Laritilen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LARYTYLEN® (LARYTYLEN)

Composition:

Active substances: dequalinium chloride, dibucaine hydrochloride;

1 dispersible tablet contains dequalinium chloride equivalent to 100 % substance 0.25 mg, dibucaine hydrochloride equivalent to 100 % substance 0.03 mg;

Excipients:

Tablets with mint flavor: sorbitol (E 420), talc, colloidal hydrated silicon dioxide, magnesium stearate, peppermint flavoring, peppermint oil;

Tablets with mint and raspberry flavor: sorbitol (E 420), talc, colloidal hydrated silicon dioxide, magnesium stearate, raspberry flavoring, peppermint oil;

Tablets with mint and lemon flavor: sorbitol (E 420), talc, colloidal hydrated silicon dioxide, magnesium stearate, lemon flavoring, peppermint oil.

Pharmaceutical form. Dispersible tablets.

Main physicochemical properties: white, round tablets, bevelled on both sides, with a score line on one side.

Pharmacotherapeutic group. Preparations used in throat disorders.

ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

As a bactericidal and fungistatic agent, benzalkonium chloride affects microorganisms causing mixed infections of the oral cavity and throat. The spectrum of action of this local chemotherapeutic agent is broad and includes most gram-positive and gram-negative bacteria, as well as fungi, spirochetes, and pathogenic microorganisms causing mixed infections of the oral cavity and throat. The accumulation of dibucaine hydrochloride in the body alleviates the pain symptoms accompanying infections of the oral cavity and throat.

Resistant microorganisms to benzalkonium chloride have not been reported.

Does not cause caries formation.

Pharmacokinetics.

The main active ingredient is absorbed in negligible amounts.

Clinical Characteristics.

Indications.

Local treatment of acute inflammatory diseases of the oral cavity and throat: gingivitis, ulcerative and aphthous stomatitis, tonsillitis, laryngitis, and pharyngitis. Larytilene® is also recommended for use in the presence of unpleasant oral odor.

Larytilene® can be used in cases of mixed infections of the oral cavity and throat (as directed by a physician); as an adjunctive agent in the treatment of catarrhal tonsillitis, lacunar tonsillitis, and Plaut-Vincent angina; in cases of oral and pharyngeal candidiasis.

Recommended in the postoperative period following tonsillectomy and tooth extraction.

Contraindications.

Hypersensitivity to any of the substances contained in the medicinal product. Allergy to quaternary ammonium compounds (e.g., benzalkonium chloride).

Interaction with other medicinal products and other forms of interaction.

The antibacterial activity of dequalinium is reduced when used concomitantly with anionic surfactants, for example, as contained in toothpastes. The use of this medicinal product should not be combined with the intake of cholinesterase inhibitors.

Special precautions for use.

Since Laritilen® does not contain sugar, it is suitable for use in patients with diabetes mellitus.

The medicinal product contains sorbitol and therefore should not be used in patients with rare hereditary disorders such as fructose intolerance. Use with caution in patients with low plasma cholinesterase levels.

Use during pregnancy or breastfeeding.

Pregnancy. Controlled clinical studies have not been conducted. Under these circumstances, Laritilen® may be used during pregnancy only after consultation with a physician, if the therapeutic benefit outweighs the potential risk to the fetus.

Breastfeeding period. There are no clinical data available on the passage of active substances into breast milk. The medicinal product is not recommended for use during breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

There are no available data from studies on the effect of the medicinal product on the ability to drive a vehicle or operate machinery. However, the likelihood that Laritilen® may have any negative effect on this ability is very low.

Dosage and Administration.

Adults and children aged 12 years and older

The recommended dose is 1 tablet every 2 hours; after reduction of inflammatory symptoms — 1 tablet every 4 hours.

Children aged 4 years and older

The recommended dose is 1 tablet every 3 hours; after reduction of inflammatory symptoms — 1 tablet every 4 hours.

The maximum daily dose is 10–12 tablets during the acute phase and 6 tablets after inflammatory symptoms have subsided.

The tablets should be sucked slowly without chewing. The duration of treatment is determined individually by a physician. Patients should consult a doctor if symptoms do not improve or worsen after 5 days of treatment.

Children. This medicinal product in the given pharmaceutical form is not recommended for children under 4 years of age.

Overdose.

The drug is generally well tolerated. In case of overdose, nausea and vomiting may occur; in rare cases, esophageal ulcers and necrosis may develop.

Treatment of overdose is symptomatic; if necessary, soothing (protective) agents may be used.

Inducing vomiting and gastric lavage are not recommended, as these measures are not considered appropriate.

Adverse reactions.

Hypersensitivity reactions may occasionally occur after administration of the medicinal product, such as rash, itching, burning sensation, irritation of the mucous membranes of the oral cavity and throat. In rare cases, particularly with abuse, ulceration and necrosis may occur. If any unusual reactions occur, administration of the medicinal product should be discontinued and medical advice must be sought regarding further therapy.

Reporting of suspected adverse reactions after registration of the medicinal product is important. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 tablets per blister, 1, 2 or 4 blisters per carton.

Supply category.

Over-the-counter.

Manufacturer.

JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.