Esberitox

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESBERITOX (Esberitox®)

Composition:

Active substances: 1 tablet contains 3.2 mg of dry extract (4–9:1) from a raw material mixture: rhizomes of Baptisia tinctoria L.; root of Echinacea purpurea Moench; roots of Echinacea pallida Nutt.; young shoots and leaves of Thuja occidentalis L.

Extraction solvent: ethanol 30% (v/v);

Excipients: lactose; macrogol 6000; magnesium stearate; sucrose.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: beige to light brown, round, slightly convex on both sides tablets, approximately 9 mm in diameter and approximately 4 mm thick, without a score line.

Pharmacotherapeutic group.

Other immunostimulants. ATC Code: L03A X.

Pharmacological properties.

Pharmacodynamics.

In various preclinical models at different sites of action, Esberitox demonstrates immune system stimulation.

In the case of viral colds, clinical stimulation of the body's defense mechanisms results in alleviation of symptoms and reduced duration of illness.

Pharmacokinetics.

It is not possible to clearly attribute the observed pharmacodynamic effects to individual defined components, since Esberitox tablets are a complex mixture of several plant substances. Information regarding the pharmacokinetics of the drug is lacking.

Clinical characteristics.

Indications.

For strengthening the body's resistance as supportive therapy in the complex treatment of viral respiratory infections.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients of the medicinal product. The medicinal product should not be used in patients with progressive systemic diseases (tuberculosis and sarcoidosis); in autoimmune diseases (collagenosis, multiple sclerosis); in immunodeficiency states (AIDS, HIV infection); in immunosuppressive conditions caused by the use of cytostatic drugs or immunosuppressants, e.g. after transplantation; in hematological disorders (leukemia, agranulocytosis).

Interaction with other medicinal products and other forms of interaction.

Interaction with other medicinal products is unknown.

Appropriate studies on the interaction of the medicinal product with other medicinal products have not been conducted.

Special precautions for use.

If symptoms worsen or persist for longer than 10 days, or if dyspnea, fever, purulent or bloody discharge occur, medical advice should be sought.

Esberitox tablets should not be used in patients with rare hereditary conditions such as galactose intolerance, fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, or lactase deficiency.

Use during pregnancy or breastfeeding.

There is insufficient data on the use of Esberitox in pregnant women. Reproductive toxicity of the drug has not been sufficiently studied in animal experiments. Since the safety of Esberitox tablets during pregnancy has not been established, the drug should be used only after careful assessment of the benefit-risk ratio for mother and fetus (child).

There is no information available on the excretion of specific components of Esberitox in human breast milk or their potential adverse effects on the breastfed infant. Precaution: Esberitox tablets should not be used during breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Unknown.

Dosage and Administration

For adults and children aged 12 years and older: take 4–6 tablets three times daily.

For children aged 7 to 11 years: take 2–3 tablets three times daily.

For children aged 4 to 6 years: take 1–2 tablets three times daily.

Esberitox, tablets must not be administered to children under 4 years of age due to insufficient safety data.

There are no data available regarding specific dosage recommendations in patients with renal or hepatic impairment.

The tablets should be taken with a large amount of liquid, preferably water, or allowed to dissolve in the oral cavity in the morning, at noon, and in the evening.

Duration of treatment depends on the course of the underlying disease. Treatment should be initiated immediately upon onset of symptoms and continued until symptoms resolve. Esberitox tablets should not be used for longer than 10 days.

Children

The medication is intended for children aged 4 years and older.

Overdose

Overdose has not been observed.

Side effects.

The assessment of side effects is based on the following frequency categories:

very common: ≥ 1/10;

common: ≥ 1/100 to < 1/10;

uncommon: ≥ 1/1,000 to < 1/100;

rare: ≥ 1/10,000 to < 1/1,000;

very rare: < 1/10,000;

not known: frequency cannot be determined from available data.

Immune system disorders:

Hypersensitivity reactions, including skin rash, pruritus, facial swelling, dyspnea, hypotension.

Gastrointestinal disorders:

Abdominal pain, vomiting, diarrhea.

General disorders:

Dizziness.

Frequency data unavailable.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C. Keep out of reach of children.

Packaging.

20 tablets in a blister; 2, 3, 5, or 10 blisters per cardboard box.

Category of supply. Over-the-counter (without prescription).

Manufacturer.

Schaper & Brümmer GmbH & Co. KG.

Manufacturer's address and place of business.

Bahnhofstrasse 35, 38259 Salzgitter, Germany.