Instructions Forteza oral solution 0.15% bottle 120 ml
Composition
active ingredient: benzydamine hydrochloride;
15 ml of solution contains 22.5 mg of benzydamine hydrochloride;
excipients: sodium saccharin, ethanol 96%, methylparaben (E 218), glycerin, polysorbate 20, mint essence, quinoline yellow (E 104), patent blue V (E 131), purified water.
Dosage form
Oral solution.
Main physicochemical properties: green transparent liquid with a minty odor.
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, when applied topically, benzydamine acts as a disinfectant, exerting a local anesthetic effect on the oral mucosa.
Pharmacokinetics
The effectiveness of benzydamine when applied topically is due to its ability to penetrate the epithelial layer and reach effective concentrations in inflamed tissues.
When applied topically at the indicated concentration, benzydamine is absorbed by the mucous membrane, however, its concentration in the blood plasma is so low that it cannot exert any pharmacological effect.
Benzydamine is excreted from the body mainly in the urine in the form of inactive metabolites or conjugation products.
Indication
Symptomatic treatment:
pain caused by gingivitis, stomatitis, pharyngitis; irritations and inflammations of the oropharynx; in dentistry after tooth extraction or for preventive purposes.
Contraindication
Hypersensitivity to the active substance or to any 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 NSAIDs.
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.
Forteza is used for oral administration without dilution. The solution should not be swallowed after use, but should be spit out. If the patient complains of burning or tingling, it is recommended to dilute the drug (see the section "Method of administration and dosage").
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.
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.
Forteza oral solution should not be used during pregnancy or breastfeeding.
Method of administration and doses
Use only for rinsing the mouth. Do not exceed the recommended dose.
Adults and children over 12 years of age should rinse their mouth for 20-30 seconds using one measuring cap (15 ml) of the rinse solution. Then spit out the liquid without swallowing it. The rinse dose (15 ml) can be diluted with the same amount of water if necessary.
Repeat the procedure 2-3 times at intervals of 3-4 hours, unless the doctor has advised a different regimen. If necessary, the number of rinses can be increased to 5.
The duration of treatment is determined by the doctor individually. It is recommended not to use the drug for more than 7 days without consulting a doctor.
The drug should not be used in children under 12 years of age due to the possibility of swallowing the solution while rinsing the mouth.
Overdose
There have been no reports of overdose with topical benzydamine.
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 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.
Forteza oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in a place protected from light and out of the reach of children.
Packaging
120 ml of solution in a glass bottle. 1 bottle together with a measuring cap in a cardboard box.
Vacation category
Without a prescription.
Producer
ABDI IBRAHIM Ilach Sanai ve Tijaret A.S.
Location of the manufacturer and its business address
Orhan Gazi Mahallesi, Tunç Caddesi No. 3, Esenyurt, Istanbul, Turkey.
