Imunoplus

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMUNOPLUS (IMMUNOPLUS)

Composition:

Active substance: 1 tablet contains 100 mg of dry pressed juice of purple coneflower (Echinacea purpurea L.);

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

Pharmaceutical form. Tablets.

Main physico-chemical properties: round, biconvex tablets of pale yellow-brown to brown color with specks.

Pharmacotherapeutic group. Immunostimulants. ATC code L03AX.

Pharmacological Properties

Pharmacodynamics

A plant-derived biogenic stimulant with immunomodulatory and anti-inflammatory effects. It stimulates bone marrow hematopoiesis, thereby increasing the number of leukocytes and cells of the reticuloendothelial system in the spleen. It primarily activates cellular immunity, enhances 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 non-specific resistance of the body (including against influenza and herpes virus agents).

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 tracts.

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

Contraindications.

Hypersensitivity to plants of the Asteraceae family (medicinal chamomile, arnica, calendula officinalis, dandelion) or to any other component of the medicinal product.

Progressive systemic disorders (tuberculosis, sarcoidosis); hematopoietic system disorders (leukosis, leukemia, agranulocytosis); autoimmune diseases, including multiple sclerosis, collagenoses, systemic lupus erythematosus; chronic viral diseases; oncological diseases; AIDS or HIV infection; immunosuppression or immunodeficiency of various etiologies; diabetes mellitus; rheumatism.

Children under 12 years of age. Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Due to its immunostimulatory effect, echinacea may reduce the effectiveness of medicinal products with immunosuppressive action.

The medicinal product is not recommended for simultaneous use with medicinal products having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, and steroid medicinal products.

Enhancement or reduction of effect cannot be excluded when used concomitantly with medicinal products whose elimination depends on the activity of cytochrome P450, isoenzymes CYP3A or CYP1A2.

Special precautions for use

Patients with atopic diseases or a predisposition to allergies should consult a physician before starting the medication, as there is a risk of developing anaphylactic reactions.

Immunoplus contains sorbitol: 1 tablet contains 570 mg of sorbitol, equivalent to 0.05 bread units (XE). When used according to the recommended dosage, each dose delivers from 1.14 g to 3.42 g of sorbitol. If a patient has known intolerance to certain sugars, medical advice must be sought before taking this medicinal product. Immunoplus should not be used in hereditary fructose intolerance. The medicinal product may also have a mild laxative effect.

If respiratory diseases recur frequently and are associated with prolonged symptoms such as difficulty breathing, fever, purulent or bloody sputum, medical advice must be sought immediately.

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

In case of recurrent complaints related to urinary tract function, medical evaluation is necessary, and the patient should undergo regular medical check-ups.

The use of this medicinal product is recommended to be combined with vitamins A, E, and C.

Use during pregnancy or breastfeeding

Do not use.

Ability to influence reaction speed when driving or operating machinery

Specific studies are lacking; however, dizziness may occur during use of the medicinal product. Therefore, Immunoplus should be used with caution when driving or operating machinery.

Dosage and Administration

Tablets can be sucked, chewed, or swallowed with liquid (1 glass).

The time of tablet intake is independent of food intake.

For adults and children aged 12 years and older: take 1 tablet (100 mg) twice daily.

Maximum daily dose – 4 tablets (400 mg).

Treatment duration – 10 days with daily use, or 20 days when using the medication every other day. The duration of medication use should not exceed 2 weeks (with daily administration). In chronic diseases, the treatment course may be repeated after an interval of 2–3 weeks (after consultation with a physician).

Children. The drug is not recommended for children under 12 years of age.

Overdose.

Symptoms: nausea, vomiting, diarrhea, constipation, gastrointestinal disturbances, sleep disorders, increased nervous system excitability.

Treatment: In case of overdose, symptomatic therapy, gastric lavage, and enterosorbents are indicated.

Side effects.

Gastrointestinal tract: gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain.

Immune system: hypersensitivity reactions, including skin rash, pruritus, urticaria, angioedema, hyperemia; dyspnea, dizziness, sudden drop in blood pressure, Stevens-Johnson syndrome, anaphylactic shock.

Respiratory system: breathing difficulties, dyspnea, bronchospasm with obstruction, bronchial asthma (may occur as part of a hypersensitivity reaction).

Blood and lymphatic system: leukopenia — with prolonged use of the drug (more than 8 weeks).

Other: excitation, sleep disturbances.

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).

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 carton.

Availability category. Over-the-counter.

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua