Instructions for Esberitox tablets 3.2 mg blister No. 60
Composition
active ingredients: 1 tablet contains 3.2 mg of dry extract (4-9:1) from a mixture of raw materials: rhizomes of Bapticia tinctoria L; roots of Echinacea purpurea Moench; roots of Echinacea pallida Nutt; young shoots and leaves of Thuja occidentalis L.
Extractant: ethanol 30% (v/v);
Excipients: lactose; macrogol 6000; magnesium stearate; sucrose.
Dosage form
Pills.
Main physicochemical properties: beige to light brown, round, slightly convex on both sides tablets, approximately 9 mm in diameter, approximately 4 mm thick, without a dividing line.
Pharmacotherapeutic group
Other immunostimulants. ATX code L03A X.
Pharmacological properties
Pharmacodynamics
In various preclinical models at different sites of action, Esberitox demonstrates stimulation of the immune system.
In the case of viral colds, clinical stimulation of the body's defenses is manifested in the relief of symptoms and reduction of the duration of the disease.
Pharmacokinetics
It is not possible to clearly attribute the relevant pharmacodynamic results to the individually identified components, since Esberitox tablets are a complex mixture of several herbal substances. Information on the pharmacokinetics of the drug is not available.
Indication
To strengthen the body's resistance as a supportive therapy in the complex treatment of viral colds.
Contraindication
Hypersensitivity to the active substances or to any of the excipients of the drug. The drug should not be used in patients with progressive systemic diseases (tuberculosis and sarcoidosis); autoimmune diseases (collagenosis, multiple sclerosis); immunodeficiency states (AIDS, HIV infection); immunosuppressive states caused by the use of cytostatic drugs or immunosuppressants, for example, after transplantation; hematological diseases (leukemia, agranulocytosis).
Interaction with other medicinal products and other types of interactions
Interactions with other drugs are unknown.
Appropriate studies on the interaction of the drug with other drugs have not been conducted.
Application features
If symptoms worsen or persist for longer than 10 days, or if shortness of breath, fever, purulent or bloody discharge occurs, you should consult a doctor.
Patients with rare hereditary problems of galactose intolerance, fructose intolerance, sucrase-isomaltase deficiency, lactase deficiency or glucose-galactose malabsorption should not take Esberitox tablets.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Use during pregnancy or breastfeeding
There are no sufficient data on the use of Esberitox in pregnant women. The reproductive toxicity of the drug has not been sufficiently studied in animal studies. Since the safety of Esberitox tablets during pregnancy has not been proven, the drug should be taken after a careful assessment of the benefit to the mother/risk to the fetus (child).
There is no information on the excretion of certain components of Esberitox in breast milk and their negative effects on the breastfed infant. Warning: Esberitox tablets should not be taken during breastfeeding.
Method of administration and doses
Adults and children over 12 years of age should take 4-6 tablets 3 times a day.
Children aged 7 to 11 years: 2-3 tablets 3 times a day.
Children aged 4 to 6 years: 1-2 tablets 3 times a day.
Esberitox tablets should not be given to children under 4 years of age due to insufficient data on the safety of the drug.
There are no data on specific dosage recommendations for renal/hepatic impairment.
The tablets should be taken with plenty of liquid, preferably water, or dissolved in the mouth in the morning, at lunchtime, and in the evening.
The duration of treatment depends on the course of the underlying disease. Treatment should be started immediately after the symptoms appear and continued until they disappear. Esberitox tablets should not be used for longer than 10 days.
Children
The drug is intended for children aged 4 years and older.
Overdose
Overdose was not observed.
Adverse reactions
The assessment of side effects is based on the following frequency indicators:
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 estimated from the available data.
On the part of the immune system:
Hypersensitivity reactions, including skin rash, itching, facial swelling, shortness of breath, low blood pressure.
From the gastrointestinal tract:
Abdominal pain, vomiting, diarrhea.
General violations:
Dizziness.
Frequency data are not available.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
20 tablets in a blister, 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Shaper & Brümmer GmbH & Co. KG.
Location of the manufacturer and its business address
Bahnhofstrasse 35, 38259 Salzgitter, Germany.
