Hexoral tablets, tablets 20 pcs

Stomatitis, Inflammation of the gums, Inflammation in the mouth, Pharyngitis, Angina, Sore throatInfectious and inflammatory diseases of the throat or oral cavity:

– Pharyngitis, angina and other inflammatory diseases of the throat;

– Stomatitis;

– Gingivitis.

Active ingredient

Benzocaine, Chlorhexidine

Composition

1 tablet contains:

The active ingredients:

Chlorhexidine dihydrochloride – 5 mg,

benzocaine – 1.5 mg.

Auxiliary substances:

isomalt – 2243.681 mg,

peppermint oil – 0.9 mg,

menthol – 0.645 mg,

thymol – 0.045 mg,

aspartame – 2.29 mg,

purified water – 45.789 mg.

How to take, the dosage

Topically. The tablet should be slowly dissolved in the mouth until complete dissolution.

The drug should be started immediately after the appearance of the first symptoms and continued for several days after the disappearance of symptoms.

General dosage recommendations:

• Adults and children over 12 years: 1 tablet every 1-2 hours as needed, but no more than 8 tablets per day, unless otherwise prescribed.
• Children aged 4-12 years: up to 4 tablets per day.

For use in children, consult your doctor.

Do not use in children under 4 years.

Information for diabetics: the carbohydrate content in one tablet corresponds to 0.1 bread units (BU).

Interaction

Benzocaine due to the formation of its metabolite 4-aminobenzoic acid reduces the antibacterial activity of sulfonamides and aminosalicylates. Sucrose, polysorbate 80, insoluble salts of magnesium, zinc and calcium reduce the effect of chlorhexidine.

Special Instructions

Benzocaine may cause methemoglobinemia. This condition is manifested by symptoms such as a change in the color of the skin, lips and nail beds to gray or blue or pale; headache, fainting, shortness of breath, fatigue and tachycardia.

The appearance of these symptoms indicates the presence of moderate to high amounts of methemoglobin and a significant decrease in oxygen transport function of the blood.

Children, elderly patients may be at higher risk of methemoglobinemia.
In children the drug should be used under the supervision of adults.

The drug contains aspartame which is a derivative of phenylalanine that is dangerous for patients with phenylketonuria.

It is contraindicated in case of wounds and ulcers of the mouth or throat.

It is necessary to observe caution while using the drug in children of infants and individuals with aspiration or swallowing disorders due to the danger of suffocation.

If the drug is out of date or expired – do not throw it in the sewage and outdoors! Place the medicine in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

Round biconvex opaque tablets with a rough surface of white or yellowish-white to light gray or yellowish-gray. Unevenness of coloring, the presence of air bubbles and slight roughness of edges is allowed. There may be a white coating (powdering).

Contraindications

• High sensitivity to any of the ingredients of the drug;
• wound and ulcerative lesions of the oral cavity or throat;
• Low plasma cholinesterase concentration;
• phenylketonuria;
• children under 4 years of age.

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Side effects

Adverse reactions detected during post-registration use of the drug were classified as follows: Very frequent (≥10%), Frequent (≥1% but < 10%), Infrequent (≥0.1% but < 1%), Rare (≥0.01% but < 0.1%), Very rare (< 0.01%), Frequency unknown (incidence cannot be estimated based on available data).

The adverse reactions listed below have been classified according to

1) data from clinical or epidemiological studies, or

2) in cases where the number of cases is unknown or information about the adverse reaction is revealed by analysis of literature data, “Frequency unknown” is indicated.

According to spontaneous reports of adverse reactions*

Gastrointestinal disorders. Frequency is not known: decreased sensitivity of the oral mucosa, temporary tongue numbness, taste disorders (dysgeusia), tooth discoloration, discoloration of the tongue (reversible), discoloration of silicate and composite materials of dental restoration, plaque (tartar) formation, stomatitis, oral mucosa detachment, glossodynia, increased parotid salivary glands.

Immune system disorders. Frequency is unknown: hypersensitivity reactions (including severe allergic reactions, urticaria, angioedema, anaphylactic reactions, anaphylactic shock).

Blood and lymphatic system disorders. Frequency is unknown: methemoglobinemia.

*According to the literature data.

If any of the side effects specified in the instructions are aggravated, or if you notice any other side effects not specified in the instructions, inform the doctor.

Overdose

When used properly, overdose of the drug is impossible, since chlorhexidine is practically not absorbed into the blood, and the amount of absorbed benzocaine is extremely small.

Chlorhexidine

Chlorhexidine hydrochloride is poorly soluble in water, all cases of overdose are described only when taking water-soluble chlorhexidine gluconate. In these cases, mucosal damage by direct contact with chlorhexidine gluconate and a systematic reversible increase in hepatic enzyme concentrations have been noted. There is no specific treatment.

Benzocaine

Overdose is possible only with improper use.

Symptoms: possible toxic effects on the central nervous system, manifested initially by tremor, vomiting, convulsions, and later – CNS depression. Coma may occur due to respiratory depression. High toxic concentrations cause bradycardia, atrioventricular conduction blockade and cardiac arrest. Benzocaine may cause methemoglobinemia (especially in children), accompanied by choking and cyanosis.

Treatment: induce vomiting and gastric lavage. In hypoxia and anoxia it is recommended artificial respiration with oxygen support, in case of cardiac arrest – cardiac massage.

In convulsions diazepam or fast-acting barbiturates are prescribed (contraindicated for anoxic convulsions); in particularly severe cases after intubation and artificial respiration suxamethonium chloride is used. Blood circulation should be supported by administration of blood plasma or electrolyte solutions.

In case of methemoglobinemia up to 50 ml of 1% solution of methylene blue intravenously can be used.

Pregnancy use

There is no sufficient experience of using the drug in pregnant and lactating women.

Use of the drug “Hexoral® tabs” during pregnancy and lactation is possible only in cases when the expected benefits to the mother exceed the potential risk of harmful effects to the fetus and child.