LISOBACT DUO®

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

Composition:

Active substances: lysozyme hydrochloride, cetylpyridinium chloride;

1 compressed lozenge contains 20.0 mg of lysozyme hydrochloride, equivalent to 800,000 FIP units; 1.5 mg of cetylpyridinium chloride;

Excipients: sorbitol (E 420), povidone, peppermint flavoring, magnesium stearate.

Pharmaceutical form. Compressed lozenges.

Main physicochemical characteristics: white or almost white, round, biconvex compressed lozenges.

Pharmacotherapeutic group.

Preparations used for throat disorders. Antiseptics.

ATC code: R02AA20.

Pharmacological properties.

Pharmacodynamics.

Lysozyme is a physiological mucopolysaccharide effective against Gram-positive bacteria and viruses. Lysozyme exhibits local anti-inflammatory activity by reducing histamine release.

Cetylpyridinium is an antiseptic from the group of quaternary ammonium compounds. Cetylpyridinium chloride exerts antibacterial activity against Gram-positive and Gram-negative bacteria. It has a disinfectant effect on mucous membranes.

Antibacterial activity against Staphylococcus aureus under the following conditions: temperature 35 °C and contact time 15 minutes.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

Additional local treatment of moderate sore throat inflammation without fever.

As additional local therapy for diseases of:

• oral mucosa: stomatitis (including aphthous stomatitis), gingivitis;
• throat: adjunctive treatment of laryngitis and pharyngitis.

In pre- and postoperative periods following tonsillectomy, laryngeal surgery, injuries or abscesses, and after tooth extraction.

Contraindications.

• Hypersensitivity to lysozyme hydrochloride, cetylpyridinium chloride, or to any of the excipients, including allergy to lysozyme or allergy to egg protein;
• hypersensitivity to egg protein;
• fructose intolerance (due to sorbitol content).

Interaction with other medicinal products and other forms of interaction.

Currently, no interactions are known.

Special precautions for use.

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

To prevent disruption of the normal oral flora with a risk of bacterial or fungal spread, the product should not be used for more than 5 days. If symptoms such as severe sore throat, headache, nausea, vomiting occur, or if symptoms of illness do not resolve within 5 days and/or if high body temperature persists, medical advice must be sought.

It is not recommended to exceed the recommended doses.

Special warnings regarding excipients.

The product contains sorbitol. Patients with the rare hereditary condition of fructose intolerance should not take this medicinal product.

Acute, severe hypersensitivity reactions such as urticaria, angioedema (including of the respiratory tract), bronchospasm, circulatory complications, and anaphylactic shock may occur during use of this medicinal product. In addition, isolated cases of serious skin reactions, such as erythema multiforme and Stevens–Johnson syndrome, have been reported. Some of these serious reactions have been life-threatening. The use of this product should be discontinued immediately if symptoms of hypersensitivity reactions occur.

Use during pregnancy or breastfeeding.

Data on the safety of using this medicinal product during pregnancy or breastfeeding are limited; therefore, use of the product should be avoided during pregnancy or breastfeeding.

Pregnancy. There are no reliable animal data on teratogenicity for any of the components of this medicinal product.

Currently, there are no adequate clinical data to assess potential adverse or fetotoxic effects of this product. Standard precautions regarding medication use during pregnancy should be observed when using LISOBACT DUO®. Therefore, the product is not recommended during pregnancy.

Breastfeeding period. Since it is unknown whether the components of the medicinal product pass into breast milk, LISOBACT DUO® is not recommended for women who are breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage.

The recommended dose for adults and children aged 6 years and older is 3–6 lozenges per day. The interval between administration of each subsequent dose should be at least 2 hours.

The lozenge should be slowly dissolved, retaining the resulting solution in the mouth for some time.

Duration of treatment — 5 days.

Children.

Not recommended for children under 6 years of age.

Overdose.

Data not available.

Side effects.

Immune system disorders: anaphylactic shock, anaphylactic reactions, Quincke's edema (see section "Special precautions").

Skin disorders: urticaria, rash, pruritus, erythema multiforme, Stevens-Johnson syndrome (see section "Special precautions").

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 10 compressed lozenges in a blister, 2 blisters in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer: Bosnalijk d.d.

Manufacturer's address and place of business.
Yukicheva 53, 71000 Sarajevo, Bosnia and Herzegovina.

Marketing Authorization Holder: Bosnalijk d.d.

If adverse reactions occur or if the medicinal product is ineffective, please contact the Bosnalijk d.d. representative at the following email address: [email protected]

Address of the Marketing Authorization Holder.
Yukicheva 53, 71000 Sarajevo, Bosnia and Herzegovina.

Representative of the Marketing Authorization Holder in Ukraine: [email protected]