Tevalor-teva benzydamine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Tevalor-Teva Benzydamine (Tevalor-Teva Benzydamine)

Composition:

Active substance: benzydamine hydrochloride;

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

Excipients: glycerol 85%, ethanol 96%, polyethylene glycol hydrogenated castor oil, methylparahydroxybenzoate (E 218), sodium saccharin, sodium hydrogencarbonate, cherry flavor, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless solution with a cherry taste and odor.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local use 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 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 benzydamine in human plasma. However, the plasma concentrations achieved are insufficient to produce any systemic pharmacological effect.

Excretion occurs primarily via the urine, mainly as inactive metabolites or conjugated compounds.

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 irritation and inflammation 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.

Studies on interaction have not been conducted.

Special precautions for use.

The use of the medicinal product may cause adverse reactions, in which case its use should be discontinued. In cases of increased sensitivity during prolonged use, the use of the medicinal product should be discontinued and medical advice sought for appropriate treatment.

In some patients, ulcers of the oral or pharyngeal mucosa may be symptoms of serious pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should consult a physician or dentist.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

The use of the medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly, and the medicinal product should be used with caution in these cases. Prolonged therapy with this medicinal product is not recommended, as it may adversely affect the bacterial flora of the oral cavity.

Avoid contact with the eyes.

The medicinal product Tevalor-Teva Benzidamine contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed-type), and in rare cases, bronchospasm.

The medicinal product contains hydrogenated polyoxyl castor oil, which may cause gastrointestinal disturbances and diarrhea.

This medicinal product contains a small amount of ethanol (alcohol) – less than 100 mg per 0.5 ml of the medicinal product.

For athletes: the use of medicinal products containing ethanol may result in a positive anti-doping test, depending on the limits established by certain sports federations.

Use during pregnancy or breastfeeding.

Currently, there are insufficient data available on the use of benzidamine in pregnant or breastfeeding women. The ability of this medicinal product to pass into human breast milk has not been studied. Animal studies are insufficient to draw any conclusions regarding the effects of this medicinal product during pregnancy or breastfeeding. The potential risk to humans is unknown.

The medicinal product Tevalor-Teva Benzidamine should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

When used at recommended doses, the medicinal product does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medicinal product Tevalor-Teva Benzidamine should not be used immediately before eating or drinking. Before the first use, press the spray pump several times until a uniform spray is produced. One spray (0.17 mL) contains 0.255 mg of benzidamine hydrochloride.

Before administration:

1. Lift the applicator;
2. Insert the tip of the applicator into the oral cavity and direct it toward the affected area.

Press the spray pump with your finger. The patient should hold their breath during spraying. Do not exceed the recommended dose. Continuous treatment should not last longer than 7 days. If there is no improvement after 3 days of using the medicinal product, or if symptoms (such as sore throat or oral pain) worsen, consult a physician.

Dosage

Adults and children aged 12 years and older: 4–8 sprays 2–6 times daily (every 1.5–3 hours).

Children (6–12 years of age): 4 sprays 2–6 times daily (every 1.5–3 hours).

Children. The use of Tevalor-Teva Benzidamine is not recommended in children who are unable to hold their breath during spraying.

Elderly patients. No specific dosage recommendations are available for elderly patients. Unless otherwise prescribed by a dentist or physician, the dosage recommended for adults should be used.

Children.

The medicinal product may be used in children aged 6 years and older.

Overdose.

There have been no reports of benzidamine overdose following topical application. However, accidental ingestion of large amounts of benzidamine (> 300 mg), particularly in children, may lead to poisoning. Characteristic signs of overdose following oral ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, agitation, convulsions, tremor, excessive sweating, ataxia, anxiety, and irritability).

In cases of acute overdose, immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration are required.

Adverse Reactions

Adverse reactions are classified according to their frequency of occurrence: 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 based on available data).

Gastrointestinal disorders: rare – burning sensation in the mouth, dry mouth, oral hypoaesthesia; frequency not known – nausea, vomiting, swelling and discoloration of the tongue, taste alterations.

Immune system disorders: frequency not known – hypersensitivity reaction, anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders: very rare – laryngospasm, bronchospasm.

Skin and subcutaneous tissue disorders: uncommon – photosensitivity; very rare – angioneurotic oedema; frequency not known – rash, pruritus, urticaria.

Nervous system disorders: frequency not known – dizziness, headache.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions is important after a medicinal product is marketed. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report suspected adverse reactions.

Shelf life. 3 years. After first opening – 4 weeks.

Storage conditions.

This medicinal product does not require special storage conditions. Keep out of the reach of children.

Packaging.

30 ml of oral spray in a bottle with a mechanical pump and a protective cap covering the pump; 1 bottle with an oral applicator in a cardboard box.

Pharmaceutical classification.

Available without prescription.

Manufacturer.

Laboratorios Sanitas, S.L.

Manufacturer's address and place of business.

C/ Leonardo da Vinci, 11 (Parque Tecnológico de Álava), Miñano, Álava, 01510, Spain.