Description
Release form
Topical spray dosage 0.51 mg / dose.
Packing
15 ml (88 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: A01AD02
Pharmacological properties
Benzidamine is a non-steroidal anti-inflammatory drug that belongs to the indazole 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.
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
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.
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
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.
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 violation of metabolic processes and lysosomes of the cell.
Has antifungal activity against Candida albicans.
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 violation of metabolic processes and lysosomes of the cell.
Has antifungal activity against Candida albicans.
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 topicallyand the drug is well absorbed through the mucous membranes and penetrates into the inflamed tissue, is found in the blood plasma in an amount insufficient to produce systemic effects. Excretion of the drug occurs mainly by the kidneys in the form of inactive metabolites.
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, mucous tonsillitis shells 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
-periodontal disease.
For infectious and inflammatory diseases requiring systemic treatment, the use of Tantum ® Verde Forte as part of combination therapy is necessary.
Contraindications
Hypersensitivity to benzidamine or other components of the drug.
Children under 18 years old.
Precautions
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including a history of).
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation (breastfeeding) is not recommended due to insufficient clinical data.
Special instructions
Hypersensitivity reactions may occur with Tantum ® Verde Forte. In this case, it is recommended to discontinue treatment and consult a doctor to prescribe appropriate therapy.
If there is an ulcerative lesion of the mucous membrane of the oropharynx, the patient should consult a doctor if symptoms persist for more than three days.
The use of Tantum ® Verde Forte is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
The drug Tantum ® Verde Forte 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 Forte contains methyl parahydroxybenzoate, which can cause allergic reactions.
Effect on the ability to drive vehicles and control mechanisms
The drug does not affect the ability to drive vehicles and other activities that require increased attention.
Composition of
per 100 ml topical spray dosed 0.51 mg / dose:
Active ingredient:
benzidamine hydrochloride 0.30 g
Auxiliary components:
glycerol 5.0 g,
ethanol 96% 8.0 g ,
macrogol,
glyceryl hydroxystearate 1.5 g,
menthol flavoring (flavoring) 0.5 g,
methyl parahydroxybenzoate 0.1 g,
sodium saccharin 0.07 g,
purified water up to 100 ml.
With one press of the pump, approximately 0.17 g of the drug is released, which corresponds to 0.51 mg of benzidamine hydrochloride.
Dosage and administration
Topical spray dosed 0.51 mg / dose: Adults are prescribed 2-4 doses 2-6 times a day.
To use the spray: lift the cannula, insert it into the oral cavity and direct it to the area of inflammation, press the cap (marked by an arrow).
Benzidamine adheres to the mucous membrane and, due to this, gives a lasting effect. In this regard, the drug should be used after meals.
If you need to use the drug for more than 7 days, you need to consult a doctor.
If after treatment no improvement has occurred or new symptoms appear, you should consult your 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.
Side effects of
Classification of the incidence of side effects of the World Health Organization
(WHO):
very often -? 1/10
often – from? 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.
Local reactions: rarely – dryness, burning in the oral cavity frequency is unknown – a feeling of numbness in the oral cavity.
Allergic reactions:
infrequently
– photosensitivity
rarely
– hypersensitivity reactions, skin rash, skin itching very rarely – angioedema, laryngospasm frequency unknown – anaphylactic reaction.
If any of the side effects listed in the instructions get worse, or
noted other side effects not listed in the instructions, you should immediately inform your doctor.
Drug Interactions
No clinically significant interaction of the drug Tantum ® Verde Forte with other drugs.
Overdose
There have been no reports of overdoses of Tantum ® Verde Forte at this time.
An overdose is unlikely to occur when administered in accordance with the instructions for use.
The following symptoms are possible by ingestion of the drug: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression. Antidote not known. In case of overdose, gastric lavage and symptomatic treatment are recommended.
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
Possible product names
Tantum Verde forte 15ml (88 doses) spray d / local approx. dosing 0.51 mg / dose Fl. X1
Tantum Verde Forte aerosol, 15 ml
TANTUM VERDE FORTE SPR. D / PLACE. NOTE DOSE. FL 15ML
TANTUM VERDE FORTE SPRAY 0.51MG / DOSE 88DOSE 15ML
Tantum Verde forte spray for local use dosed 15 ml
