Lisobact duo® spray with peppermint flavor

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LYSOBACT DUO® Spray with peppermint flavor (Lysobact DUO® Spray with peppermint flavor)

Composition:

Active substances: lysozyme hydrochloride, cetylpyridinium chloride;

1 ml of solution contains lysozyme hydrochloride 20.0 mg, corresponding to 800,000 FIP U (Federation Internationale de Pharmacie units of activity); cetylpyridinium chloride 1.5 mg;

Excipients: glycerol 85%, propylene glycol, methylparahydroxybenzoate, sodium saccharin, propylparahydroxybenzoate, peppermint flavoring agent, sodium hydroxide, purified water.

Pharmaceutical form. Oromucosal spray, solution.

Main physicochemical properties: solution ranging from colorless to light yellow, with a peppermint aroma.

Pharmacotherapeutic group.

Preparations used in throat diseases. Antiseptics. ATC code R02A A.

Pharmacological properties.

Pharmacodynamics.

Lysozyme is a mucopolysaccharide effective against Gram-positive bacteria due to its ability to convert insoluble polysaccharides of the bacterial cell wall into soluble mucoproteins. 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.

Cetylpyridinium is an antiseptic from the group of quaternary ammonium compounds, exerting bactericidal action against both Gram-positive and Gram-negative bacteria. It produces a disinfectant effect on mucous membranes.

Pharmacokinetics.

The drug is applied locally to the mucous membranes of the oral cavity and pharynx. When the solution is swallowed with saliva, a small amount may enter the gastrointestinal tract, and a certain quantity may also be absorbed from the mucous membranes of the mouth and throat.

There are no published literature data on the pharmacokinetics of cetylpyridinium. It is known that only 10–20% of quaternary ammonium compounds are absorbed, while the unabsorbed portion is excreted unchanged in feces.

Clinical characteristics.

Indications.

• Local treatment of acute inflammatory diseases of the oral and pharyngeal mucosa, such as gingivitis, stomatitis, including aphthous stomatitis.
• As part of combination therapy for local treatment of pain, irritation, and inflammation of the throat and pharynx.
• As recommended by a physician during pre- and postoperative periods following tonsillectomy, laryngeal surgery, trauma or abscesses, as well as after tooth extraction.

Contraindications.

• Hypersensitivity to lysozyme hydrochloride, cetylpyridinium chloride, or to any of the excipients of the medicinal product.
• Hypersensitivity to egg protein.
• Children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Do not use simultaneously with other local antiseptics intended for the oral cavity and/or throat.

Special precautions for use

To prevent disruption of the normal oral microflora, the drug should not be used for longer than 5 days. If symptoms of the disease do not resolve within 5 days and/or body temperature remains elevated, medical advice must be sought.

Cases of allergic reactions (hypersensitivity) associated with the use of lysozyme have been reported. If symptoms such as skin rash, itching or redness, facial swelling, swelling of the lips, mouth or tongue, or difficulty breathing and/or swallowing occur, the drug should be discontinued immediately and medical attention sought without delay.

Serious acute hypersensitivity reactions may occur during use of the medicinal product, including urticaria, angioedema (including swelling of the respiratory tract), bronchospasm, circulatory disturbances, and anaphylactic shock. Additionally, 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 the drug must be discontinued at the first sign of symptoms indicating hypersensitivity.

Special warnings regarding excipients contained in the medicinal product:

• Glycerol 85% may cause headache, gastrointestinal disturbances, and diarrhea;
• Propylene glycol may produce symptoms resembling those of alcohol;
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (delayed hypersensitivity reactions are also possible).

Use during pregnancy or breastfeeding

Pregnancy. There are no reliable animal data on the teratogenic effects of the active substances of the medicinal product. Clinical experience regarding the effect of the drug on the fetus is insufficient. Therefore, as a precautionary measure, the use of this medicinal product during pregnancy is not recommended.

Breastfeeding period. As it is unknown whether the components of the drug pass into breast milk, the use of this medicinal product is not recommended for breastfeeding women.

Ability to influence reaction speed when driving or operating machinery

No data are available.

Dosage and Administration.

• The medicinal product is recommended for individual use.
• Before first use, remove the plastic cap from the spray pump, attach the applicator to the spray pump, and press it gently.
• The applicator can be moved sideways and rotated upward at a right angle to the bottle, ensuring proper use of the spray in the oral cavity.
• Before the first application, prime the spray pump by pressing it several times until a uniform spray mist is produced.
• With the mouth widely open, direct the applicator toward the affected area and press the spray pump as many times as indicated in the dosing instructions.
• During the spraying procedure, hold your breath. Do not swallow.
• After using the product, return the applicator downward to lock the spray pump and prevent accidental spraying.

Dosage

One spray delivers 0.20 mL of solution containing 4 mg of lysozyme hydrochloride and 0.3 mg of cetypyridinium chloride.

Adults and children aged 6 years and older

To administer a single dose, press the spray pump 5 times. The procedure may be repeated 3–6 times daily, with a minimum interval of 2 hours between doses.

Children

The medicinal product must not be used in children under 6 years of age.

Overdose.

Cetypyridinium chloride may cause nausea and vomiting due to irritation of the gastrointestinal mucosa.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including anaphylactic reactions, angioedema, anaphylactic shock. These reactions may be accompanied by breathing difficulties and shortness of breath (bronchospasm), as well as decreased blood pressure and feeling of weakness (circulatory complications).

Skin and subcutaneous tissue disorders: rash, pruritus, urticaria.

In addition, isolated cases of serious skin reactions have been reported, such as erythema multiforme, Stevens-Johnson syndrome, which may be life-threatening.

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. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

30 ml in a dark glass bottle with a pump-sprayer and applicator, 1 bottle per cardboard box.

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

Manufacturer/Marketing Authorization Holder: Bosnalijek d.d.

Address of the manufacturer/Marketing Authorization Holder and location of its business operations:

71000, Yukicheva 53, Sarajevo, Bosnia and Herzegovina.