CELESTA® DUO

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CELISTA® DUO (CELISTA DUO)

Composition:

Active substances: dequalinium chloride, cinchocaine hydrochloride;

1 tablet contains: dequalinium chloride 0.25 mg, cinchocaine hydrochloride (dibucaine hydrochloride) 0.03 mg;

Excipients: sorbitol (E 420), talc, colloidal anhydrous silicon dioxide, magnesium stearate, peppermint flavor, peppermint oil.

Pharmaceutical form. Effervescent tablets for oral administration.

Main physical and chemical properties: white or almost white, round tablets with a score line on one side and beveled edges on both sides.

Pharmacotherapeutic group. Preparations used in throat disorders. ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

As a bactericidal and fungistatic agent, decqualinium 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 the pain symptoms associated with infections of the oral cavity and throat.

Microorganisms resistant to decqualinium chloride are unknown.

Does not cause caries formation.

Pharmacokinetics.

The main active ingredient is absorbed in a very insignificant amount.

Clinical characteristics.

Indications.

For local treatment of acute inflammatory diseases of the oral cavity and throat: gingivitis, ulcerative and aphthous stomatitis, tonsillitis, laryngitis, and pharyngitis.

The medicinal product Celist® Duo is also recommended for use in cases of oral malodor.

The medicinal product Celist® Duo may be used:

‒ in cases of mixed infections of the oral cavity and throat (on physician's advice);

‒ as an adjunctive agent in the treatment of catarrhal tonsillitis, follicular 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 dequalinium chloride, chinchoaine hydrochloride (dibucaine hydrochloride), other quaternary ammonium compounds (e.g., benzalkonium chloride), or any excipient of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

The antibacterial activity of dequalinium is reduced when used concomitantly with anionic surfactants, which may be present in toothpastes.

The use of this medicinal product should not be combined with 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 rare hereditary disorders such 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. The medicinal product may be used during pregnancy only after consultation with a physician, if the expected 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; therefore, the medicinal product is not recommended for use during breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Studies on the effect of the medicinal product on the ability to drive or operate machinery have not been conducted. However, the likelihood of such an effect is very low.

Method of administration and dosage.

Adults and children aged 12 years and older

Administer 1 tablet every 2 hours; after reduction of inflammatory symptoms ‒ 1 tablet every 4 hours.

Children aged 4 years and older

Administer 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 slowly dissolved without chewing. The duration of treatment is determined individually by a physician. The patient should consult a doctor if symptoms persist or worsen after 5 days of using the medicinal product.

Children.

The medicinal product in this dosage form is contraindicated in children under 4 years of age.

Overdose.

The medicinal product is generally well tolerated. In case of overdose, nausea and vomiting may occur; in rare cases, ulcers and esophageal necrosis are possible.

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

Do not induce vomiting or perform gastric lavage.

Side effects.

Hypersensitivity reactions may occasionally occur after using the medicinal product, such as rash, itching, burning sensation, and irritation of the oral and pharyngeal mucosa. 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 immediately for further management.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product registration is an important procedure. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals must report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets per blister; 1 or 4 blisters per carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of business activity.

13, Boryspilska Street, Kyiv, 02093, Ukraine.