Echinacin^® Liquidum (Solution) Instructions for Use

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Echinacea (BP British Pharmacopoeia)

Dosage Form

Echinacin® Liquidum

Oral solution: fl. 50 or 100 ml with a measuring cup

Dosage Form, Packaging, and Composition

Oral solution – a transparent or slightly to moderately turbid light brown liquid with a characteristic odor; the formation of a slight flocculent sediment during storage is acceptable.

Excipients : ethanol 96% – 18.1 g, water – 1.9 g.

50 ml – dark glass dropper bottles (1) in a cardboard box with a measuring cup (with graduations of 1.25 ml, 2 ml, and 2.5 ml).
100 ml – dark glass dropper bottles (1) in a cardboard box with a measuring cup (with graduations of 1.25 ml, 2 ml, and 2.5 ml).

Clinical-Pharmacological Group

Herbal immunostimulant drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

The drug has an immunostimulating and anti-inflammatory effect.

It increases the phagocytic activity of neutrophils and macrophages; stimulates the production of interleukin-1; induces the transformation of B-lymphocytes into plasma cells; enhances the function of T-helpers; stimulates bone marrow hematopoiesis, resulting in an increase in the number of leukocytes and cells of the reticuloendothelial system.

Indications

• Prevention of acute respiratory viral diseases.

As part of complex therapy

• Acute and chronic recurrent infectious diseases of the upper respiratory tract and urinary tract;
• Secondary immunodeficiency states of various etiologies (infections, radiation, chemotherapy).

ICD codes

Dosage Regimen

To be taken orally, diluted or followed by a sufficient amount of liquid.

Children from 4 to 6 years – 1.25 ml 3 times a day.

Children from 6 to 12 years – 2.0 ml 3 times a day.

Adults and children over 12 years – 2.5 ml 3 times a day.

The course of treatment should not exceed 2 weeks. A doctor’s consultation is necessary to determine the advisability of subsequent treatment courses.

Adverse Reactions

In very rare cases, allergic reactions (hyperthermia, facial edema, dyspnea), dizziness, and decreased blood pressure may develop.

Contraindications

• Hypersensitivity to the components of the drug (including plants of the Asteraceae family);
• Systemic and autoimmune diseases (tuberculosis, leukemia, multiple sclerosis, AIDS and HIV infection, systemic lupus erythematosus, oncological diseases);
• Children under 4 years of age;
• Pregnancy;
• Lactation period.

Use with caution in liver and/or kidney diseases, brain diseases, traumatic brain injury, compensated diabetes mellitus (because the dosage form contains sucrose).

Use in Pregnancy and Lactation

Use with caution in the first trimester of pregnancy and during breastfeeding. In the second and third trimesters of pregnancy, treatment with the drug should be carried out under medical supervision.

Use in Hepatic Impairment

Use with caution in liver diseases.

Use in Renal Impairment

Use with caution in kidney diseases.

Pediatric Use

Contraindication: children under 4 years of age.

Special Precautions

The drug contains about 22% ethanol. The risk group includes patients with epilepsy, alcoholism, impaired liver function, brain diseases, brain damage, and traumatic brain injury.

When taking the drug with cephalosporin derivatives or ethanol-containing beverages, nausea, sweating, headache, and a sensation of palpitations may occur.

The bottle must be shaken before use.

Influence on the ability to drive vehicles and mechanisms

Caution should be exercised when driving vehicles or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms (when taking large doses of the oral solution): nausea, vomiting, diarrhea, insomnia, increased excitability of the nervous system.

Treatment : symptomatic

Drug Interactions

It can be used simultaneously with antibiotics and other antimicrobial drugs.

The alcohol contained in the composition may affect the effectiveness of other drugs (in particular, reduce the activity of immunosuppressants, change the effect of cephalosporin derivatives and ethanol-containing beverages).

Storage Conditions

Store in a light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F). Shelf life after opening is 12 weeks.

Shelf Life

Shelf life – 5 years. Do not use after the expiration date printed on the packaging.

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.