Echinacea-lubnifarm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEA-LUBNIPHARM

Composition:

Active substance: 1 tablet contains 100 mg of Echinacea purpurea root extract, dry (calculated as 9% content of total hydroxycinnamic acids) (extraction solvent – 40% ethanol (v/v)).

Excipients: microcrystalline cellulose; lactose monohydrate; potato starch; methylcellulose; calcium stearate; sodium starch glycolate (type A); colloidal anhydrous silicon dioxide; hypromellose; Candurin Silver Lustre (pearlescent); titanium dioxide (E 171); food color Red A (E 129).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: intact, regular, round cylindrical tablets with convex upper and lower surfaces, coated with a pink film layer, smooth surface, showing a light brown core with dark specks upon breaking, surrounded by a single continuous coating layer.

Pharmacotherapeutic group.

Immunostimulants. ATC code L03AX.

Pharmacological properties.

Pharmacodynamics.

A plant-derived biogenic stimulant with immunomodulatory and anti-inflammatory effects, stimulates bone marrow hematopoiesis, thereby increasing the number of leukocytes and cells of the reticuloendothelial system of the spleen. Primarily activates cellular immunity, enhances phagocytic activity of macrophages 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 pathogens).

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.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

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

The drug is not recommended for concomitant use with agents having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

An enhanced or diminished effect cannot be excluded when co-administering drugs whose elimination depends on the activity of cytochrome P450, specifically CYP3A or CYP1A2 isoenzymes.

Special precautions for use

If respiratory diseases recur frequently and have prolonged symptoms manifested by difficulty breathing, fever, expectoration with pus or blood admixtures, medical advice must be sought.

If disease symptoms worsen or body temperature rises during treatment, immediate medical advice must be sought.

In case of recurrent complaints regarding urinary tract dysfunction, a medical examination is necessary and the patient must remain under medical supervision.

Patients prone to allergies should consult a physician before taking the medicine, as there is a risk of anaphylactic reactions.

Use with caution in patients with diabetes mellitus.

The drug is recommended to be taken in combination with vitamins A, E, and C.

The preparation contains lactose and therefore should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding

Not recommended.

Ability to influence reaction speed when driving or operating machinery

Given the possible effect of echinacea on the nervous system, the medicine 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 food intake.

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

For children aged 6 to 12 years: 1 tablet (100 mg) once daily. Maximum daily dose for this age group – 1 tablet (100 mg).

Duration of treatment – 10 days with daily administration or 20 days if taking the drug every other day. Maximum duration of treatment – no more than 2 weeks (with daily use). In chronic diseases, the treatment course may be repeated after 2–3 weeks.

Children.

The drug is not recommended for children under 6 years of age due to lack of experience with its use.

Overdose.

Symptoms: nausea, vomiting, diarrhea, insomnia, increased nervous system excitability.

Treatment: symptomatic therapy, gastric lavage, enteral sorbents.

Side effects.

Immune system disorders: hypersensitivity reactions, including skin rash, redness of the skin, pruritus, angioneurotic edema, urticaria, Stevens–Johnson syndrome, dyspnea, bronchospasm with obstruction, anaphylactic shock.

Respiratory system disorders: difficulty breathing, dyspnea, bronchospasm with obstruction, bronchial asthma.

Nervous system disorders: dizziness, sleep disturbances.

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

Vascular disorders: decreased blood pressure.

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

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

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

Tablets 100 mg, pack of 20 (10 × 2), 30 (10 × 3) in blisters.

Availability. Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

16, Barvinkova Str., Lubny, Poltava region, 37500, Ukraine.