Tonsifitt (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Pharm-Pro, LLC (Russia)

Dosage Form

Tonsifitt

Tablets: 24 pcs.

Dosage Form, Packaging, and Product Composition

Tablets weighing 600 mg.

Auxiliary substances : microcrystalline cellulose (carrier), maltodextrin (stabilizer), calcium stearate (anti-caking agent), silicon dioxide (anti-caking agent).

24 pcs. – blisters (1) – carton packs.

Therapeutic Category

Dietary supplement for normalization of the state of ENT organs, incl. for colds

Indications

• Tonsifitt is a dietary supplement indicated for use as an additional source of flavonoids derived from a complex of plant extracts.
• It is intended to help normalize the state of the upper respiratory tract and ENT organs (ear, nose, and throat).
• The supplement may be used to support overall throat and tonsil health, particularly during seasonal periods of heightened susceptibility to upper respiratory discomfort.
• It is formulated to be used as a supportive measure for the throat as part of a general wellness regimen.

Contraindications

• Individual hypersensitivity or an allergic reaction to any of the components of the dietary supplement, including the active plant extracts (walnut leaves, horsetail, marshmallow, chamomile, yarrow, oak bark, dandelion) or any of the auxiliary substances.
• Pregnancy and the period of breastfeeding (lactation). The safety of the product for use during pregnancy and by nursing mothers has not been established, and therefore use is contraindicated.
• Children and adolescents under the age of 18 years. The efficacy and safety profile of Tonsifitt in this population group have not been studied.
• Patients with known severe renal or hepatic impairment should avoid use due to the lack of specific safety data in these conditions.

Dosage Regimen

The recommended dosage for adults and children over 18 years of age is one 600 mg tablet taken orally twice daily, preferably with meals.

The tablet should be swallowed whole with a sufficient amount of water (approximately half a glass); it is not intended to be chewed or crushed.

The duration of continuous use should not exceed four weeks. If symptoms persist or worsen, or if long-term use is desired, it is imperative to consult a healthcare professional for further evaluation and advice.

Do not exceed the recommended daily dose. The use of this product is not a substitute for a varied and balanced diet and a healthy lifestyle.

Adverse Reactions

Tonsifitt is generally well-tolerated when used at the recommended dosage. However, as with any biologically active substance, there is a potential for adverse reactions.

The most commonly reported adverse reactions are mild gastrointestinal disturbances, which may include symptoms such as nausea, abdominal discomfort, or a feeling of fullness. These effects are typically transient and resolve without intervention.

Due to the presence of multiple plant-derived components, there is a risk of allergic reactions. These can manifest as skin rash, pruritus (itching), urticaria (hives), or, in very rare cases, more severe systemic reactions. If any signs of an allergic reaction occur, discontinue use immediately and seek medical attention.

If any other undesirable effects not listed here are experienced, it is recommended to stop taking the supplement and consult a physician.

Drug Interactions

While specific interaction studies have not been conducted with Tonsifitt, the potential for interactions with concurrently administered medications should be considered due to its complex botanical composition.

Theoretically, the supplement could influence the pharmacokinetics (absorption, distribution, metabolism, and excretion) of certain prescription drugs. Particular caution is advised for patients taking medications with a narrow therapeutic index, such as warfarin, digoxin, or phenytoin, where minor changes in plasma concentration could lead to serious clinical consequences.

There is a possibility that components of the supplement may affect the activity of hepatic cytochrome P450 enzymes, potentially altering the metabolism of drugs that are substrates for these enzymes.

It is critically important to inform your healthcare provider about all the dietary supplements and over-the-counter medications you are taking before starting Tonsifitt, especially if you are on any long-term prescription therapy.

Overdose

Cases of overdose with Tonsifitt have not been reported. However, taking an amount significantly exceeding the recommended daily dose may increase the risk and severity of the adverse reactions described previously.

Symptoms of overdose would likely be an extension of the product’s known adverse effect profile, primarily involving gastrointestinal upset such as nausea, vomiting, or diarrhea.

In the event of a suspected overdose, discontinue the product immediately and drink plenty of fluids to maintain hydration. Treatment should be symptomatic and supportive. There is no specific antidote. If a large quantity has been ingested or if severe symptoms develop, seek immediate medical attention or contact a poison control center.

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.