Instructions for Tantum Verde oral spray 45mg 30ml
Composition
active ingredient: benzydamine hydrochloride;
100 ml of oral spray contains 0.15 g of benzydamine hydrochloride;
excipients: ethanol 96%, glycerin, methyl parahydroxybenzoate (E 218), flavoring (menthol), saccharin, sodium bicarbonate, polysorbate 20, purified water.
Dosage form
Oral spray.
Main physicochemical properties: clear colorless liquid with a typical mint flavor.
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 has a local anesthetic effect on the oral mucosa.
Pharmacokinetics.
The fact of absorption through the mucous membrane of the oral cavity and pharynx has been proven by the presence of measurable amounts of benzydamine in human blood plasma. However, this
is insufficient to exert any systemic pharmacological effect. Excretion occurs primarily in the urine, predominantly in the form of inactive metabolites or conjugates.
It has been shown that topical application achieves the accumulation of effective concentrations of benzydamine in inflamed tissues due to its ability to penetrate the mucous membrane.
Indication
Symptomatic treatment of irritations and inflammations 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 drug.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Application features
In cases of sensitivity during long-term use, treatment should be discontinued and a doctor should be consulted to prescribe appropriate treatment.
In some patients, buccal/pharyngeal ulcers may be due to 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 as appropriate.
Benzydamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
The use of the drug may cause bronchospasm in patients with bronchial asthma or with a history of bronchial asthma. Such patients should be warned about this.
For athletes: the use of medicines containing ethyl alcohol 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 breast 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.
Tantum Verde® should not be used 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 operate machinery.
Method of administration and doses
Before use, the nebulizer must be installed.
When you press the pump, an aerosol is formed, which contains 1 dose of spray - 0.17 ml, which corresponds to 0.255 μg of benzydamine hydrochloride.
Dosage
Adults: 4-8 sprays 2-6 times a day.
Children (6-12 years): 4 sprays 2-6 times a day.
Children (4-6 years): 1 spray for every 4 kg of body weight, up to a maximum dose equivalent to 4 sprays 2-6 times daily.
Do not exceed recommended dosages.
Children
The drug can be used in children aged 4 years and over.
Overdose
However, it is known that benzydamine, when taken internally in large doses (hundreds of times higher than the possible doses of this dosage form), especially in children, can cause agitation, convulsions, tremors, nausea, increased sweating, ataxia, vomiting. Such an acute overdose requires immediate gastric lavage, treatment of water and electrolyte imbalance and symptomatic treatment, adequate hydration.
Adverse reactions
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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; frequency unknown - oral hypoesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste changes.
On the part of the immune system: rarely - hypersensitivity reaction; frequency unknown - anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders: very rarely - laryngospasm; frequency unknown - bronchospasm.
Skin and subcutaneous tissue disorders: uncommon - photosensitivity; very rare - angioedema; frequency unknown - rash, itching, urticaria.
Nervous system: frequency unknown - dizziness, headache.
Tantum Verde® contains methyl parahydroxybenzoate, which may cause allergic reactions (also delayed reactions).
Expiration date
4 years.
Storage conditions
Does not require special storage conditions.
Packaging
30 ml of oral spray in a bottle with a nebulizer in a cardboard box.
Vacation category
Without a prescription.
Producer
Aziende Kimike Riunite Angelini Francesco A.K.R.A.F. S.p.A., Italy.
Location of the manufacturer and its business address
Via Vecchio Del Pinocchio, 22 – 60100 Ancona (AN), Italy.
