Lisobact®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LYSOBACT® (LYSOBACT®)

Composition:

Active ingredients: 1 compressed lozenge contains lysozyme hydrochloride 20 mg, corresponding to 800,000 FIP U (FIP units of activity); pyridoxine hydrochloride 10 mg;

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

Pharmaceutical form. Compressed lozenges.

Main physicochemical properties: round, compressed lozenges, white to almost white, with a flat, smooth surface and a break line on one side.

Pharmacotherapeutic group.

Preparations used for throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological Properties.

Pharmacodynamics.

Lysozyme is a mucopolysaccharide effective against gram-positive bacteria due to its ability to convert insoluble polysaccharides of the cell wall into soluble mukopeptides. It is also effective against gram-negative bacteria, viruses, and fungi. Lysozyme exhibits local anti-inflammatory activity and enhances the body's non-specific resistance. Pyridoxine exerts a protective effect on the oral mucosa and has an anti-aphthous effect.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

Concomitant local treatment of diseases:

• of the oral mucosa, including aphthous stomatitis;
• of the throat: acute tonsillitis (angina), chronic tonsillitis, pharyngitis;
• in the postoperative period (after tonsillectomy, cryodestruction of palatine tonsils).

Contraindications.

Hypersensitivity to any component of the medicinal product, including allergy to lysozyme or egg protein.

Interaction with other medicinal products and other types of interactions.

LISOBACT® should not be used simultaneously with other medicinal products containing antiseptics, as well as when other medicinal products containing pyridoxine hydrochloride are prescribed.

Lysozyme enhances the effectiveness of antibacterial agents such as penicillin, chloramphenicol.

Isoniazid, penicillamine, pyrazinamide, hydralazine, immunosuppressants, estrogens (including oral contraceptives containing estrogens) may increase the requirement for pyridoxine, as they act as antagonists of pyridoxine or enhance its renal excretion.

Pyridoxine hydrochloride enhances decarboxylation and reduces the effectiveness of levodopa in the treatment of Parkinson's disease.

Special precautions for use.

The medicinal product is not intended for long-term use.

To prevent disruption of the normal oral cavity microflora, the drug should not be used for more than 5 days.

The medicinal product contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this drug. Patients with known sugar intolerances should consult their physician before taking this medicinal product.

If symptoms such as severe sore throat, headache, nausea, vomiting, or high body temperature occur, or if symptoms of illness do not resolve within 5 days of treatment with the drug, medical advice should be sought.

In case of bacterial infection, consult a physician regarding the appropriateness of systemic antibiotic therapy.

Prolonged use of high doses of pyridoxine (more than 200 mg per day) over a long period (from several months to a year) may lead to deterioration of liver and kidney function, and sensory neuropathy, which usually resolves after discontinuation of treatment. Therefore, the use of LISOBACT® is not recommended in patients with impaired liver or kidney function who are receiving other medicinal products containing pyridoxine hydrochloride.

Since increased gastric acidity may occur with pyridoxine doses exceeding 30 mg/day, the drug should be used with caution in patients with peptic ulcer of the stomach or duodenum.

Use during pregnancy or breastfeeding.

Pyridoxine: Adequate and well-controlled studies in pregnant women have shown no teratogenic effects or adverse effects on fetal development.

Lysozyme: Animal studies have shown no teratogenic effects of lysozyme. However, there is insufficient data on the effects of lysozyme on the fetus. Therefore, use of the drug during pregnancy is not recommended.

Due to insufficient data on the excretion of lysozyme in human milk and the high content of pyridoxine, use of the drug during breastfeeding is not recommended.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Dosage and Administration

The medication is intended for use in adults and children aged 3 years and older.

Adults and children aged 12 years and older: 2 lozenges 3–4 times daily.

Children aged 3 to 7 years: 1 lozenge no more than 3 times daily.

Children aged 7 to 12 years: 1 lozenge no more than 4 times daily.

Slowly dissolve the lozenges, retaining the resulting solution in the mouth for some time. The interval between doses should be no less than 1 hour. The duration of treatment is 5 days.

Children.

The medication must not be used in children under 3 years of age.

Overdose.

When using LISOBACT® in doses significantly exceeding the recommended ones, clinically significant consequences are not expected.

The product contains pyridoxine; therefore, prolonged use of pyridoxine (more than 6–12 months) at doses exceeding 200 mg may lead to peripheral sensory neuropathy, which usually resolves after discontinuation of treatment.

Side effects.

Immune system side effects: anaphylactic shock, anaphylactic reactions, angioedema.

Skin side effects: urticaria, rash, itching, photosensitivity.

Gastrointestinal side effects: occasionally increased gastric juice acidity.

Healthcare professionals, patients, and pharmacists are kindly requested to report any suspicion of adverse reactions or lack of therapeutic effect to the email address of Bosnalijek d.d. representative: [email protected].

Shelf life.

5 years.

Storage conditions.

Store out of reach of children at a temperature not exceeding 30 °C.

Packaging.

10 compressed lozenges in a blister pack, № 10 (10×1) or № 30 (10×3) in a cardboard box.

Availability.

Over-the-counter.

Manufacturer/Applicant.

Bosnalijek d.d.

Manufacturer's address and place of business.

71000, Yukicheva 53, Sarajevo, Bosnia and Herzegovina.