AMILAR® IS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMILAR® IS

Composition:

Active substances: dequalinium chloride, dibucaine hydrochloride;

1 tablet contains dequalinium chloride 0.25 mg, dibucaine hydrochloride 0.03 mg;

Excipients: sorbitol (E 420), colloidal anhydrous silicon dioxide, talc, magnesium stearate, flavoring agent (natural peppermint, or natural cherry, or natural orange).

Pharmaceutical form. Lozenges.

Main physicochemical properties: white or almost white tablets, flat cylindrical in shape with beveled edges.

Pharmacotherapeutic group.

Preparations used for throat diseases. ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

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

Resistant microorganisms to dequalinium chloride have not been reported.

Does not promote 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. Amilar® IS is also recommended for use in cases of bad breath.

Amilar® IS may be used in mixed infections of the oral cavity and throat (on physician's advice); as an adjunctive medicinal 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, toothpaste. The use of this medicinal product should not be combined with the intake of cholinesterase inhibitors.

Special precautions for use.

Since the medicinal product 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 the rare hereditary condition known as fructose intolerance.

Use with caution in patients with low plasma cholinesterase levels.

Use during pregnancy or breastfeeding.

Pregnancy

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

Breastfeeding period

Clinical studies on the passage of active substances into breast milk have not been conducted. The medicinal product is not recommended for use during breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Studies on the effect of the medicinal product on the ability to drive vehicles or operate machinery have not been conducted. However, the likelihood that the medicinal product may have any negative effect in this regard is very low.

Method of Administration and Dosage.

For adults and children aged 12 years and older

Administer 1 tablet every 2 hours. After reduction of inflammation symptoms, administer 1 tablet every 4 hours.

For children aged 4 years and older

Administer 1 tablet every 3 hours. After reduction of inflammation symptoms, administer 1 tablet every 4 hours.

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

Tablets should be slowly dissolved in the mouth, without chewing. The duration of treatment is determined individually by a physician. The patient should consult a doctor if symptoms have not improved or worsened after 5 days of treatment.

Children.

This medicinal product in this dosage form should not be administered to children under 4 years of age.

Overdose.

Generally, the medicinal product is 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, protective (coating) agents may be used.

Inducing vomiting and gastric lavage are not recommended.

Side effects.

Hypersensitivity reactions may sometimes occur after using 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, discontinue use of the medicinal product and consult a physician for further therapy.

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.

8 tablets in a blister; 1 or 2 blisters per pack.

Dispensing category. Over-the-counter.

Manufacturer.

Limited liability company "INTERSHEM".

Manufacturer's address and place of business.

40-A, 21st km of Starokyivska Road, Odesa, Ukraine, 65025.