Tonsipret^® (Tablets) Instructions for Use

Marketing Authorization Holder

Bionorica, SE (Germany)

Manufactured By

Rottendorf Pharma, GmbH (Germany)

Packaging and Quality Control Release

BIONORICA, SE (Germany)

Contact Information

BIONORICA LLC (Russia)

ATC Code

V30 (Not assigned)

Dosage Form

Tonsipret®

Homeopathic sublingual tablets: 25, 50, 100 or 200 pcs.

Dosage Form, Packaging, and Composition

Homeopathic sublingual tablets white with a yellowish tint, round, flat-cylindrical, with a score on one side and a bevel on both sides. The break line (score) is not intended for breaking the tablet.

Excipients: potato starch, lactose monohydrate, magnesium stearate.

25 pcs. – blisters (1) – cardboard packs.
25 pcs. – blisters (2) – cardboard packs.
25 pcs. – blisters (4) – cardboard packs.
25 pcs. – blisters (8) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation used for diseases of the oral cavity and pharynx

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

A complex homeopathic preparation, the action of which is due to the components included in its composition.

Pharmacokinetics

Not applicable.

Indications

For use in adults

• As part of complex therapy as a symptomatic agent for sore throat in acute inflammatory diseases of the throat.

ICD codes

Dosage Regimen

The tablet should be held in the mouth until completely dissolved.

Recommended dose: in the acute period of the disease (with severe sore throat)– 1 tablet every 30-60 minutes, but no more than 6 times/day. When the sore throat decreases, the frequency of administration should be reduced and 1 tablet should be taken 1-3 times/day. The course of treatment is 7-10 days.

Safety and efficacy in children aged 0 to 18 years have not been established to date. Data are not available.

Adverse Reactions

When assessing the frequency of adverse reactions, the following categories were taken 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), unknown (cannot be estimated from the available data).

Gastrointestinal disorders: unknown – gastrointestinal disorders such as nausea.

Immune system disorders: unknown – allergic reactions.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients included in the preparation;
• Children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Tonsipret^® should not be taken during pregnancy and breastfeeding.

Fertility

Data on the effect of Tonsipret^® on fertility are not available.

Pediatric Use

The use of the drug is contraindicated in children and adolescents under 18 years of age.

Special Precautions

If the symptoms of the disease persist for more than 7-10 days, worsen or recur periodically, as well as in the presence of elevated body temperature for more than 3 days or when body temperature rises above 39°C (102.2°F), it is necessary to consult a doctor.

Excipients Tonsipret^® should not be taken by patients with rare hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Information for patients with diabetes the carbohydrate content in one tablet of the drug corresponds to 0.02 XE.

When using homeopathic medicinal products, a temporary exacerbation of existing symptoms (primary exacerbation) is possible. In this case, you should stop taking the drug and consult a doctor.

Effect on the ability to drive vehicles and mechanisms

When taken in recommended doses, Tonsipret^® does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

To date, no cases of overdose with the drug have been reported.

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

Treatment symptomatic.

Drug Interactions

Interaction studies have not been conducted.

The prescription of complex homeopathic preparations does not exclude the use of other medicinal products used for this disease.

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 printed on the package.

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.