Tonsilgon^® N (Tablets, Drops) Instructions for Use

ATC Code

R02AX (Other drugs for the treatment of throat diseases)

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; other drugs for the treatment of throat diseases

Pharmacological Action

Mechanism of action and pharmacodynamic properties

Tonsilgon^® N has anti-inflammatory, antiseptic, immunomodulatory, and antioxidant effects.

The results of experimental studies have shown that the hydroalcoholic extract of Tonsilgon^® N has an immunomodulatory effect by increasing the percentage of phagocytic cells and natural killer (NK) cells.

The anti-inflammatory and antioxidant activity of the hydroalcoholic extract of Tonsilgon^® N has been demonstrated in in vitro and in vivo studies.

The antibacterial and antiviral effects of the hydroalcoholic extract of Tonsilgon^® N have also been demonstrated in vitro against S. pneumoniae and respiratory syncytial virus (RSV), i.e., against bacterial and viral strains that cause respiratory tract infections.

Preclinical safety data

In preclinical data obtained from standard genotoxicity studies, no specific harm to humans was identified. Studies on reproductive toxicity and carcinogenicity have not been conducted.

Indications

For adults and children from 6 to 18 years of age with

• Acute and chronic diseases of the upper respiratory tract (tonsillitis, pharyngitis, laryngitis);
• Prevention of complications in respiratory viral infections and as an adjunct to antibiotic therapy for bacterial infections.

ICD codes

Dosage Regimen

Drops

The drug is taken orally.

The oral drops are taken undiluted, held in the mouth for some time before swallowing.

Unless the doctor has prescribed a different dosage regimen, the following dosage regimens should be followed.

During the acute period of the diseasefor adults and children over 12 years old – 25 drops 5-6 times/day, for children from 6 to 12 years old – 15 drops 5-6 times/day, for children from 1 year to 6 years old– 10 drops 5-6 times/day.

After the acute symptoms of the disease disappear (sore throat), treatment with the drug should be continued for another 1 week: for adults and children over 12 years old– 25 drops 3 times/day, for children from 6 to 12 years old – 15 drops 3 times/day, for children from 1 year to 6 years old– 10 drops 3 times/day.

If during the use of the drug the symptoms of the disease persist without improvement for 7 days, it is necessary to consult a doctor.

If complaints recur after completion of the course of treatment with the drug, it is necessary to consult a doctor.

The drug should be used only according to the indications, method of application, and doses specified in the instructions.

Tablets

The drug is taken orally.

The tablets are swallowed whole, without chewing, with a sufficient amount of water (e.g., 1 glass).

The duration of treatment depends on the course of the disease.

After the disappearance of the acute symptoms of the disease (sore throat), treatment with the drug should be continued for another 1 week.

Increasing the duration and conducting repeated courses of treatment is possible on the recommendation of a doctor.

Children

Safety and efficacy in children aged 0 to 6 years have not been established to date. Data are not available.

Adverse Reactions

When assessing the frequency of adverse reactions, the following categories were used as a basis: very common (≥1/10), common (≥1/100 but <1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

From the immune system rare – allergic reactions (skin rash, skin redness, itching).

From the gastrointestinal tract rare – gastrointestinal disorders (abdominal pain, nausea, vomiting).

The patient must be informed that at the first signs of an allergic reaction, the drug should be discontinued and a doctor should be consulted; that if side effects listed in the instructions appear or worsen, or any other side effects not listed in the instructions appear, it is necessary to consult a doctor.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to the active components of the drug, as well as to other plants of the Asteraceae family, for example, wormwood, yarrow, chrysanthemum, daisy, or to any of the excipients included in the drug.

Use in Pregnancy and Lactation

Pregnancy

There are insufficient data on the use of the drug in pregnant women. Animal reproductive toxicity studies have not been conducted (see the “Preclinical safety data” subsection). Use of the drug is possible if the potential benefit to the mother outweighs the potential risk to the fetus, consultation with a doctor is necessary.

Breastfeeding period

It is unknown whether the active components of Tonsilgon^® or their metabolites are excreted into breast milk. Use of the drug is possible if the potential benefit to the mother outweighs the potential risk to the child, consultation with a doctor is necessary.

Fertility

There are no data on the effect of Tonsilgon^® on fertility in humans.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

If the symptoms of the disease persist for more than 7 days, recur periodically, new symptoms appear, or the patient’s condition worsens (shortness of breath, fever, pus and/or blood in the sputum occur), it is necessary to consult a doctor.

Excipients

Patients with rare hereditary fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take Tonsilgon^® N (the drug contains lactose, glucose, sucrose).

Information for patients with diabetes mellitus: the content of digestible carbohydrates in one coated tablet corresponds to 0.03 XE (Bread Units).

Effect on ability to drive vehicles and operate machinery

The use of Tonsilgon^® does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery, work of a dispatcher, operator).

Overdose

To date, no cases of overdose have been reported.

Symptoms possible increase in the severity of dose-dependent adverse reactions.

Treatment symptomatic.

Drug Interactions

Combination with antibacterial drugs is possible and appropriate.

Interaction studies have not been conducted. There are no reports of clinical interaction of Tonsilgon^® with other drugs.

Storage Conditions

No special storage conditions are required for this medicinal product.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed 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.