Echinacea-astrafarm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEA-ASTRAFARM

Composition:

Active ingredient: 1 tablet contains 100 mg of dried juice of purple coneflower (Echinacea purpurea), expressed from the aerial parts during flowering, calculated to dry substance;

Excipients: sorbitol (E 420), sodium cyclamate, magnesium stearate, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, biconvex tablets with a score line on one side, grey in color with a slight creamy tint, containing specks of more intense coloration.

Pharmacotherapeutic group.

Immunostimulants. ATC code L03AX.

Pharmacological properties.

Pharmacodynamics.

A plant-derived biogenic stimulant that exerts immunomodulatory and anti-inflammatory effects, stimulates bone marrow hematopoiesis, thereby increasing the number of leukocytes and reticuloendothelial cells of the spleen. Predominantly activates cellular immunity, stimulates macrophage phagocytic activity and granulocyte chemotaxis, promotes cytokine release, increases macrophage production of interleukin-1, accelerates transformation of B-lymphocytes into plasma cells, enhances antibody production and T-helper activity. Increases nonspecific resistance of the body (including against influenza and herpes viruses).

Pharmacokinetics.

Well absorbed in the gastrointestinal tract. Excreted in urine and feces.

Clinical characteristics.

Indications.

As part of combination therapy in frequent relapses of infectious diseases of the respiratory and urinary tract.

At the first signs of acute respiratory viral infection (ARVI), prolonged use of antibiotics.

Contraindications.

Hypersensitivity to the drug or to other plants of the Asteraceae family (e.g., chamomile, calendula, dandelion); progressive systemic diseases (tuberculosis, diabetes mellitus); rheumatism; connective tissue diseases (collagenoses); multiple sclerosis and other autoimmune diseases (systemic lupus erythematosus); chronic viral diseases; AIDS or HIV infection; neoplasms; primary immunodeficiency; immunosuppression; disorders of the leukocyte blood system (leukemia, agranulocytosis).

Pregnancy or breastfeeding. Pediatric age under 12 years.

Interaction with other medicinal products and other forms of interaction.

Due to its immunostimulatory effect, echinacea may reduce the efficacy of drugs with immunosuppressive properties.

The drug is not recommended to be used concomitantly with agents having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

Special precautions for use.

The drug should not be used in patients with diabetes mellitus (1 tablet contains 577 mg of sorbitol, equivalent to 0.05 carbohydrate exchange units (CHU)).

The drug should be used with caution in patients with hereditary fructose intolerance.

If respiratory diseases recur frequently and are characterized by prolonged symptoms such as dyspnea, fever, or sputum containing pus or blood, medical advice must be sought.

If symptoms worsen or body temperature rises during treatment, immediate medical consultation is required.

In case of recurrent complaints related to urinary tract dysfunction, a medical examination is necessary and the patient should remain under regular medical supervision.

Patients predisposed to allergies should consult a physician before taking the drug due to the risk of anaphylactic reactions.

Concomitant administration of vitamins A, E, and C is recommended during treatment.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to affect reaction rate while driving or operating machinery.

Due to the possible effect of echinacea on the nervous system, the drug should be used with caution when driving or operating machinery.

Dosage and Administration.

Tablets can be sucked, chewed, or swallowed with liquid. The time of administration does not depend on meal times.

For adults and children aged 12 years and older, the recommended dose is 1 tablet (100 mg) twice daily. Maximum daily dose – 4 tablets (400 mg).

Duration of treatment – 10 days with daily use or 20 days when taking the drug every other day. The maximum duration of drug intake should not exceed 2 weeks (with daily administration). In chronic diseases, the treatment course may be repeated after an interval of 2–3 weeks.

Children.

The drug is not recommended for children under 12 years of age due to lack of experience with its use.

Overdose.

Symptoms: nausea, vomiting, diarrhea, increased excitability, sleep disturbances (insomnia).

Treatment: symptomatic therapy, gastric lavage, enteral sorbents.

Side effects.

Allergic reactions: skin redness, itching, rash, urticaria, facial swelling, Stevens-Johnson syndrome, angioneurotic edema, anaphylactic shock, Quincke's edema.

Respiratory system disorders: dyspnea, shortness of breath, bronchospasm with obstruction, bronchial asthma.

Central nervous system disorders: dizziness, sleep disturbances.

Cardiovascular system disorders: arterial hypotension.

Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain.

There have been isolated reports of association with autoimmune diseases (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans syndrome, Sjögren-Larsson syndrome with impaired renal tubular function).

With prolonged use (more than 8 weeks), leukopenia may occur.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 2 blisters per box.

Supply category.

Over-the-counter.

Manufacturer.

LLC "Astrafarm".

Manufacturer's address and location of business activity.

6 Kyivska Street, Vyshneve, Kyiv-Sviatoshyn District, 08132, Ukraine.