Instructions for use T-sept lozenges 3 mg No. 20
Composition
active ingredient: benzydamine hydrochloride;
1 tablet contains 3 mg of benzydamine hydrochloride;
excipients: mannitol (E 421), citric acid, hypromellose, aspartame (E 951), flavoring (mint), dye patent blue V (E 131), dye quinoline yellow (E 104), magnesium stearate.
Dosage form
Tablets for resorption.
Main physicochemical properties: round, biconvex tablets of green color with a marble surface, with a mint aroma.
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 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, these concentrations are too low to demonstrate a systemic pharmacological effect.
Excretion occurs mainly in the urine, mainly in the form of inactive metabolites or conjugated compounds.
When applied topically, benzydamine accumulates in inflamed tissues, where effective concentrations are achieved due to its ability to penetrate the mucous membrane.
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
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 advice from a general practitioner 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.
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.
This medicine contains aspartame, which is a source of phenylalanine (E 951). It may be dangerous for patients with phenylketonuria.
This medicine contains the dye patent blue V (E 131), which may cause allergic reactions, and the dye quinoline yellow (E 104), which may cause allergic reactions and have an adverse effect on activity and attention in children.
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.
T-Sept® 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 or use other mechanisms.
Method of administration and doses
The tablets should be slowly dissolved in the mouth. They should not be chewed or swallowed.
Adults and children over 6 years of age: 1 tablet 3 times a day.
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 benzydamine when applied topically. 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 acute overdose requires immediate gastric lavage, treatment of water and electrolyte disorders and symptomatic treatment, adequate hydration.
Side effects
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.
On the part of the immune system: frequency unknown - anaphylactic reaction, hypersensitivity reaction.
Respiratory, thoracic and mediastinal disorders: very rarely - laryngospasm.
Skin and subcutaneous tissue disorders: uncommon - photosensitivity; very rare - angioedema.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
10 lozenges in a blister, No. 10 (10x1) and No. 20 (10x2) in a cardboard box.
Vacation category
Without a prescription.
Producer
ICN Polfa Rzeszow S.A.
ICN Polfa Rzeszow SA
Address
31 John Islip Street, London SW1P 4FE, United Kingdom.
31 John Islip Street, London SW1P 4FE, United Kingdom.
Applicant
Amaxa LTD.
Amaxa LTD.
