HEXAL, AG (Germany)

Dosage Form

Bottle OTC Icon Echinacea Hexal Oral solution: bottle 100 ml

Dosage Form, Packaging, and Composition

Oral solution 1 bottle
Echinacea purpurea herb juice 100 ml

100 ml – dark glass bottles (1) complete with a dosing cup – cardboard packs.

Marketing Authorization Holder

Dr. Rentschler Arzneimittel, GmbH (Germany)

For

HEXAL, AG (Germany)

Dosage Form

Bottle OTC Icon Echinacea Hexal Oral solution: bottle 150 ml

Dosage Form, Packaging, and Composition

Oral solution 1 bottle
Echinacea purpurea herb juice 150 ml

150 ml – dark glass bottles (1) complete with a dosing cup – cardboard packs.

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Renewal Tablets 200 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets

Echinacea purpurea herb extract 200 mg

10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (2 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (4 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (6 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
30 pcs. – jars – cardboard packs (30 pcs.) – Over-the-Counter
60 pcs. – jars – cardboard packs (60 pcs.) – Over-the-Counter
90 pcs. – jars – cardboard packs (90 pcs.) – Over-the-Counter

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

Dosage Form

Bottle OTC Icon Echinacea Vilar® Oral juice: 25 ml, 30 ml, 40 ml, or 50 ml bottle

Dosage Form, Packaging, and Composition

Herbal raw material 1 bottle
Echinacea purpurea liquid extract 100 %

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

Marketing Authorization Holder

Vilar Pez State Unitary Enterprise (Russia)

Dosage Form

Bottle OTC Icon Echinacea-Vilar Juice: 50 ml bottle

Dosage Form, Packaging, and Composition

Juice in the form of a transparent reddish-brown liquid, with a specific odor; the presence of a slight sediment is allowed.

1 bottle
Echinacea purpurea herb juice* 50 ml

Excipients : ethyl alcohol 96%.

* for the preparation of the drug, fresh Echinacea purpurea herb and 96% ethyl alcohol are used.
The content of ethyl alcohol in the drug is about 20%.

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

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