Lysobact^® (Tablets) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Lysozyme (DCF adopted for use in France)

Dosage Form

Lysobact®

Lozenges 20 mg+10 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Lozenges from white to almost white in color, round, with a flat and smooth surface, intact edges, and a break line on one side.

Excipients: lactose monohydrate, hypromellose, magnesium stearate, sodium saccharin, vanillin.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptics

Pharmacological Action

A combined antiseptic for topical use. Its action is due to the components in its composition.

Lysozyme is an enzyme of a protein nature, used as an antiseptic due to its direct effect on gram-positive and gram-negative bacteria, as well as fungi and viruses. It participates in the regulation of local non-specific immunity.

Pyridoxine has a protective effect on the oral mucosa (exerts an anti-aphthous effect). It does not affect the pharmacodynamic properties of lysozyme.

Indications

Treatment of infectious and inflammatory diseases of the oral mucosa, gums, and larynx

• Gingivitis;
• Stomatitis;
• Catarrhal phenomena of the upper respiratory tract;
• Aphthous ulcerations;
• Herpetic lesions of the oral mucosa (as part of combination therapy);
• Erosions of the oral mucosa of various etiologies.

ICD codes

Dosage Regimen

Apply topically in the oral cavity. Dissolve the lozenge slowly in the mouth until completely dissolved.

For children aged 3 to 7 years, administer 1 tablet 3 times daily.

For children aged 7 to 12 years, administer 1 tablet 4 times daily.

For adults and children over 12 years, administer 2 tablets 3 to 4 times daily.

Maintain regular intervals between doses for consistent therapeutic effect.

The standard course of treatment is 8 days. Do not exceed the recommended duration without medical consultation.

For herpetic lesions of the oral mucosa, use only as part of a combination therapy regimen as directed by a physician.

If symptoms persist after the 8-day course, discontinue use and seek medical advice.

Adverse Reactions

Allergic reactions angioneurotic edema (Quincke’s edema), urticaria, bronchospasm, very rarely – erythema multiforme exudativum.

Contraindications

• Hypersensitivity to lysozyme, pyridoxine;
• Children under 3 years of age;
• Allergy to chicken egg white.

Use in Pregnancy and Lactation

This product can be used during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

If an allergic reaction occurs, the use of the drug should be discontinued. In such cases, the patient should consult a doctor.

Drug Interactions

When used concomitantly, it enhances the effect of antibiotics, including penicillin, chloramphenicol, nitrofurantoin, enhances the effect of diuretics, and weakens the activity of levodopa.

Isoniazid, penicillamine, pyrazinamide, immunosuppressants, estrogens, and oral contraceptives may increase the need for pyridoxine (antagonistic action towards pyridoxine or increased renal excretion).

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.