Tonsilgon N Drops for oral administration, 100 ml bottle

Compound

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE TONSILON N TABLETS

1. Name of the drug

Tonsilgon® N

2. Qualitative and quantitative composition

1 tablet contains crushed medicinal plant raw materials (powder) from:

• Dandelion herbs (Taraxaci herba) 4 mg
• Horsetail herb (Equiseti herba) 10 mg
• Marshmallow root (Althaeae radix) 8 mg
• Chamomile flowers (Matricariae flores) 6 mg
• Oak bark (Quercus cortex) 4 mg
• Walnut leaves (Juglandis folia) 12 mg
• Yarrow herb (Millefolii herba) 4 mg

3. Dosage form

Film-coated tablets.

Description

Round, biconvex, light blue, film-coated tablets with a smooth surface.

4. Clinical data

4.1 Therapeutic indications

In the complex treatment of acute respiratory diseases, accompanied by sore and sore throat, difficulty swallowing, cough. Use for these purposes is based only on experience of long-term use.

4.2 Method of administration and dosage

Children under 6 years of age - the drug is contraindicated;

children aged 6 to 11 years - during the acute period of the disease, 1 tablet 5-6 times a day, after the severity of symptoms decreases, 1 tablet 3 times a day;

children over 12 years of age and adults - during the acute period of the disease, 2 tablets 5-6 times a day, after the severity of symptoms has decreased, 2 tablets 3 times a day.

Use in patients with impaired liver and/or kidney function: no information available.

Mode of application.

The tablet should be swallowed whole, without chewing, with a sufficient amount of water.

Duration of admission.

The drug is not recommended to be taken for more than 2 weeks.

4.3 Contraindications

Hypersensitivity to the components of the drug, to plants of the Asteraceae family.

4.4 Precautions

Patients with congenital galactose intolerance, fructose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase deficiency should not take this drug.

One film-coated tablet contains about 0.02 bread units (BE).

The drug is contraindicated in children under 6 years of age.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been conducted. At the moment, there is no information on interactions with other drugs.

With the simultaneous use of drugs containing oak bark, the absorption of alkaloids and other alkaline components may be reduced or blocked.

4.6 Use during pregnancy or breastfeeding

There are no or limited data on the use of the drug Tonsilgon N in pregnant women. The drug Tonzilgon N is not recommended for pregnant women.

There are no data on the presence of active substances or their metabolites in breast milk. A risk to breastfed children cannot be excluded. The drug Tonzilgon N is not recommended for women who are breastfeeding. There are no data on the effect on fertility.

4.7 Effect on the ability to drive a car or use machinery

The medicine does not affect the ability to drive a car or operate machinery.

4.8 Side effects

The frequency of possible side effects listed below is determined according to the following scale:

• very often (≥1/10),
• often (≥1/100 to <1/10),
• uncommon (≥1/1000 to <1/100),
• rarely (≥1/10000 to <1/1000),
• very rare (<1/10000),
• unknown (cannot be estimated from available data).

Rarely, gastrointestinal disorders (nausea, vomiting, diarrhea). Allergic reactions are possible (rash, urticaria, angioedema).

When using medicinal products containing chamomile flowers, hypersensitivity reactions may develop in persons with hypersensitivity to plants of the Asteraceae family (for example, wormwood, yarrow, chrysanthemum, daisy) due to so-called cross-reactions.

When the first signs of an allergic reaction appear, you should stop using the drug Tonzilgon® N.

If any adverse reactions occur, including those not listed in this instruction, you should stop using the drug and consult a doctor.

4.9. Overdose

No cases of overdose have been described.

If the drug is used in doses exceeding therapeutic doses, symptomatic treatment is necessary.

5. Pharmacological properties

Pharmacotherapeutic group

Other medicines used for colds.

ATC code R05X.

5.1 Pharmacological action

The medicine contains components of plant origin as active ingredients. Use for these purposes is based on experience of long-term use.

5.2 Pharmacokinetic properties

No data available.

5.3 Non-clinical safety data

Preclinical studies are incomplete. Safety data are based on experience with long-term use. Reproduction and carcinogenicity studies have not been performed.

In a test for assessing bacterial reverse mutations using Salmonella typhimurium, carried out with the active ingredients of the drug Tonsilgon N, the mutagenic potential of this combination of substances was not revealed.

6. Pharmaceutical data

6.1 List of excipients

Lactose monohydrate, corn starch, potato starch, stearic acid, glucose monohydrate, colloidal silicon dioxide anhydrous, calcium carbonate, castor oil, dextrin, glucose syrup, indigotin (E 132), montane glycol wax, povidone K 25, povidone K 30, sucrose , shellac, talc, titanium dioxide (E 171)

6.2 Storage conditions and shelf life

4 years. Do not use after the expiration date stated on the package. Store at a temperature not exceeding 30 °C. Keep out of the reach of children.

6.4 Packaging

25 tablets per blister. 2 or 4 blisters along with instructions for use in a cardboard box.

6.5 Holiday conditions

Without a doctor's prescription.

7. Marketing authorization holder

BIONORICA SE

Kerschensteinerstrasse 11-15,

92318 Neumarkt, Germany.

Pharmacodynamics

Pharmacological properties are determined by the biologically active substances that make up the drug. Tonsilgon® N has anti-inflammatory and antiseptic effects. The active components of chamomile, marshmallow and horsetail included in the preparation help increase the activity of nonspecific body defense factors. Polysaccharides, essential oils and flavonoids of chamomile, marshmallow and yarrow, oak bark tannins have an anti-inflammatory effect and help reduce swelling of the mucous membrane of the respiratory tract.

Contraindications

hypersensitivity to the components of the drug, incl. plants of the Asteraceae family;

intolerance to lactose, fructose, deficiency of lactase, sucrase-isomaltase, glucose-galactose malabsorption (for pills);

children's age (for drops - up to 1 year, for pills - up to 6 years);

alcoholism, incl. after anti-alcohol treatment (for drops).

With caution (for drops): liver diseases, head injury, brain diseases, children over 1 year of age (use is possible only after consultation with a doctor due to the ethyl alcohol content in the drug).

Directions for use and doses

Inside.

Dragee. Swallow whole without chewing, wash down with water if necessary.

During the acute period of the disease: adults - 2 tablets 5-6 times a day; school-age children (over 6 years old) - 1 tablet 5-6 times a day.

After the acute symptoms of the disease (sore throat) disappear, treatment with the drug should be continued for another 1 week: adults - 2 tablets 3 times a day; school-age children (over 6 years old) - 1 tablet 3 times a day.

Drops. Take undiluted, keeping it in your mouth for a while before swallowing.

During the acute period of disease development: adults - 25 drops 5-6 times a day; school-age children (over 6 years old) - 15 drops 5-6 times a day; children of preschool age (over 1 year) - 10 drops 5-6 times a day.

After the acute symptoms of the disease (sore throat) disappear, treatment with the drug should be continued for another 1 week: adults - 25 drops 3 times a day; school-age children (over 6 years old) - 15 drops 3 times a day; preschool age (over 1 year) - 10 drops 3 times a day.

Dosages from the instructions for Tonsilgon

The instructions for use of the drug contain the following recommendations for use:

• adults – 2 tablets or 25 drops up to 6 times a day;
• up to the first year of life – 5 drops, procedures are carried out with a break of 4 hours;
• 1-6 years – 10 drops every four hours;
• 6-12 years – 1 tablet or 15 drops up to 6 procedures per day.

After completion of the acute phase of the disease, the frequency of taking the drug is reduced, the dosage remains at the same positions. The maximum number of procedures does not exceed 3 per day, maintenance therapy is carried out no more than one week.

The drops are used in their original form and are not diluted with water. Before swallowing, the solution is kept in the mouth for some time. Dragees cannot be crushed or chewed; they are consumed whole, washed down with a sufficient volume of liquid.

special instructions

If, after using the drug for 7 days, the symptoms of the disease persist or the patient’s condition worsens, you should consult a doctor.

One dragee contains less than 0.03 XE.

The content of ethyl alcohol in the preparation (drops) ranges from 16 to 19.5% by volume. In the maximum single dose (25 drops), the content of absolute ethyl alcohol is 0.21 g; in the maximum daily dose (25 drops 6 times a day) - 1.26 g.

During storage of the drug in the form of drops, slight turbidity or slight precipitation may occur, which does not affect the effectiveness of the drug. The drug should be shaken before use! When using the bottle, hold it with the drip device facing down in a vertical position.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions

Dragee. The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drops. During the period of use of the drug, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, due to the ethyl alcohol content in it.

Indications and contraindications for Tonsilgon therapy

The drug is used in the treatment of children and adults. Recommended for use:

• patients with insufficient level of resistance to infectious pathologies;
• for the treatment of acute and chronic pathologies affecting the upper respiratory tract, including tonsillitis, laryngitis, pharyngitis, rhinitis;
• for the treatment of respiratory diseases of infectious etiology;
• preventing the development of chronic pathologies of the upper respiratory tract.

Tonsilgon is not used if certain indicators are present:

• in case of individual intolerance to the component composition;
• allergic reactions to treatment with herbal remedies recorded in the medical history.

Particular care during therapy and observation by medical personnel is necessary for patients with liver dysfunction. The medication in drops is not recommended for patients with alcohol dependence or after undergoing a course of therapy associated with it.

If the medicine is prescribed in the form of pills, then increased caution is needed for patients with congenital lactose intolerance or diabetes mellitus. The medicine contains more than 0.03 bread units of digestible carbohydrates.

Therapy for pregnant and lactating women is carried out only with the approval of the attending physician. During these periods, preference is given to Tonsilgon tablets; the drug is not prescribed in the first three months of gestation. When breastfeeding and parallel treatment, the child is transferred to artificial nutrition for the entire period.