Loraseiv®

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

Composition:

Active substances: lysozyme hydrochloride, pyridoxine hydrochloride;

One effervescent tablet contains lysozyme hydrochloride, recalculated to 100% substance – 20 mg, pyridoxine hydrochloride, recalculated to 100% substance – 10.0 mg;

Excipients: anhydrous lactose, tragacanth, sodium saccharin, vanillin, magnesium stearate.

Pharmaceutical form. Effervescent tablets.

Main physicochemical characteristics: round, white or almost white tablets with a smooth surface.

Pharmacotherapeutic group. Preparations used in case of throat diseases. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

Lysozyme is a mucopolysaccharide effective against Gram-positive bacteria due to conversion of insoluble polysaccharides of the cell wall into soluble mucoproteins. It is also effective against Gram-negative bacteria, viruses, and fungi. Lysozyme exerts local anti-inflammatory activity and enhances non-specific resistance of the body. Pyridoxine provides protective action on the oral mucosa and has anti-aphthous effect.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

Local adjunctive 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, allergy to lysozyme and egg protein.

Interaction with other medicinal products and other types of interactions.

Loraseiv® should not be used simultaneously with other medicinal products containing antiseptics, or when other medicinal products containing pyridoxine hydrochloride are prescribed. Lysozyme enhances the efficacy of antibacterial agents such as penicillin and chloramphenicol.

Isoniazid, penicillamine, pyrazinamide, hydralazine, immunosuppressants, and estrogens (including oral contraceptives containing estrogens) may increase the requirement for pyridoxine, as they act as pyridoxine antagonists 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 product is not intended for prolonged use.

To prevent disruption of the normal oral microflora, the product should not be used for longer than 5 days.

The product contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome should not take this product. 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, medical advice should be sought.

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

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

Given data suggesting a possible increase in gastric acidity with pyridoxine doses exceeding 30 mg/day, the product 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 product 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 product during breastfeeding is not recommended.

Ability to affect performance of skills

Does not affect.

Dosage and Administration.

The medication should be administered to adults and children aged 3 years and older.

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

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

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

The tablets should be slowly dissolved in the mouth, retaining the resulting solution in the oral cavity for some time. The interval between doses should be at least 1 hour. The duration of treatment is 5 days.

Children.

The medication is contraindicated in children under 3 years of age.

Overdose.

Clinically significant adverse effects are not expected following administration of Loraseiv® at doses significantly exceeding the recommended ones.

The medication 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 (Quincke's edema).

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 via the manufacturer's website – www.arterium.ua, by leaving a message in the Pharmacovigilance section.

Shelf life. 2 years.

Storage conditions. In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets per blister, 1 or 3 blisters per carton.

Dispensing category. Over-the-counter.

Manufacturer

JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksaganskoho Street, Kyiv, 01032, Ukraine.