Lortum

INSTRUCTIONS for medical use of the medicinal product LORTUM (LORTUM)

Composition:

Active substance: benzidamine hydrochloride;

1 ml of oral spray contains 1.5 mg of benzidamine hydrochloride;

Excipients: saccharin, sodium hydrocarbonate, polysorbate 20, "Mint" flavouring, methylparahydroxybenzoate (E 218), glycerol, 96% ethanol, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: clear, colourless liquid with a characteristic smell and taste of mint.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local application in the oral cavity.

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics. Benzydamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzydamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics. Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable concentrations of benzydamine in human plasma. However, these concentrations are insufficient to produce any systemic pharmacological effect. Excretion occurs mainly via the urine, primarily in the form of inactive metabolites or conjugated compounds.

It has been shown that with local application, an effective concentration of benzydamine accumulates in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications. Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.

Contraindications. Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interactions. Interaction studies have not been conducted.

Special precautions for use.

If hypersensitivity occurs during prolonged use, treatment should be discontinued and a physician should be consulted for appropriate management.

In some patients, oral/pharyngeal mucosal ulcers may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should consult a general practitioner or, where appropriate, a dentist.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

This medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Athletes should be aware: the use of medicinal products containing ethanol may lead to a positive anti-doping test result, depending on the limits established by certain sports federations.

This medicinal product contains methylparahydroxybenzoate (methylparaben), which may cause allergic reactions (possibly delayed), and in rare cases, bronchospasm.

Use during pregnancy or breastfeeding.

Pregnancy

There are no clinical data on the use of benzidamine during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiopulmonary and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both mother and child, and onset of labor may be delayed.

It is unknown whether the systemic exposure to benzidamine achieved after local application could be harmful to the embryo/fetus.

Therefore, benzidamine should not be used during pregnancy unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Breastfeeding period

Currently, there are no adequate data available on the use of benzidamine in breastfeeding women. The ability of this medicinal product to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding the use of this medicinal product during lactation. The potential risk to humans is unknown.

The medicinal product LORTUM should not be used during breastfeeding.

Effect on ability to drive and use machines. When used at recommended doses, this medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

Before use, the spray device must be attached to the medicinal container.

Pressing the spray device produces a spray containing 1 dose — 0.17 ml, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosing.

Adults: 4–8 sprays 2–6 times daily.

Children (6–12 years): 4 sprays 2–6 times daily.

Children (4–6 years): 1 spray per 4 kg of body weight, up to a maximum dose equivalent to 4 sprays, 2–6 times daily.

Do not exceed the recommended dosage.

Children. The medicinal product can be used in children aged 4 years and older.

Overdose. There have been no reports of overdose with topical use of benzidamine.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning may occur, especially in children. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitation, seizures, tremor, increased sweating, ataxia, anxiety, and irritability). Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions

The table below lists the adverse reactions of the medicinal product by organ systems.

The frequency of adverse reactions is classified as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data). Within each frequency group, adverse effects are listed in order of decreasing severity.

Reporting of suspected adverse reactions

Reporting of adverse reactions following registration of a medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging. 30 ml in a polyethylene container with cap and nozzle, supplied with a nebulizer device, in a cardboard box.

Availability category. Over-the-counter.

Manufacturer. Joint Ukrainian-Spanish enterprise "Sperko Ukraine".

Manufacturer's address and location of operations. 25, 600-richchia St., Vinnytsia, 21027, Ukraine.