Hexalyse^® (Tablets) Instructions for Use

Marketing Authorization Holder

Laboratoires Bouchara-Recordati (France)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Lysozyme (DCF adopted for use in France)

Biclotymol (Rec.INN registered by WHO)

Enoxolone (Rec.INN registered by WHO)

Dosage Form

Hexalyse®

Lozenges 5 mg+5 mg+5 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Lozenges yellow-orange in color, round, flat-cylindrical, with a bevel, with a faint characteristic odor; inclusions of orange or white color are possible.

Excipients: lemon oil – 200 mcg, citric acid monohydrate – 10 mg, dye sunset yellow (E110) – 100 mcg, magnesium stearate – 15 mg, acacia gum – 60 mg, sucrose – up to 1200 mg.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptics

Pharmacological Action

A combined drug for topical use with antimicrobial, antiviral, and anti-inflammatory action.

Biclotymol is an antiseptic. It is active against staphylococci, streptococci, and corynebacteria, and has a local anesthetic and anti-inflammatory effect. When applied topically, it is characterized by a prolonged action.

Lysozyme is a polypeptide mucolytic enzyme that has an antimicrobial effect. It is active against gram-positive bacteria; gram-negative microorganisms are less sensitive to lysozyme. It helps to increase the activity of the body’s non-specific defense factors, has an anti-inflammatory and mucolytic effect. Lysozyme exhibits antiviral activity (forms complexes with viruses). It belongs to the natural factors of the body’s defense.

Enoxolone is a complex triterpene isolated from glycyrrhizic acid. It inhibits 11-beta-hydroxysteroid dehydrogenase, which inactivates cortisol. It has anti-inflammatory, antimicrobial, and antiviral effects.

Pharmacokinetics

Pharmacokinetic studies of the drug Hexalyse^® have not been conducted.

Indications

For the local treatment of infectious and inflammatory diseases of the mucous membrane of the oral cavity, pharynx, and larynx caused by microorganisms sensitive to biclotymol, lysozyme, and enoxolone: acute and chronic pharyngitis; pharyngolaryngitis; tonsillitis; conditions after tonsillectomy; glossitis.

ICD codes

Dosage Regimen

Administer by slow dissolution in the mouth. Do not chew or swallow the lozenge whole.

For adults and children aged 6 years and older, use one lozenge.

Allow the lozenge to dissolve completely. Do not consume food or beverages for at least 15 minutes after administration.

Repeat the dose every 2 to 4 hours as needed for symptom relief.

Do not exceed 8 lozenges in a 24-hour period.

Initiate treatment at the first signs of throat discomfort or infection.

The maximum duration of treatment is 10 days. Do not use continuously for longer than 10 days.

Discontinue use and consult a physician if symptoms persist, worsen, or if high fever, headache, nausea, or vomiting occurs.

For postoperative conditions, such as after tonsillectomy, follow the specific dosage instructions provided by the surgeon.

Adverse Reactions

Possible allergic reactions, superinfection; with long-term use (more than 10 days) – oral dysbiosis with the risk of spreading bacterial and fungal infections.

Contraindications

Children under 6 years of age; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

During pregnancy and lactation (breastfeeding), it is used only for strict indications.

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

If within 5 days the therapeutic effect is absent or weakly expressed, the therapy used should be reconsidered.

Drug Interactions

Concomitant use of other medicinal products for topical application in the oral cavity should be avoided.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.