Instructions for Decatilen Oris oral spray 1.5 mg/ml bottle 30 ml
Composition
active ingredient: benzydamine hydrochloride;
1 ml of oral spray contains benzydamine hydrochloride 1.5 mg;
excipients: glycerin 85%, ethanol 96%, polyethoxylated hydrogenated castor oil, methyl parahydroxybenzoate (E 218), sodium saccharin, sodium bicarbonate, cherry flavoring, purified water.
Dosage form
Oral spray.
Main physicochemical properties: transparent colorless solution with cherry taste and smell.
Pharmacotherapeutic group
Means for use in dentistry. Other means for local use in the oral cavity. ATX code A01A D02.
Pharmacological properties
Pharmacodynamics.
Benzydamine is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antiexudative properties.
In clinical studies, benzydamine has been shown to be effective in relieving symptoms associated with localized irritant pathologies in the oral cavity and pharynx. In addition, benzydamine has anti-inflammatory and local analgesic effects, and exhibits a local anesthetic effect on the oral mucosa.
Pharmacokinetics.
Absorption through the oral and pharyngeal mucosa has been demonstrated by the presence of measurable amounts of benzydamine in human plasma. However, this is not sufficient to exert any systemic pharmacological effect.
Excretion occurs mainly in the urine, mainly in the form of inactive metabolites or conjugated compounds.
When applied topically, an effective concentration of benzydamine is achieved in inflamed tissues due to its ability to penetrate the mucous membrane.
Indication
Symptomatic treatment of irritation and inflammation of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.
Contraindication
Hypersensitivity to the active substance or to other components of the medicinal product.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Application features
The use of the drug may cause adverse reactions, in which case its use should be discontinued. In cases of increased sensitivity during long-term use, the drug should be discontinued and a doctor should be consulted for appropriate treatment.
In some patients, oral/pharyngeal ulcers may be symptoms of serious pathological processes. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop a fever or other symptoms, should seek advice from a physician or dentist.
Benzydamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
The use of the drug may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients should be warned about this, and the drug should be used with caution in such cases. Long-term therapy with this drug is not recommended, as it may harm the bacterial flora of the oral cavity.
Avoid contact with eyes.
The drug Decatilen Oris contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed), and in some cases, bronchospasm.
The medicine contains polyethoxylated hydrogenated castor oil, which may cause stomach upset and diarrhea.
This medicine contains a small amount of ethanol (alcohol) - less than 100 mg per 0.5 ml of medicine.
For athletes: the use of medicines containing ethanol may give a positive result in an anti-doping test, taking into account the limits set by some sports federations.
Use during pregnancy or breastfeeding
There are currently no adequate data available on the use of benzydamine in pregnant or breastfeeding women. The ability of this drug to pass into human milk has not been studied. Animal data are insufficient to draw any conclusions regarding the effects of this drug during pregnancy or breastfeeding. The potential risk to humans is unknown.
You should not use Decatilen Oris during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in recommended doses, the drug has no effect on the ability to drive vehicles and work with other mechanisms.
Method of administration and doses
The drug Decatilen Oris should not be used immediately before eating or drinking. Before first use, press the spray head several times until a uniform jet appears. One spray - 0.17 ml contains 0.255 mg of benzydamine hydrochloride.
Before use, you must:
1. lift the applicator;
2. Insert the end of the applicator into the mouth and point it at the area to be treated. Press the spray head with your finger. The patient should hold their breath during spraying. Do not exceed the recommended dose. Continuous treatment should not last more than 7 days. If after 3 days of using the medicine there is no effect or the symptoms (sore throat and mouth) worsen, you should consult a doctor.
Dosage
Adults and children over 12 years of age: 4–8 sprays 2–6 times a day (every 1.5–3 hours).
Children (6–12 years): 4 sprays 2–6 times a day (every 1.5–3 hours).
Children. It is not recommended to use the drug Decatilen Oris in children who cannot hold their breath during the spray.
Elderly patients: There are no special dosage recommendations for elderly patients. Unless otherwise prescribed by a dentist or physician, the doses indicated for adults should be used.
Children
The medicine can be used in children aged 6 years and over.
Overdose
There have been no reports of overdose with benzydamine when applied topically. Accidental ingestion of large amounts of benzydamine (> 300 mg), especially in children, may result in poisoning. Characteristic signs of overdose in the case of internal administration are symptoms from the gastrointestinal tract (most often nausea, vomiting, abdominal pain, esophageal irritation) and the central nervous system (dizziness, hallucinations, agitation, convulsions, tremor, increased sweating, ataxia, anxiety and irritability).
Such an acute overdose requires immediate gastric lavage, correction of water and electrolyte balance disorders and symptomatic treatment, adequate hydration.
Side effects
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 (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available data).
Gastrointestinal: rarely - burning sensation in the mouth, dry mouth, oral hypoesthesia; frequency unknown - nausea, vomiting, swelling and discoloration of the tongue, change in taste.
On the part of the immune system: frequency unknown - hypersensitivity reaction, anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders: very rarely – laryngospasm, bronchospasm.
Skin and subcutaneous tissue disorders: uncommon - photosensitivity; very rare - angioedema; frequency unknown - rash, itching, urticaria.
Nervous system: frequency unknown - dizziness, headache.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions during post-marketing surveillance is very important. This allows monitoring of the benefit-risk balance of medicinal products. Healthcare professionals should report suspected adverse reactions.
Expiration date
3 years. After first opening – 4 weeks.
Storage conditions
The medicine does not require any special storage conditions. Keep out of the reach of children.
Packaging
30 ml of oral spray in a bottle with a mechanical sprayer and a cap that protects the sprayer; 1 bottle complete with an oral applicator in a cardboard box.
Vacation category
Without a prescription.
Producer
Laboratorium Sanitatis, S.L.
Location of the manufacturer and address of its place of business.
C/ Leonardo da Vinci, 11 (Parque Tecnológico de Álava), Mignano, Álava, 01510, Spain.
