T-sept®
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT T-Sept® (T-Sept®)
Composition:
Active substance: benzidamine hydrochloride;
1 tablet contains 3 mg of benzidamine hydrochloride;
Excipients: mannitol (E 421), citric acid, hypromellose, aspartame (E 951), flavouring agent (mint), patent blue V dye (E 131), quinoline yellow dye (E 104), magnesium stearate.
Pharmaceutical form. Effervescent tablets for oral resorption.
Main physicochemical characteristics: green, round, biconvex tablets with a marbled surface and mint flavour.
Pharmacotherapeutic group.
Agents used in dentistry. Other agents for local use in the oral cavity. ATC code A01AD02.
Pharmacological Properties.
Pharmacodynamics.
Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.
Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic effects on the mucous membranes of the oral cavity.
Pharmacokinetics.
Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by measurable amounts of benzidamine in human plasma. However, these concentrations are too low to produce any systemic pharmacological effect.
Excretion occurs mainly via the urine, primarily in the form of inactive metabolites or conjugated compounds.
With local application, benzidamine accumulates in inflamed tissues, where effective concentrations are achieved due to its ability to penetrate through the mucous membrane.
Clinical characteristics.
Indications.
Symptomatic treatment of pain, irritation, and inflammation of the oropharynx.
Contraindications.
Hypersensitivity to the active substance or to other components of the medicinal product.
Interaction with other medicinal products and other forms of interactions.
Interaction studies have not been conducted.
Special precautions for use
Oral mucosal ulcers in some patients may be caused by serious pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop elevated body temperature or other new symptoms, should seek medical advice from a physician or, where appropriate, a dentist.
The use of the drug may cause allergic reactions. If such symptoms occur, the drug should be discontinued and medical advice should be sought regarding appropriate therapy.
Benzydamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
In patients with bronchial asthma, including a history of asthma, the drug may provoke bronchospasm. These patients should use the drug with caution.
This medicinal product contains aspartame, a source of phenylalanine (E 951), which may be harmful to patients with phenylketonuria.
This medicinal product 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 may have negative effects on activity and attention in children.
Use during pregnancy or breastfeeding.
There are currently insufficient adequate data on the use of benzydamine in pregnant or breastfeeding women. The ability of this agent to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding the effect of this agent on pregnancy and lactation. There are no data on the potential risk during pregnancy or breastfeeding.
The use of T-Sept® is not recommended during pregnancy and breastfeeding.
Ability to influence reaction rate when driving or operating machinery.
When used at recommended doses, this medicinal product has no effect on the ability to drive or operate machinery.
Method of Administration and Dosage
The tablets should be slowly dissolved in the mouth. They should not be chewed or swallowed.
Adults and children aged 6 years and older: 1 tablet 3 times daily.
The treatment course should not exceed 7 days.
Children.
This medicinal form is intended for children aged 6 years and older.
Children aged 6–11 years should use this medicinal product under adult supervision.
Overdose.
There have been no reports of benzidamine overdose with topical administration. However, it is known that benzidamine, when ingested in large amounts (hundreds of times higher than the possible doses of this medicinal form), particularly in children, may cause excitement, convulsions, tremor, nausea, increased sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalances, symptomatic therapy, and adequate hydration.
Adverse Reactions
Undesirable effects are classified by frequency of occurrence as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from available data).
Gastrointestinal disorders:
Rare – burning sensation in the mouth, dry mouth;
Frequency not known – oral hypoaesthesia.
Immune system disorders:
Frequency not known – anaphylactic reaction, hypersensitivity reaction.
Respiratory, thoracic and mediastinal disorders:
Very rare – laryngospasm.
Skin and subcutaneous tissue disorders:
Uncommon – photosensitivity;
Very rare – angioneurotic edema.
Shelf Life.
2 years.
Storage Conditions.
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of the reach and sight of children.
Packaging.
10 chewable tablets per blister, pack sizes of 10 (10x1) and 20 (10x2) in a cardboard box.
Supply Category.
Over-the-counter (without prescription).
Manufacturer.
ICN Polfa Rzeszow S.A.
ICN Polfa Rzeszow S.A.
Manufacturer's Address and Place of Business.
35-959 Rzeszów, Przemysłowa 2, Poland.
2 Przemyslowa Street, 35-959 Rzeszów, Poland.
Marketing Authorisation Holder.
Amaxa LTD.
Amaxa LTD.
Address of Marketing Authorisation Holder.
31 John Islip Street, London SW1P 4FE, United Kingdom.
31 John Islip Street, London SW1P 4FE, United Kingdom.