Imuno-ton®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMUNO-TON® (IMMUNO-TON)

Composition:

Active substances:

5 ml of syrup contains liquid extract of Eleutherococcus (extractum eleutherococcii fluidum) (extraction solvent – 40% v/v ethanol) (1:1) – 0.98 g, tincture of purple coneflower (Echinacea purpurea) (extraction solvent – 50% v/v ethanol) (1:10) – 0.47 g, tincture of St. John's wort (tinctura hyperici) (extraction solvent – 40% v/v ethanol) (1:5) – 0.49 g;

Excipient: sugar syrup.

Pharmaceutical form. Syrup.

Main physicochemical properties: yellowish-brown to reddish-brown liquid. Sediment may be present after storage.

Pharmacotherapeutic group. Immunostimulants.

ATC code L03AX.

Pharmacological Properties.

Pharmacodynamics.

Imuno-Ton® exhibits a combined adaptogenic and immunostimulatory effect, which is determined by the properties of biologically active substances from echinacea, eleuthero, and St. John's wort. Imuno-Ton® stimulates the immune system and exerts a mild tonic effect on the central nervous system. Imuno-Ton® has pronounced radioprotective, stress-protective, antidepressant, anti-inflammatory, and actoprotective (antioxidant and anti-hypoxic) effects.

Imuno-Ton® optimizes energy expenditures of the carbohydrate-phosphorus metabolism in tissues (increases carbohydrate synthesis, while fat synthesis is inhibited and their utilization is enhanced) and increases protein synthesis. The immunomodulatory effect is due to stimulation primarily of cellular immunity, an increase in the number of T-lymphocytes, enhancement of leukocyte phagocytic activity, and release of certain cytokines.

Clinical characteristics.

Indications.

As part of complex therapy:

• Asthenic and immunodeficient states in chronic recurrent inflammatory diseases, postoperative period, after antibiotic therapy, cytostatic, immunosuppressive, or radiation therapy;
• High physical and mental loads; physical and psychoemotional fatigue.
• Increasing resistance to adverse environmental factors (including cold exposure), prevention of colds and influenza.

Contraindications.

• Hypersensitivity to the components of the drug, allergy to plants of the Asteraceae family (chamomile, arnica, calendula, yarrow).
• Progressive systemic diseases (tuberculosis; diabetes mellitus; sarcoidosis).
• Disorders of the leukocyte blood system (including leukemia, agranulocytosis).
• Autoimmune diseases; collagenosis; rheumatism; systemic lupus erythematosus; multiple sclerosis.
• Acute phase of infectious and somatic diseases; chronic viral diseases; HIV infection, AIDS; primary immunodeficiency; febrile conditions.
• Arterial hypertension; cardiac arrhythmia; increased excitability; epilepsy; insomnia; myocardial infarction; neurocirculatory dystonia; oncological diseases.

Interaction with other medicinal products and other types of interactions.

Imuno-ton® reduces sedative effects and central nervous system depression caused by chloral hydrate, barbiturates, and chlorpromazine, and diminishes some effects of adrenaline and sodium salicylate.

The drug may potentiate the effects of alcohol, psychostimulants, analeptics, central nervous system stimulants, hypoglycemic agents, and centrally-acting antihypertensive drugs.

Concomitant use with immunosuppressants is not recommended due to reduced efficacy, as well as in patients scheduled for organ transplantation who require immunosuppressive therapy.

When used concomitantly with antidepressants, there is a risk of developing adverse effects.

The drug should not be administered simultaneously with protease inhibitors, nucleoside reverse transcriptase inhibitors, indirect anticoagulants, cyclosporine, oral contraceptives, cardiac glycosides (digoxin), hypocholesterolemic agents, antibiotics, sulfonamides, theophylline, anticonvulsants, serotonin reuptake inhibitors, sumatriptan, or corticosteroids.

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

Special precautions for use.

During the period of using Imuno-ton® medication, patients should avoid prolonged exposure to sunlight and refrain from visiting solariums due to the risk of developing skin reactions associated with photosensitization.

If surgical procedures are necessary, the medication should be discontinued at least 5 days prior to surgery.

The product contains sugar syrup; therefore, diabetic patients should consult their physician before using this medication.

Due to the possibility of allergic reactions, Imuno-ton® should be used with caution in patients with bronchial asthma, atopic dermatitis, allergic rhinitis, as well as in patients with liver dysfunction.

When the medication is taken in the second half of the day, insomnia may occur. Therefore, individuals who experience this effect should not take the medication in the evening.

Arterial pressure should be monitored during treatment with this medication.

Use during pregnancy or breastfeeding.

The use of this medication during pregnancy is contraindicated. The medication should not be administered during breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

Patients should refrain from driving vehicles and from activities requiring high attention and rapid psychomotor reactions.

Dosage and Administration

Shake well before use.

For adults and children aged 12 years and older: 2–3 teaspoons (10–15 mL) twice daily (in the first half of the day, after meals). The syrup may be taken together with tea, milk, or other beverages. Treatment duration: 7–10 days.

For prevention of colds and influenza, Imuno-ton® is administered at 1 teaspoon (5 mL) twice daily (in the first half of the day, after meals) for 5–7 days.

Children. The product is contraindicated for children under 12 years of age.

Overdose.

Gastrointestinal disturbances, bitter taste in the mouth, discomfort in the liver area, nausea, vomiting, sleep disturbances, insomnia, hyperglycemia, increased excitability, elevated blood pressure, cardiac arrhythmia, reduced work capacity, hyperglycemia, allergic skin reactions. In case of pronounced symptoms, gastric lavage should be performed and antihistamine agents administered.

Side effects.

Imuno-Ton® is generally well tolerated. Echinacea purpurea, an ingredient of the medicinal product, may cause hypersensitivity reactions such as labored breathing, bronchospasm with obstruction, bronchial asthma, anaphylactic shock, Stevens-Johnson syndrome, angioneurotic edema, dizziness or hypotension, nausea, vomiting, diarrhea, abdominal pain. Isolated reports have linked its use to autoimmune disorders. The following adverse reactions may occur during use of the drug:

• Gastrointestinal disorders: dyspeptic symptoms;
• Immune system disorders: allergic reactions (including skin rash, pruritus, edema, hyperemia, urticaria, chills, skin reactions associated with photosensitization);
• Cardiovascular system disorders: increased arterial pressure, cardiac arrhythmia, tachycardia;
• Central and peripheral nervous system disorders: headache, sleep disturbances, insomnia, irritability, increased nervous excitability, anxiety, decreased work capacity;
• Other: hypersalivation.

With prolonged use (more than 8 weeks), suppression of immune system function (leukopenia), muscle spasms, and gastrointestinal disturbances may develop.

If any adverse reactions occur, discontinue use of the drug and consult a physician.

Shelf life. 2 years.

Storage conditions.

In original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in a bottle or flask, or 200 ml in a flask; 1 bottle or flask per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Galichfarm".

Manufacturer's address and location of business activity.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.