Description
Release form
Topical spray dosed 0.255mg / dose.
Packaging
– 30 ml (176 doses) of a solution in a white polyethylene bottle, equipped with a pump and pressure device with a folding cannula.
– 1 bottle along with instructions for use are placed in a cardboard box.
Pharmacological action of
Pharmacotherapeutic group: non-steroidal anti-inflammatory drug
ATX code: 01AD02
Pharmacological properties of
Pharmacodynamics
Benzidamine is a non-steroidal anti-inflammatory drug in the group of. 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 oral membranes (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
Infectious and inflammatory diseases requiring systemic treatment, it is necessary to use Tantum ® Verde as part of combination therapy.
Contraindications
– hypersensitivity to benzidamine or other components of the drug
– children under 3 years of age
Precautions
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (bronchial asthma).
Special instructions
Hypersensitivity reactions may occur with Tantum Verde. 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 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.
Impact on the ability to drive vehicles, mechanisms
Does not affect the ability to drive vehicles and work with mechanisms.
Composition
Per 100 ml topical spray, dosed 0.255 mg / dose.
Active ingredient:
benzidamine hydrochloride – 0.15 g
Excipients:
ethanol 96% 10.0 ml,
glycerol 5.00 g,
methyl parahydroxybenzoate 0.100 g,
flavor menthol 30 g 0.024 g,
sodium bicarbonate 0.011 g,
polysorbate 20 0.005 g,
purified water qs to 100 ml.
Dosage and administration
Topical spray dosed 0.255 mg / dose:
Locally, after meals. One dose (one injection) corresponds to 0.255 mg of benzidamine.
Adults (including elderly patients) and children over 12 years of age with 4-8 injections 2-6 times a day. Children from 6 to 12 years old – 4 injections 2-6 times a day. Children from 3 to 6 years, 1 injection for every 4 kg of body weight, but not more than 4 injections (maximum single dose) 2-6 times a day. Do not exceed recommended dose.
1. Turn the cannula (white tube) to the upright to vial position.
2. Insert a cannula into your mouth and direct it to sore spots in your mouth or throat.
3. Press the dosing pump on the top of the bottle as many times as the doses prescribed. One click corresponds to one dose. Hold your breath while injecting.
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 application and at the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
Side effects
Classification of the incidence of side effects of the World Health Organization (WHO):
very often -? 1/10 srdlp 1/100 to
infrequently – from? 1/1000 to
rarely – from? 1/10000 to
very rarely –
frequency is unknown – cannot be estimated based on available data.
In each group, unwanted effects are presented in decreasing order of severity.
Local reactions: rarely – dry mouth, burning sensation in the oral cavity frequency unknown – numbness in the oral cavity.
Allergic reactions: infrequently – photosensitivity rarely – hypersensitivity reactions. skin rash, itching very rarely – angioedema, laryngospasm frequency unknown – anaphylactic reactions.
If any of the side effects indicated in the instructions are aggravated, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor.
Drug Interactions
No drug interaction studies have been conducted.
Overdose
There have been no reports of overdoses of Tantum ® Verde at this time.
Symptoms:
is unlikely to be overdosed when used in accordance with 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 rinsing the stomach 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
without prescription
dosage form
spray for oral cavity
Possible product names
TANTUM VERDE 0.000255 / DOSE 30ML SPRAY
Tantum Verde 0.255mg / dose 30ml spray
Tantum Verde 30ml (176dose) spray d / local approx. dosing 0.255mg / dose Fl. X1
TANTUM VERDE 30ML. SPRAY
Tantum Verde aerosol, 30 ml
Aziende Kimiko Riunite Angelini Francesco A.K.P.A., Italy
