DECVADOL

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEKVADOL (DEKVADOL)

Composition:

Active substances:

1 tablet contains decquiline chloride 0.25 mg, cincocaine hydrochloride (dibucaine hydrochloride) 0.03 mg;

Excipients:

tablets with mint flavour: sorbitol (E 420), talc, magnesium stearate, colloidal anhydrous silicon dioxide, peppermint oil, food flavouring powder (mint);

tablets with lemon flavour: sorbitol (E 420), talc, magnesium stearate, colloidal anhydrous silicon dioxide, food flavouring "Lemon" (liquid);

tablets with raspberry flavour: sorbitol (E 420), talc, magnesium stearate, colloidal anhydrous silicon dioxide, food flavouring "Strawberry" (liquid), food flavouring powder (raspberry);

tablets with coconut flavour: sorbitol (E 420), talc, magnesium stearate, colloidal anhydrous silicon dioxide, food flavouring "Coconut" (liquid).

Pharmaceutical form. Effervescent tablets.

Main physicochemical properties:

tablets with mint flavour: white, flat cylindrical tablets with bevelled edges and a score line on one side, with the taste and odour of mint;

tablets with lemon flavour: white, flat cylindrical tablets with bevelled edges and a score line on one side, with the taste and odour of lemon;

tablets with raspberry flavour: white, flat cylindrical tablets with bevelled edges and a score line on one side, with the taste and odour of raspberry;

tablets with coconut flavour: white, flat cylindrical tablets with bevelled edges and a score line on one side, with the taste and odour of coconut.

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

Pharmacological properties.

Pharmacodynamics.

As a bactericidal and fungistatic agent, benzalkonium 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 accompanying infections of the oral cavity and throat.

Microorganisms resistant to benzalkonium chloride are unknown.

Does not cause caries formation.

Pharmacokinetics.

The main active ingredient is absorbed in very insignificant 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. Decadole is also recommended for use in cases of unpleasant mouth odor.

Decadole may be used in cases of mixed infections of the oral cavity and throat (as recommended by a physician); as an adjunctive medicinal product in the treatment of catarrhal angina, lacunar angina, and Plaut–Vincent angina; in cases of oral and pharyngeal candidiasis.

It is recommended for use 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 simultaneously 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 can be used in patients with diabetes.

The medicinal product contains sorbitol; therefore, it 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 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 or operate machinery have not been conducted. However, the likelihood that the medicinal product may affect reaction speed is very low.

Method of Administration and Dosage.

Adults and children aged 12 years and older

Take 1 tablet every 2 hours; after reduction of inflammatory symptoms – 1 tablet every 4 hours.

Children aged 4 years and older

Take 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.

Tablets should be slowly dissolved in the mouth without chewing. The duration of treatment should be determined individually by a physician. The patient should consult a doctor if symptoms persist or worsen after 5 days of treatment.

Children.

This medicinal product in this pharmaceutical form is not recommended for 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 necrosis of the esophagus.

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

Inducing vomiting and gastric lavage are not recommended.

Side effects.

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, 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.

6 tablets in a blister; 3 blisters in a carton.

6 tablets in a blister; 5 blisters in a cart combust.

12 tablets in a blister; 1 blister in a carton.

12 tablets in a blister; 3 blisters in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business activity.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Website: www.vitamin.com.ua