Decatilen oris

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Decatylen Oris (DecatylenOris)

Composition:

Active ingredient: benzidamine hydrochloride;

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

Excipients: glycerol 85%, ethanol 96%, polyoxyl hydrogenated castor oil, methylparahydroxybenzoate (E 218), sodium saccharin, sodium hydrogen carbonate, cherry flavor, purified water.

Pharmaceutical form. Oral spray.

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

Pharmacotherapeutic group. Agents used 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 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 benzydamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect.

Excretion occurs mainly via the urine, primarily in the form of 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.

Interaction studies 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 medicinal product should be discontinued and medical advice should be sought for appropriate treatment.

In some patients, oral or pharyngeal mucosal ulcers 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 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 eyes.

The medicinal product DecatinenOris 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, considering the thresholds established by certain sports federations.

Use during pregnancy or breastfeeding

There are currently insufficient available data 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 DecatinenOris should not be used during pregnancy or breastfeeding.

Ability to affect 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 DecatilenOris should not be used immediately before eating or drinking. Before the first use, press the spray nozzle several times until a uniform spray is produced. One spray (0.17 mL) contains 0.255 mg of benzidamine hydrochloride.

Before use, it is necessary to:

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 nozzle with a 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 therapeutic effect after 3 days of using the medicinal product, or if symptoms (sore throat and 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): 4 sprays 2–6 times daily (every 1.5–3 hours).

Children. The use of Decatilen Oris is not recommended in children who are unable to hold their breath during spraying.

Elderly patients. There are no special dosage recommendations for elderly patients. Unless otherwise prescribed by a dentist or physician, the dosage indicated for adults should be used.

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

Overdose.

There have been no reports of benzidamine overdose with topical application. However, accidental ingestion of large amounts of benzidamine (> 300 mg), especially in children, may lead to poisoning. Characteristic signs of overdose following oral intake include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, excitement, seizures, 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.

Side effects

Side effects are classified according to their frequency of occurrence: very common (≥ 1/10);
common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 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, hypoaesthesia of the oral cavity; frequency not known – nausea, vomiting, swelling and discoloration of the tongue, taste disturbances.

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 edema; frequency not known – rash, pruritus, urticaria.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the drug. Healthcare professionals are required to report any suspected adverse reactions.

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

Storage conditions.

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

Packaging.

30 ml of oral spray in a bottle with a mechanical pump dispenser and a protective cap; one bottle with an oral applicator supplied in a cardboard box.

Classification.

Over-the-counter (available without prescription).

Manufacturer.

Laboratorimum Sanitatis, S.L.

Manufacturer's address and location of operations.

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