Hexoral^® tabs classic (Tablets) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.) (India)

Contact Information

J&JTL LLC (Russia)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Dichlorobenzyl alcohol (Grouping name)

Amylmetacresol (Rec.INN registered by WHO)

Dosage Forms

	Hexoral® tabs classic	Lozenges (blackcurrant) 0.6 mg+1.2 mg: 8, 12, 16 or 24 pcs.
		Lozenges (orange) 0.6 mg+1.2 mg: 8, 12, 16 or 24 pcs.
		Lozenges (lemon) 0.6 mg+1.2 mg: 8, 12, 16 or 24 pcs.
		Lozenges (honey-lemon) 0.6 mg+1.2 mg: 8, 12, 16 or 24 pcs.

Dosage Form, Packaging, and Composition

Lozenges (orange) orange in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose – 1618 mg, dextrose – 830.4 mg, citric acid monohydrate – 21 mg, orange oil – 7.515 mg, anise seed oil – 2.53 mg, cornmint leaf oil – 1.32 mg, sunset yellow FCF dye – 0.3 mg.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.

Lozenges (lemon) yellow in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose – 1618 mg, dextrose – 830.4 mg, citric acid monohydrate – 21 mg, anise seed oil – 2.53 mg, cornmint leaf oil – 1.32 mg, lemon oil concentrate – 7.7 mg, quinoline yellow dye – 0.175 mg.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.

Lozenges (honey-lemon) from brownish-yellow to brown in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose – 1618 mg, dextrose – 830.4 mg, cornmint leaf oil – 1.25 mg, lemon oil – 1.25 mg, honey flavor – 7.5 mg, caramel color – 0.625 mg, sunset yellow FCF dye – 0.0375 mg.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.

Lozenges (blackcurrant) purple in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose – 1618 mg, dextrose – 830.4 mg, citric acid monohydrate – 15 mg, cornmint leaf oil – 1.25 mg, blackcurrant flavor – 6.25 mg, azorubine dye – 0.0625 mg, brilliant blue FCF dye – 0.0275 mg.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The drug has an antiseptic effect, is active against gram-positive and gram-negative microorganisms in vitro, and has an antifungal effect.

Indications

• Symptomatic treatment of infectious and inflammatory diseases of the oral cavity and pharynx.

ICD codes

Dosage Regimen

Use the drug topically only. Dissolve one lozenge slowly in the mouth until it is completely dissolved.

For adults and children over 6 years of age, administer one lozenge every 2-3 hours as needed for symptom relief.

Do not exceed the maximum daily dose of 8 lozenges within a 24-hour period.

Limit the total duration of treatment to 5-7 days. Discontinue use if symptoms persist or worsen beyond this period.

Ensure the patient is capable of dissolving a lozenge safely. Supervise children to prevent a choking hazard.

Consider the sucrose content (1.618 g per lozenge, 0.20 XE) in patients with diabetes mellitus or those on a controlled diet.

Do not use in children under 6 years of age due to risk of choking and aspiration.

Do not chew or swallow the lozenge whole. The therapeutic effect is achieved through gradual dissolution in the oral cavity.

Adverse Reactions

Possible allergic reactions (burning sensation in the oral cavity).

If reactions not described in the instructions for use occur, the patient should consult a doctor about the advisability of further use of the drug.

Contraindications

• Hypersensitivity to the components of the drug;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Children under 6 years of age.

With caution

Patients with dysphagia (difficulty swallowing) and/or a tendency to aspiration.

Use in Pregnancy and Lactation

Use of the drug during pregnancy and breastfeeding is possible only under medical supervision and only if the intended benefit to the mother outweighs the risk to the fetus and child.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Do not exceed the indicated doses.

The drug should not be used in case of increased individual sensitivity to any component included in the drug.

If the symptoms of the disease worsen, persist, or new symptoms appear, it is necessary to stop taking the drug and consult a doctor.

The drug contains sucrose, which should be taken into account by patients suffering from diabetes mellitus, as well as persons on a low-calorie diet. One lozenge contains 1618.0 mg of sucrose, which corresponds to 0.20 Bread Units (XE).

Taking the tablets may pose a choking hazard.

The drug should be stored out of the reach of children. If a child swallows the drug, seek medical attention immediately.

If the medicine is spoiled or the expiration date has passed, it should not be disposed of in sewage or on the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms nausea, vomiting, diarrhea.

Treatment symptomatic.

Drug Interactions

Clinically significant interaction with drugs of other groups has not been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 4 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.