Instructions for T-sept oral spray 1.5 mg bottle 30 ml
Composition
active ingredient: benzydamine hydrochloride;
1 ml of solution contains 1.5 mg of benzydamine hydrochloride;
excipients: methyl parahydroxybenzoate (E 218), sodium cyclamate, sodium bicarbonate, glycerin, polysorbate 80, ethanol 96%, peppermint flavor, concentrated phosphoric acid, purified water.
Dosage form
Oral spray, solution.
Main physicochemical properties: transparent colorless solution with a characteristic 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 trials, 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 anti-inflammatory and local analgesic effects, and has a local anesthetic effect on the oral mucosa.
Pharmacokinetics.
Absorption through the oral and pharyngeal mucosa has been demonstrated by the presence of measurable amounts of benzydamine in human plasma. However, this is not sufficient to demonstrate any systemic pharmacological effect.
Excretion occurs mainly in the urine, mainly in the form of inactive metabolites or conjugated compounds.
When applied topically, an effective concentration of benzydamine is achieved in inflamed tissues due to its ability to penetrate the mucous membrane.
Indication
Symptomatic treatment of irritation and inflammation of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.
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
Avoid contact with eyes.
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.
The use of the drug may cause the development of allergies. If such symptoms occur, it is necessary to stop using the drug and consult a doctor for appropriate therapy.
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 a history of bronchial asthma. Such patients should be warned about this.
T-Sept® contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (including delayed reactions), rarely bronchospasm.
This medicinal product contains 81.40 mg of ethyl alcohol per 1 ml, equivalent to 13.84 mg per 0.17 ml (per spray). The amount of alcohol per spray (0.17 ml) of this medicinal product corresponds to less than 0.4 ml of beer or 0.2 ml of wine. The small amount of alcohol in this medicinal product will not have a noticeable effect on the patient.
This medicine contains less than 1 mmol sodium (23 mg) per spray (0.17 ml), i.e. essentially 'sodium-free'.
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.
Use during pregnancy or breastfeeding
There are currently no adequate data available on the use of benzydamine in pregnant or breast-feeding women. The ability of this agent to pass into breast milk has not been studied. Animal data are insufficient to draw any conclusions regarding the effects of this agent during pregnancy or breast-feeding. The potential risk to humans is unknown.
The drug should not be used during pregnancy or 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 or use other mechanisms.
Method of administration and doses
When you press the pump, an aerosol is formed, which contains 1 dose of spray - 0.17 ml, which corresponds to 0.255 mg of benzydamine hydrochloride.
Before use, it is necessary to correctly position the spray device for the spray:
2) if the medicine is used for the first time, press the spray device with your thumb or index finger, holding the bottle in an upright position until the medicine appears;
3) direct the end of the spray device into the oral cavity and press on the device from above
Dosage
Adults: 4-8 sprays 2-6 times a day.
Children (6-12 years): 4 sprays 2-6 times a day.
Children (4-6 years): 1 spray for every 4 kg of body weight, up to a maximum dose equivalent to 4 sprays 2-6 times daily.
Do not exceed recommended dosages.
Children
The drug can be used in children aged 4 years and over.
Overdose
Only in the case of accidental ingestion of a large dose of benzydamine (>300 mg) is intoxication of the body possible.
Symptoms associated with benzydamine overdose are predominantly gastrointestinal and central nervous system symptoms. The most common gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophagitis. Central nervous system symptoms include dizziness, hallucinations, agitation, nervousness and irritability.
In case of acute overdose, only symptomatic treatment is possible. Patients should be closely monitored and supportive treatment should be administered. Adequate hydration should be maintained.
Side effects
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions are classified according to their 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: frequency unknown - anaphylactic reaction, hypersensitivity 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.
T-Sept® contains methyl parahydroxybenzoate, which may cause allergic reactions (also delayed reactions).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 ml of spray in a bottle with a spray device, No. 1 in a cardboard box.
Vacation category
Without a prescription.
Producer
ICN Polfa Rzeszow SA
ICN Polfa Rzeszow S.A.
Address
31 John Islip Street, London SW1P 4FE, United Kingdom.
31 John Islip Street, London SW1P 4FE, United Kingdom.
Applicant
Amaxa LTD.
Amaxa LTD.
