Ismigen^® (Tablets) Instructions for Use

Marketing Authorization Holder

Lallemand Pharma, AG (Switzerland)

ATC Code

L03AX (Other immunostimulants)

Dosage Form

Ismigen®

Sublingual tablets 7 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Sublingual tablets light cream in color with brown specks, flat-cylindrical, with a score line, with a faint mint odor.

Excipients: glycine, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, colloidal silicon dioxide, magnesium stearate, ammonium glycyrrhizinate, mint flavor.

10 pcs. – blister packs (1) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Ismigen^® is a combined immunostimulating drug of bacterial origin for sublingual administration. It is a polyvalent antigenic complex, including lysates of bacteria – the most common pathogens of respiratory infections. The lysates included in the composition of the drug Ismigen^® are obtained by mechanical destruction of bacterial cells. Ismigen^® has a non-specific immunostimulating and specific vaccinating action.

Ismigen^® sublingual tablets act on various parts of the immune system. It stimulates both local (increases the concentration of secretory IgA) and systemic (cellular and humoral) immunity. It activates phagocytosis, increases the lysozyme content in saliva, promotes an increase in the number of immunocompetent cells, increases the concentration of serum IgA, IgG, IgM and decreases the concentration of serum IgE.

It increases the functional activity of macrophages (including alveolar) and polymorphonuclear leukocytes, which contributes to the destruction of infectious agents.

As a result of treatment with the drug Ismigen^®, the frequency, severity and duration of acute respiratory tract infections are reduced; alleviation and leveling of symptoms such as fever, cough, shortness of breath is observed; the need for antibacterial and anti-inflammatory therapy is reduced; in patients with chronic respiratory tract diseases, the drug also prevents exacerbations.

Indications

Acute and subacute infections of the upper and lower respiratory tract, including complications after influenza (treatment as part of combination therapy)

• Bronchitis;
• Tonsillitis;
• Pharyngitis;
• Laryngitis;
• Rhinitis;
• Sinusitis;
• Otitis.

Recurrent infections of the upper and lower respiratory tract, chronic bronchitis (prevention of exacerbations).

ICD codes

Dosage Regimen

Sublingually; take on an empty stomach. The tablet should be held under the tongue until completely dissolved. Sublingual tablets should not be sucked, chewed, or swallowed.

Acute and subacute infections of the upper and lower respiratory tract

1 tablet/day until the symptoms of the disease disappear (for at least 10 days).

Recurrent infections of the upper and lower respiratory tract, prevention of exacerbations of chronic respiratory diseases

1 tablet/day for 10 days. The prophylactic course includes three cycles of 10 days each with 20-day intervals between them.

The prophylactic course should be carried out no more than 1-2 times a year.

If a dose is missed, the next dose should not be doubled.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, the patient should consult a doctor.

Adverse Reactions

The frequency of adverse effects is classified according to WHO recommendations: very common (more than 10%); common (more than 1% and less than 10%); uncommon (more than 0.1% and less than 1%); rare (more than 0.01% and less than 0.1%); very rare (less than 0.01%), frequency unknown (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders: very rare – urticaria, dermatitis, folliculitis; frequency unknown – allergic reactions, such as rash, itching and angioedema.

Other: very rare – inflammation of the salivary gland, acute laryngitis, rhinitis.

If the above adverse effects are noted or worsen, or other adverse effects occur, the patient should inform the doctor.

Contraindications

• Hypersensitivity to the active and/or excipients of the drug;
• Autoimmune diseases;
• Pregnancy;
• Breastfeeding period;
• Children under 3 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Children aged 3 to 6 years, during daily administration, until the tablet is completely dissolved in the oral cavity, should be under adult supervision.

Special Precautions

Children aged 3 to 6 years, during daily administration, until the tablet is completely dissolved in the oral cavity, should be under adult supervision.

Effect on the ability to drive vehicles and mechanisms

Does not affect the ability to drive vehicles, mechanisms and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported.

Drug Interactions

Ismigen^® can be used simultaneously with other drugs intended for the treatment of acute and chronic respiratory diseases.

Features of the interaction of the drug Ismigen^® with other drugs have not been described to date.

If the patient is taking the above or other drugs (including over-the-counter), they should consult a doctor.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.