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According to ATC classification of drugs, Lysobact COMPLETE Spray® (belongs to the group of drugs with an effect on the respiratory system „Preparations for treatment of throat diseases, antiseptic“ with the accompanying ATC code: R02AA20. Combined drug, the effect of which is due to its constituent components. Lysozyme hydrochloride is a mucopolysaccharide, it destroys (lyses) bacterial cell walls by hydrolysis of peptidoglycans (in particular, murein) of the bacterial cell wall. It is active against gram-positive, some gram-negative bacteria, viruses and fungi. It possesses local antiinflammatory effect and increases nonspecific resistance of the body. Cetylpyridinium chloride is a quaternary ammonium compound with bactericidal action against gram-positive and gram-negative bacteria. In addition, cetylpyridinium exerts a disinfectant effect on the mucosa. It has a variable antifungal activity, effective against some viruses. Cetylpyridinium chloride is almost not absorbed through the mucosa of the oral cavity. Lidocaine is an amide-type local anesthetic. The mechanism of local anesthetic effect is due to stabilization of the neuronal membrane, reduction of its permeability for sodium ions, which prevents the development of an action potential and nerve impulse propagation. Lidocaine is effective for all types of local anesthesia. Lidocaine expands blood vessels. It does not irritate the tissues.  Pharmacokinetic properties Lysobact COMPLETE Spray® is applied topically, with a local effect in the throat area. By swallowing, small quantities of the drug may enter the digestive system, whereas a portion is absorbed through oral or pharyngeal mucosa. Lidocaine is rapidly absorbed through oral mucosal membrane, gastrointestinal tract, or through damaged skin. The absorption through undamaged skin is poor. Presystemic metabolism is extensive, and bioavailability after oral administration is only about 35%. After absorption, lidocaine is rapidly distributed to all body tissues. It passes placenta and blood-brain barrier. Around 65% of the drug is bound to plasma proteins. Plasma half-life totals 1,6 hours. Lidocaine is extensively metabolized in the liver. Any change in the liver function or hepatic blood flow can have a significant effect on the pharmacokinetics and dosage needs. Hepatic metabolism is fast. Around 90% of the administered dose is dealkalized in the forms of monoethylglycinexylidide (MEGX) and glycine xylidide toxicity (GX), both of which can contribute to the therapeutic and toxic effect of lidocaine. Further metabolizing is performed, and metabolites are excreted via urine with less than 10% in the form of unchanged lidocaine. There is no literature data about cetylpyridinium chloride pharmacokinetics. It is known that quaternary ammonia compounds are poorly absorbed, only 10 - 20 %, and the unabsorbed portion is excreted unchanged via faeces.

1 ml of Lysobact COMPLETE Spray® contains: Lysozyme hydrochloride 20.00 mg (corresponding to 800 000 FIP U [International Pharmaceutical Federation units]) Cetylpyridinium chloride 1.50 mg Lidocaine hydrochloride 0.50 mg

Infectious and inflammatory diseases of the mouth and throat: Local treatment of acute inflammatory diseases of the mouth cavity and throat mucosa such as gingivitis (gum disease), stomatitis (inflammation of the mouth cavity mucosa) and aphthae (small wounds on the mouth mucosa). Supporting complex therapy in sore throat and painful swallowing, inflammation of the pharyngitis and the laryngitis. Upon the doctor's recommendation in the preoperative and postoperative periods with tonsillectomy, surgical interventions on the larynx, traumas and abscesses, and after extraction of the tooth

Hypersensitivity to lysozyme hydrochloride, cetylpyridinium chloride, lidocaine hydrochloride and other amide-type anaesthetics, or to any of the excipients. Hypersensitivity to egg white. Children under 6 years of age.

Undesirable effects are classified by system organ class, as well as by the frequency of their occurrence that is defined as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/ 10,000), unknown (cannot be estimated based on available data). Rare: allergic reactions such as anaphylactic shock, Quincke's edema and local hypersensitivity reactions. In extremely rare cases, the use of local anesthetics may be accompanied by allergic reactions. Hypersensitivity reactions to lidocaine hydrochloride after topical application were manifested in the form of localized edema, minor difficulty in breathing or in the form of generalized rash. Unknown: allergic reactions including allergic oedema, skin rush, urticaria, bronchoconstriction and circulatory complications. Furthermore, isolated cases of severe skin reactions such as multiform erythema and StevensJohnson syndrome have been reported. Gastrointestinal disorders occur rarely in the form of irritation of the oral mucosa and are mainly associated with administration of doses higher than the recommended dose

Although numerous interactions of lidocaine with other drugs are theoretically possible, in this case they probably should not have a clinical importance given that Lysobact COMPLETE Spray® is topically applied. Concomitant administration with drugs reducing hepatic blood flow (e.g. propranolol, cimetidine), may reduce lidocaine clearance. Long-term administration with drugs inducing microsomal enzymes whereby drug metabolizing takes place (e.g. phenytoin, barbiturates), may require an increase in the lidocaine dose. Depressing effects of lidocaine on the heart are added to the effects of beta blockers and other antiarrhythmics (e.g. mexiletin). Hypokalaemia caused by acetazolamide, „loop“ diuretics and thiazides, may antagonize the effect of lidocaine. During the use of Lysobact COMPLETE Spray® the patients must not concomitantly use other local antiseptics for oral and/or throat disinfection.  Cetylpyridinium chloride may cause nausea and vomiting due to irritation of the gastrointestinal mucosa. Treatment Lidocaine overdose treatment consists of providing adequate ventilation and stopping convulsions. The ventilation should be maintained with oxygen through assisted or controlled respiration, as needed. Convulsions can be treated with thiopentone, dizepam or succinylcholine. As succinylcholine is going to stop respiration, it should be used only if the clinician is capable of performing endotracheal intubation and maintain medical control of the patient who is temporarily completely paralyzed. If ventricular fibrillation or cardiac arrest occur, an efficient cardiovascular reanimation should be included. Adrenalin in repeated doses and sodium bicarbonate should be used as soon as possible.

Signs and symptoms The application of topical anaesthetics on oral mucosa may impede swallowing and thus increase the danger of aspirating food in the respiratory tract. Therefore, an overdose with Lysobact COMPLETE Spray® may produce a slight risk of an excessive local anaesthetic effect in the glottis region, which consequently may result in decrease of the swallowing reflex control. Extremely high concentrations of lidocaine in the blood may cause effects on the central nervous and /or cardiovascular system. Early CNS effects may consist of nervousness, vertigo, tinnitus, nistagmus, agitation, excitation, paraesthesia, blurred vision, nausea, vomiting and tremor which may progress to medullar depression, as well as tonic and clonic convulsions. Cardiovascular reactions have depressing properties and are manifested as hypotension, myocardial depression, bradycardia and potential cardiac arrest. Although bioavailability of lidocaine is low, it can be sufficient to lead to a significant toxicity when the drug is swallowed. CNS toxicity, convulsions and death have been reported after ingestion of topical preparations. However, in the case of Lysobact COMPLETE Spray® , more than one litre of spray should be swallowed to achieve the quantity of lidocaine (0.5 g or more) sufficient to produce significant toxicity

It is recommended that the drug be used by only one patient. Before first use, the plastic cap should be taken off from the spray pump. After that, the spray applicator should be placed on the spray pump by light pressure. The applicator can move sideways and ensures correct application of the spray in the oral mucosa. The applicator should be turned upwards, at a right angle from the bottle. Before first application of the spray, the spray pump should be first pressed several times until the spraying becomes uniform. Wide open the mouth, direct the applicator toward affected area and press the spray pump as many times as indicated in the drug dosage. Hold the breath during spraying. Do not swallow. After applying the drug, the applicator should be turned downwards, which blocks the spraying. Dosage Adult patients and children above 6 years of age For a single dose, the spray pump should be pressed five times. The procedure can be repeated 3- 6 times a day, with minimum 2 h intervals between dosages. One press of the spray pump releases 0.20 ml of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridinium chloride and 0.1 mg lidocaine hydrochloride. Children under 6 years of age Lysobact COMPLETE Spray® (20 + 1.5 + 0.5) mg/ml oromucosal spray, solution is not intended for use in children under 6 years of age.  Pregnancy Clinical experience related to the effects of the drug on the foetus is insufficient. Therefore, as a precaution measure it is not recommended to use the drug during pregnancy. Lactation Due to the lack of data on the excretion of the product into breast milk, it is not recommended to use this drug during lactation period.

Do not store above 25°C. Do not freeze.