Deftoxil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEFTOCYL (DEFTOCYL)

Composition:

Active substance: benzidamine hydrochloride;

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

Excipients: saccharin, sodium bicarbonate, polysorbate 20, mint flavour, methyl parahydroxybenzoate (E 218), glycerol, ethanol 96%, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colourless liquid with a characteristic odour.

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

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

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

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

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via the urine, mainly as inactive metabolites or conjugated compounds.

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

Clinical characteristics.

Indications. Use for 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 interaction. Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought for appropriate management.

In some patients, ulcers of the buccal mucosa/pharynx may be associated with serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should consult a physician or dentist, as appropriate.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

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 result in a positive anti-doping test, depending on the thresholds 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

There are currently insufficient adequate data available on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product is excreted in human milk. Animal studies are insufficient to draw conclusions regarding the use of this medicinal product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Deftozil should not be used during pregnancy or breastfeeding.

Effect on ability to drive and use machines

When used at the recommended doses, this medicinal product has no influence on the ability to drive vehicles 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 body weight, up to a maximum dose equivalent to 4 sprays, 2–6 times daily.

Do not exceed the recommended dosages.

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

Overdose.

There have been no reports of benzidamine overdose with topical administration.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning is possible, especially in children. Characteristic signs of overdose following ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (such as dizziness, hallucinations, excitement, seizures, tremor, excessive 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 adverse reactions by system organ classes and frequency.

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 grouping, adverse reactions are listed in order of decreasing severity.

Reporting of suspected adverse reactions.

Reporting of adverse reactions after marketing authorization of a medicinal product is of great importance. It enables ongoing 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 Information System for Pharmacovigilance 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 and sight of children.

Packaging. 30 ml in a polyethylene container with a cap, supplied with a nebulizer device, in a cardboard carton.

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

Manufacturer. Ukrainian-Spanish joint venture "Sperko Ukraine".

Manufacturer's address and place of business. 25, 600-richchia Street, Vinnytsia, Ukraine, 21027.