Faritol S (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Faritol S

Lozenges: 25 pcs.

Dosage Form, Packaging, and Product Composition

Tablets for resorption with a mass of 350 mg.

Auxiliary substances : sorbitol (E420i), gum arabic (E414), silicon dioxide amorphous (E551), stearic acid (E570), natural grapefruit flavor (gum arabic (E414), maltodextrin, sugar, butylated hydroxyanisole (E320)).

25 pcs. – blisters (1) – packs cardboard.

Therapeutic Category

Dietary supplement, used for cough

Indications

• As a dietary supplement to the diet, it is a source of flavonoids and vitamin C.
• Used as a supportive measure to help soothe the throat and relieve irritation in the oropharynx associated with a dry cough.
• May be used to provide a soothing effect on the mucous membrane of the upper respiratory tract.

The product is intended for use as part of a complex approach to maintaining the health of the respiratory system and is not a standalone medicinal treatment for underlying conditions.

Contraindications

• Hypersensitivity or individual intolerance to any of the components of the dietary supplement, including the active ingredients (Glycyrrhiza root extract, Thyme leaf extract, Ascorbic acid) or any of the auxiliary substances.
• Pregnancy and breastfeeding – due to the lack of sufficient clinical data on safety during these periods, the use of the product is not recommended.
• Severe arterial hypertension – Glycyrrhiza root extract may influence electrolyte balance and fluid retention, which can exacerbate hypertension.
• Severe renal or hepatic impairment – caution is advised, and consultation with a healthcare professional is necessary before use in individuals with pre-existing conditions affecting these organs.
• Hypokalemia (low potassium levels) – Glycyrrhiza can potentially lower serum potassium levels, which may worsen this condition.

It is important to consult with a physician or qualified healthcare provider before starting use if you have any chronic diseases or are taking other medications to ensure there are no contraindications specific to your health status.

Dosage Regimen

The recommended dosage for adults and children over 14 years of age is one lozenge to be dissolved slowly in the mouth.

The tablet should be allowed to dissolve completely and should not be chewed or swallowed whole to achieve the intended local soothing effect in the oropharynx.

The dosage can be repeated up to 3-4 times per day, or as needed, depending on the level of throat discomfort. It is not recommended to exceed the stated daily frequency of use.

The duration of continuous use should not exceed one to two weeks without consulting a healthcare professional. If symptoms persist or worsen after several days of use, a doctor should be consulted for further evaluation.

The use of this product in children under 14 years of age is not recommended without explicit direction from a physician, as safety and efficacy in this pediatric population have not been fully established for this formulation.

Adverse Reactions

Faritol S is generally well-tolerated when used at the recommended dosage. However, as with any bioactive substance, adverse reactions are possible, though not everyone experiences them.

Most side effects are mild and transient. Allergic reactions are possible in individuals with hypersensitivity to the components. These may manifest as skin rash, itching, urticaria (hives), redness of the skin, or, in rare cases, more severe reactions such as angioedema.

Due to the presence of Glycyrrhiza root extract, with prolonged and excessive use beyond recommended durations and doses, electrolyte disturbances may occur. These can include hypokalemia (low potassium levels), which may present as muscle weakness, cramps, or palpitations, as well as sodium and water retention, leading to edema (swelling) and an increase in blood pressure.

Gastrointestinal discomfort, such as mild nausea or epigastric discomfort, has been rarely reported. The sorbitol content may have a mild laxative effect in sensitive individuals or when consumed in large quantities.

If any adverse reactions occur, use of the product should be discontinued immediately, and a healthcare professional should be consulted for advice on symptom management.

Drug Interactions

While Faritol S is a dietary supplement, the active components have the potential to interact with certain medications. It is crucial to inform your healthcare provider about all the products you are taking, including prescription drugs, over-the-counter medicines, and other dietary supplements.

Glycyrrhiza root extract may reduce serum potassium levels. Concomitant use with the following medications requires caution and monitoring: Diuretics, especially thiazide and loop diuretics (e.g., hydrochlorothiazide, furosemide), as this can potentiate the risk of severe hypokalemia. Corticosteroids (e.g., prednisone, hydrocortisone) can also enhance the potassium-wasting effects. Digoxin (a cardiac glycoside) – hypokalemia can increase the risk of digoxin toxicity, which is a serious condition.

Glycyrrhiza may also counteract the effects of antihypertensive drugs due to its potential to cause water retention and elevate blood pressure, potentially reducing their efficacy.

Ascorbic Acid (Vitamin C) in high doses can affect the excretion of certain drugs. It may acidify urine, which can alter the renal excretion of drugs such as amphetamines and salicylates (like aspirin). It may also increase the absorption of iron supplements. Patients on warfarin or other anticoagulants should be aware that large doses of vitamin C might theoretically affect coagulation parameters, though the dose in this product is moderate.

To minimize the risk of interactions, a time interval of 1-2 hours between taking Faritol S and other oral medications is generally advisable, unless otherwise directed by a physician.

Overdose

Acute overdose with Faritol S is unlikely due to its presentation as lozenges; however, ingestion of a significantly large number of tablets in a short period could lead to adverse effects.

Symptoms of overdose would likely be an exaggeration of the known adverse reactions. Primarily, gastrointestinal distress such as nausea, abdominal pain, and diarrhea (due to the sorbitol content) could occur. Excessive intake of Glycyrrhiza components could lead to symptoms of pseudoaldosteronism, including severe headache, hypertension, edema, muscle weakness (due to hypokalemia), and cardiac arrhythmias in susceptible individuals. Very high doses of ascorbic acid may cause gastrointestinal upset and diarrhea.

There is no specific antidote for an overdose of Faritol S. Management should be symptomatic and supportive. In case of suspected overdose, discontinue the product immediately.

If a large quantity has been ingested, seek immediate medical attention or contact a Poison Control Center. Gastric lavage or administration of activated charcoal may be considered if the ingestion is very recent. Monitoring of electrolyte levels, particularly potassium, and blood pressure may be necessary in cases of significant Glycyrrhiza overdose. It is important to bring the product packaging to the medical facility to assist healthcare professionals.

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.