Immunophytol^® (Syrup) Instructions for Use

Marketing Authorization Holder

Krasnogorskleksredstva, JSC (Russia)

Manufactured By

Phytopharm Kleka, S.A. (Poland)

ATC Code

L03AX (Other immunostimulants)

Active Substances

Ascorbic acid (Rec.INN WHO registered)

Aloe (USP United States Pharmacopeia)

Dosage Form

Immunophytol®

Syrup: 100 ml bottle with a measuring spoon

Dosage Form, Packaging, and Composition

Syrup is a brownish-red liquid with a characteristic odor; the formation of a small sediment is possible during storage.

Excipients: sucrose, concentrated chokeberry juice**, sodium benzoate, purified water.

100 ml – dark glass bottles (1) complete with a measuring spoon – cardboard boxes.

* The aqueous extract from fresh leaves of Aloe arborescens is prepared from fresh leaves of Aloe arborescens (Aloe arborescens Mill., family Asphodelaceae); extractant: water for the preparation of extracts.
** The concentrated chokeberry juice is prepared from the fruits of chokeberry (Aronia melanocarpa (Minch.) Elliot., family Rosaceae).

Clinical-Pharmacological Group

Herbal immunostimulant drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

It is an immunostimulating agent of plant origin, the action of which is determined by the properties of its constituent components.

The active substances contained in the extract from the leaves of Aloe arborescens have a stimulating effect on both humoral and cellular immunity: they cause an increase in the number of T- and B-lymphocytes, as well as the number of antibodies circulating in the blood, stimulate the chemokinetic activity of cells, and stimulate phagocytosis, which leads to an increase in the body’s resistance to bacterial and viral infections.

The agent has an anti-inflammatory effect (inhibits the formation and release of inflammation markers interleukin-6, TNF-α, interleukin-1β, histamine, eicosanoids).

In addition, it has antibacterial and antiviral effects and helps to increase appetite.

Indications

Complex therapy of viral and bacterial infections of the upper respiratory tract (acute and chronic pharyngitis, chronic tonsillitis, tonsillitis, acute or recurrent rhinitis, laryngitis, laryngotracheitis, sinusitis) in children from 3 years of age and adults.

Prevention of recurrences of viral and bacterial infections of the upper respiratory tract in children from 3 years of age and adults.

ICD codes

Dosage Regimen

Administer orally. Shake the bottle well before each use. Use only the provided measuring spoon for accurate dosing.

For adults and adolescents over 12 years of age, take 10 ml (two 5 ml measuring spoons) two to three times daily.

For children aged 6 to 12 years, take 5 ml (one measuring spoon) two to three times daily.

For children aged 3 to 6 years, take 2.5 ml (one-half of a measuring spoon) two to three times daily.

Take doses during or immediately after a meal to minimize potential gastrointestinal discomfort.

The standard treatment course is 14 days (2 weeks). Do not exceed the recommended duration without medical supervision.

For preventive use, follow the same age-specific dosage, but limit the course to 14 days. Maintain an interval of at least 2 weeks before initiating any subsequent preventive course.

Consult a physician regarding the need for repeated courses or an extended treatment duration. Discontinue use and seek medical advice if any adverse reactions occur.

Adverse Reactions

Possible allergic reactions, dyspeptic symptoms.

Contraindications

Hypersensitivity to the components of the agent; simultaneous use with immunosuppressive drugs; pregnancy, breastfeeding period; children under 3 years of age.

With caution

In case of a tendency to allergies, systemic and autoimmune diseases (generalized scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves’ disease, multiple sclerosis, insulin-dependent diabetes, rheumatoid arthritis), elevated concentrations of immunoglobulins in the blood.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

Increasing the duration and conducting repeated courses of treatment is possible on the recommendation of a doctor. A 2-week break should be taken between repeated courses.

Given the mechanism of action, the agent should not be taken immediately after vaccinations; a break of at least 2 weeks should be taken.

The agent should not be taken during chemotherapy.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.