Faritol M (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Faritol M

Lozenges: 20 pcs.

Dosage Form, Packaging, and Product Composition

Lozenges with a mass of 1100 mg.

* from peppermint leaf extract and sage leaf extract.

Auxiliary substances : dextrose (glucose) monohydrate, carrier (polyvinylpyrrolidone), anti-caking agents (silicon dioxide amorphous, magnesium salt of stearic acid (magnesium stearate), talc), sweetener (steviol glycosides), natural flavor “Sage essential oil”.

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

Therapeutic Category

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

Indications

• As a dietary supplement to the diet, it is an additional source of flavonoids and vitamin C.
• Contributes to the normalization of the state of the upper respiratory tract and the oropharyngeal mucosa.
• Used to support the body in inflammatory conditions of the oral cavity and pharynx, such as pharyngitis, laryngitis, and gingivitis, as part of complex therapy.
• Helps reduce discomfort in the throat, including soreness, irritation, and dryness, providing a soothing effect.
• Recommended for use during seasonal colds and respiratory infections to help alleviate associated symptoms.

Contraindications

• Individual hypersensitivity to any of the components of the dietary supplement, including sage, peppermint, ginger, or any of the auxiliary substances.
• Pregnancy and breastfeeding due to the lack of sufficient clinical data on safety during these periods. The effects of sage and high-dose peppermint extracts require particular caution.
• Children under 14 years of age, as the safety and efficacy for this age group have not been established.
• Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, as the product contains dextrose (glucose).
• Patients with gastroesophageal reflux disease (GERD) or biliary tract disorders, as peppermint and ginger may exacerbate symptoms in some individuals.
• Patients with epilepsy or a history of convulsive seizures should use with caution, as sage essential oil has been reported to have potential neurotoxic effects in high doses.

Dosage Regimen

Adults and children over 14 years of age: Dissolve 1 lozenge in the mouth 3 to 4 times per day.

The lozenge should be allowed to dissolve slowly in the mouth; do not chew or swallow whole. This ensures a prolonged local effect on the mucous membrane of the mouth and throat.

The duration of continuous use should not exceed 2 weeks. If symptoms persist or worsen after this period, it is necessary to discontinue use and consult a physician for further evaluation.

The dietary supplement is intended for use as part of a balanced diet and should not be used as a substitute for a varied diet or a healthy lifestyle. Do not exceed the recommended daily dose.

Adverse Reactions

Faritol M is generally well-tolerated when used at the recommended dosage. However, in rare cases, allergic reactions may occur. These can manifest as skin rash, itching, urticaria, or, in very rare instances, more severe reactions such as angioedema.

Due to the presence of menthol and essential oils, some individuals may experience local irritation of the oral mucosa, a mild burning sensation, or tingling.

In cases of individual sensitivity to the components of the supplement, gastrointestinal discomfort, such as heartburn, nausea, or abdominal pain, may occur, particularly in individuals with a predisposition.

If any adverse reactions are noted, discontinue use immediately and seek medical advice if necessary. Reporting adverse events to your healthcare provider is important for safety monitoring.

Drug Interactions

While significant drug interactions are not well-documented for this dietary supplement, a pharmacological assessment suggests potential considerations.

The sage leaf extract may have mild hypoglycemic effects. Patients taking antidiabetic medications (e.g., insulin, metformin, sulfonylureas) should monitor their blood glucose levels more closely, as an additive effect is theoretically possible.

Sage has been traditionally noted for its potential to affect the central nervous system. Concomitant use with sedatives, anticonvulsants, or other CNS-depressant drugs should be approached with caution, though the clinical relevance at this dosage is likely low.

Vitamin C (ascorbic acid) in high doses can influence the absorption and metabolism of certain drugs. While the dose in this supplement is moderate, it may theoretically increase the absorption of iron supplements and could potentially interact with drugs like warfarin, though evidence is limited. It is always prudent to inform your doctor about all the supplements and medications you are taking.

Overdose

Acute overdose with Faritol M is unlikely due to the form of the product (lozenges). However, exceeding the recommended daily dose may lead to an increased risk of adverse reactions.

Symptoms of overdose could primarily involve gastrointestinal distress, including nausea, vomiting, abdominal pain, and diarrhea, due to the concentrated plant extracts and menthol.

In cases of significant ingestion beyond the recommended amount, neurological symptoms such as dizziness, lethargy, or, in extreme cases with sage oil, tremors or convulsions could theoretically occur, though this is highly improbable with the formulated lozenge dosage.

There is no specific antidote. In case of suspected overdose, discontinue use immediately and seek medical attention or contact a poison control center. Treatment is expected to be symptomatic and supportive.

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.