Immunal®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMMUNAL® (IMMUNAL®)

Composition:

Active ingredient: 1 tablet contains 80 mg of dried juice obtained from freshly harvested flowering purple coneflower herb (Echinacea purpurea L.), (31-60:1);

Excipients: lactose monohydrate, magnesium stearate, sodium saccharin, colloidal anhydrous silicon dioxide, vanillin, cherry flavoring.

Medicinal form. Tablets.

Main physicochemical characteristics: round, flat on both sides, light-brown tablets with specks.

Pharmacotherapeutic group.

Immunostimulants. ATC code L03A X.

Pharmacological properties.

Pharmacodynamics.

Imunal® is a herbal medicinal product. The tablets contain juice obtained from freshly harvested flowering parts of the purple coneflower plant (Echinacea purpurea). Echinacea contains biologically active substances that stimulate the non-specific immune system, enhancing the body's defense mechanisms. The main active ingredients of Echinacea purpurea are derivatives of caffeic acid (such as chicoric acid and its esters), alkylamides, and polysaccharides, which possess immunostimulatory activity. Non-specific immune stimulation is primarily manifested by increased phagocytic activity of granulocytes and macrophages. There is also an enhanced release of cytokines, which stimulate other cells of the immune system. Antiviral activity of Echinacea purpurea against influenza and herpes viruses has also been demonstrated.

Due to the immunostimulatory activity of Echinacea purpurea in humans, resistance to respiratory tract infections is increased.

Clinical characteristics.

Indications.

Short-term prophylaxis and treatment of colds.

Contraindications.

• Hypersensitivity to echinacea, other plants of the Asteraceae family (chamomile, arnica, calendula, yarrow) or to any other component of the medicinal product.
• Progressive systemic diseases (e.g., tuberculosis, sarcoidosis); autoimmune disorders (e.g., collagenoses, multiple sclerosis); immunodeficiency states (e.g., HIV infection, AIDS); immunosuppression (e.g., cytostatic therapy for oncological diseases, history of organ or bone marrow transplantation); blood disorders (e.g., agranulocytosis, leukemia).
• Patients with hereditary predisposition to allergic reactions (e.g., urticaria, atopic dermatitis, bronchial asthma).

Interaction with other medicinal products and other types of interactions.

Interaction with other medicinal products is unknown. Concomitant use of Imunal® with immunosuppressive agents (e.g., cyclosporine, methotrexate) is not recommended.

Special precautions for use.

Do not exceed recommended doses.

The medicine is not recommended for children under 4 years of age. Experience with the use of the medicine in children aged 4 to 12 years is limited; therefore, consultation with a physician is recommended prior to administration.

If symptoms persist for more than 10 days, worsen, or if body temperature increases during treatment, seek immediate medical advice. In case of frequent relapses of respiratory diseases and prolonged symptoms such as difficulty breathing, fever, or presence of purulent or bloody sputum, it is essential to consult a physician.

Patients with atopic disorders or with a hereditary predisposition to allergy are at risk of developing anaphylactic reactions. Such patients should consult their physician before starting treatment with Imunal®.

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

Use during pregnancy or breastfeeding.

Experience with the use of the medicine during pregnancy or breastfeeding is limited; therefore, Imunal® should not be used during these periods except under specific medical advice.

Limited data (several hundred pregnant women) suggest no adverse effects of echinacea on pregnancy or on fetal/neonatal health. Data regarding the newborn's immune system are lacking. To date, no other relevant epidemiological studies have been conducted, and data on the effect of Imunal® on fertility are not available.

Ability to influence reaction rate while driving or operating machinery.

Specific studies on the effect of echinacea on the ability to drive or operate machinery have not been conducted. However, dizziness may occur during treatment, which should be taken into account when driving or operating machinery.

Dosage and Administration.

Children aged 4 to 6 years: 1 tablet twice daily after consultation with a physician.

Children aged 6 to 12 years: 1 tablet three times daily after consultation with a physician.

Adults, including elderly patients, and children aged 12 years and older: 1 tablet 3–4 times daily.

The tablets should be taken independently of food intake, with a sufficient amount of water (1 glass).

For prophylaxis and treatment, the drug should not be used for more than 10 days. Repeated use of the drug is possible no sooner than after 14 days.

Treatment should be initiated at the first signs of illness.

Consult a physician if symptoms of illness do not resolve within 10 days or longer.

Children.

The drug is indicated for children aged 4 years and older.

Overdose.

Cases of overdose have not been reported. A more pronounced manifestation of adverse effects is possible.

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

In case of overdose, symptomatic therapy, gastric lavage, and enteral sorbents are recommended.

Adverse reactions.

The frequency of adverse reactions cannot be determined from the available data. The adverse reactions listed below may occur in individual cases.

Immune system disorders: hypersensitivity reactions (e.g., itching, skin rashes, skin hyperemia, facial swelling); Stevens-Johnson syndrome; angioneurotic skin edema; Quincke's edema; anaphylactic shock. Medicinal products containing echinacea may cause allergic reactions in patients with hereditary predisposition to allergies.

There have been isolated reports of effects on the course of autoimmune diseases (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans' syndrome, and Sjögren's syndrome with impaired renal tubular function).

Dizziness, arterial hypotension, nausea, vomiting, and diarrhea may occur infrequently.

Respiratory, thoracic and mediastinal disorders: bronchospasm with obstruction and bronchial asthma may occur in the context of hypersensitivity reactions.

Blood and lymphatic system disorders: leukopenia may occur with prolonged use (more than 8 weeks).

Gastrointestinal disorders: gastrointestinal disturbances have been reported, including nausea, vomiting, diarrhea, and abdominal pain.

Nervous system disorders: reports of excitation and sleep disturbances have been received.

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister; 2 blisters (10 × 2) per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Lek Pharmaceuticals d. d. (batch release).

Manufacturer's address and place of business.

Verovškova 57, 1526 Ljubljana, Slovenia.