Instructions for Tantum Verde mint-flavored lollipops No. 20
Composition
active ingredient: benzydamine hydrochloride;
1 lollipop contains benzydamine hydrochloride 3 mg (equivalent to 2.68 mg of benzydamine);
excipients: isomalt (E 953); aspartame (E 951); levomenthol; citric acid, monohydrate; lemon flavor; mint flavor; quinoline yellow (E 104); indigotine (E 132).
Dosage form
Lollipops.
Main physicochemical properties: green, translucent, square-shaped lollipops with a depression in the middle, with a characteristic mint-lemon flavor.
Pharmacotherapeutic group
Dental products. Other products 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 an anti-inflammatory and local analgesic 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 plasma. Approximately 2 hours after taking a 3 mg lozenge, the maximum concentration of benzydamine in plasma is 37.8 ng/ml, and the AUC value is 367 ng/ml*h. However, these concentrations are too low to produce systemic pharmacological effects.
Excretion occurs mainly in the urine, mainly in the form of inactive metabolites or conjugated compounds.
It has been shown that topical application of benzydamine results in accumulation in inflamed tissues, where effective concentrations are achieved due to its ability to penetrate the epithelial lining.
Indication
Symptomatic treatment of pain, irritation and inflammation of the oropharynx.
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
Benzydamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
In patients with bronchial asthma, including a history of it, the drug may provoke bronchospasm. The drug should be used with caution in such patients.
In some patients, oropharyngeal 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 medical advice (dentist).
This medicine contains aspartame, which is a source of phenylalanine synthesis. It may be dangerous for patients with phenylketonuria.
This medicine contains isomalt and should not be used in patients with rare hereditary problems of fructose intolerance.
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 conclusions about the effects of this drug on pregnancy and lactation. There is no information on the potential risk during pregnancy or breastfeeding.
Tantum Verde® should not be used during pregnancy and 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
Lollipops should be slowly dissolved in the mouth.
Adults and children over 6 years of age: one lollipop 3 times a day.
Lozenges should not be swallowed. Lozenges should not be chewed.
The course of treatment should not exceed 7 days.
Children: This dosage form is used in children aged 6 years and older.
Children aged 6-11 years use this medicine under adult supervision.
Overdose
There have been no reports of overdose with topical benzydamine.
However, it is known that benzydamine, when taken orally in large doses (which are 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 disorders and symptomatic treatment, adequate hydration.
Adverse reactions
Adverse reactions are classified according to frequency of occurrence as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available data).
On the part of the digestive system - rarely: burning sensation in the mouth, dry mouth; frequency unknown: oral hypoesthesia.
Immune system disorders: Rare: hypersensitivity reaction; frequency unknown: anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders: very rare: laryngospasm.
Skin and subcutaneous tissue disorders: uncommon: photosensitivity; very rare: angioedema.
Expiration date
4 years.
Storage conditions
Store the drug at a temperature not exceeding 25°C. The drug must be stored in its original packaging to protect from moisture.
Packaging. Each lollipop is wrapped in waxed paper with the inscription “TANTUM VERDE”, 10 lollipops form a stick, which is wrapped in a polyethylene/paper/aluminum foil wrapper. 2 or 3 sticks are placed in a cardboard pack together with instructions for medical use.
Vacation category
Without a prescription.
Manufacturers
Azienda Quimique Riunite Angelini Francesco A.C.R.A.F. S.p.A. (responsible for secondary packaging, control and batch release);
PIERRE FABRÉ MEDICAMANN PRODUCTION (responsible for the full production cycle).
Location of manufacturers.
Via Vecchio Del Pinocchio, 22 – 60100 Ancona (AN), Italy.
Center for dietary and pharmaceutical products,
Kudett Industrial Zone,
Aignan, 32290, France.
