Description
0.1% solution for srd.
Packaging
-120 ml of a solution in a bottle of colorless transparent glass, closed with a screw cap made of polyethylene with a sealing ring made of polyethylene.
– a polypropylene cup with a graduation of 15 and 30 ml is attached to the bottle.
-vial with a graduated glass and instructions for use are placed in a cardboard box.
Pharmacological action of
Pharmacotherapeutic group: non-steroidal anti-inflammatory drug
ATC code: 01AD02
Pharmacological properties of
Pharmacodynamics
Benzidamine is a non-steroidal anti-inflammatory drug belonging to the group. It has an anti-inflammatory and local anesthetic effect, has an antiseptic effect against a wide range of microorganisms.
The mechanism of action of the drug is associated with stabilization of cell membranes and inhibition of prostaglandin synthesis.
Benzidamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic processes and cell lysosomes.
Has antifungal activity against Candida albicans. It causes structural modifications of the cell wall of fungi and their metabolic chains, thus inhibiting their reproduction, which was the basis for the use of benzidamine in inflammatory processes in the oral cavity, including infectious etiology.
Pharmacokinetics
When applied topically, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues, is found in plasma in an amount insufficient to produce systemic effects. Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.
Indications
Symptomatic therapy for pain of inflammatory diseases of the oral cavity and ENT organs (of various etiologies):
-gingivitis, glossitis, stomatitis (including after radiation and chemotherapy)
-pharyngitis, laryngitis, tonsillitis, tonsillitis the shell of the oral cavity (as part of combination therapy)
-calculous inflammation of the salivary glands
-after surgical interventions and injuries (tonsillectomy, jaw fractures)
-after treatment and tooth extraction
-periodontosis
For infectious and inflammatory diseases requiring systemic treatment, the use of Tantum ® Verde as part of combination therapy.
Contraindications
– hypersensitivity to benzidamine or other components of the drug
– children under 12 years old
Precautions
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (e.g.
Special instructions
If a burning sensation occurs when using the solution, the solution should be diluted 2 times with water before adjusting the water level to risks in a graduated glass.
When using the drug Tantum ® Verde, hypersensitivity reactions may develop. In this case, it is recommended to discontinue treatment and consult a doctor to prescribe appropriate therapy.
In a limited number of patients, the presence of ulcers in the throat and oral cavity may indicate
for a more serious pathology. If symptoms persist for more than 3 days, consult a doctor.
The use of Tantum ® Verde is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
The drug Tantum ® Verde should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm in patients with the drug.
Tantum ® Verde contains parahydroxybenzoates, which can cause allergic reactions.
patients, involved in sports: when using preparations containing ethanol, the results of anti-doping tests for the maximum permissible ethanol content in the blood according to the norms established by some sports federations may be positive. Drivers driving vehicles should bear in mind that the drug contains ethanol (1.2 g of 96% alcohol is contained in one dose of the drug (15 ml).
Impact on the ability to drive vehicles, mechanisms
Does not affect the ability to drive vehicles and work with mechanisms.
Composition
Per 100 ml of topical solution 0.15%:
Active ingredient: benzidamine hydrochloride – 0.15 g
Excipients:
ethanol 96% 8.00 g,
glycerol (glycerol) 5.00 g,
methyl parahydroxybenzoate 0.100 g,
menthol flavoring 0.030 g,
saccharin 0.024 g,
sodium bicarbonate 0.011 g,
polysorbate 20 0.005 g,
dye quinoline yellow 70% (E101 blue dye, 0.001% sintent blue ) 0.00033 g,
purified water qs to 100 ml.
Dosage and Administration
Locally, after meals. Adults (including elderly patients) and children from 12 years old use 15 ml of the drug for rinsing the throat or oral cavity (a measuring cup is attached) 2-3 times a day. After rinsing, the solution must be spit out. If a burning sensation occurs when using undiluted solution, the solution should be diluted (for dilution add 15 ml of water to a measuring cup). Do not exceed recommended dose.
Duration of treatment should not exceed 7 days. If after treatment within 7 days there is no improvement or new symptoms appear, it is necessary to consult a doctor.
Use the drug only according to the method of use and at the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
Drug Interactions
No other drug interaction studies have been conducted.
Overdose
There have been no reports of overdoses of Tantum ® Verde at this time.
Symptoms: overdose is unlikely to occur when administered according to the instructions for use. In case of accidental ingestion, the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.
Treatment: symptomatic to cleanse the stomach by causing vomiting or gastric lavage, using a gastric probe (under the supervision of a doctor) to provide medical observation, supportive therapy and necessary hydration. Antidote not known.
Storage Conditions
At a temperature not exceeding 25 ° C, in a dark place.
Keep out of the reach and sight of children!
Shelf life
4 years.
Do not use after expiration date.
Deystvuyushtee substance
benzydamine
Terms and conditions otpuska IZ
pharmacies without a prescription
Kimiko Aziende Riunite Angelini Francesco A.K.R.A., Italy
