Translation of the instructions can be
TONZILEX oral spray
Instruction
For medical use of the medicinal product
Composition:
Active ingredients: hexetidine, choline salicylate, chlorobutanol hemihydrate;
1 ml of solution contains: hexetidine 1 mg, choline salicylate 5 mg, chlorobutanol hemihydrate 2.5 mg;
excipients: sodium saccharin (E 954), polysorbate 20 (E 432), propionic acid (E 280), lemon oil, anise oil, ethanol 96%, purified water.
Dosage form.
Oral spray.
Main physicochemical properties: transparent solution, slightly yellowish in color with a specific aromatic odor.
Pharmacotherapeutic group.
Means used for throat diseases. antiseptics. ATS code r02a a20.
Pharmacological properties.
Pharmacodynamics.
The effect of the drug is due to three active components.
Antibacterial and antifungal activity.
Hexetidine has an antibacterial effect on both gram-positive and gram-negative strains of microorganisms, both aerobes and anaerobes.
It should be noted that on aerobic strains it has a generally bacteriostatic effect, the bactericidal effect is weak. On anaerobic strains hexetidine has a pronounced bactericidal effect. The mechanism of action is a competitive action with thiamine: the structure of hexetidine is similar to the structure of thiamine, which is necessary for the growth of microorganisms.
Anti-inflammatory activity.
Choline salicylate has analgesic, antipyretic and anti-inflammatory effects. It is used to treat diseases of the oral cavity.
Analgesic activity.
Chlorobutanol has an analgesic effect. It can be used, in particular, in otolaryngology (nose drops, rinsing) and in dental practice (applications and irrigation). It can be classically used as an anesthetic.
The active substances are fixed on the mucous membrane of the oral cavity, from where they are gradually released.
Pharmacokinetics.
Didn't study.
Clinical characteristics.
Indication.
Antibacterial and analgesic agent for the local treatment of diseases of the oral mucosa and oropharynx.
Contraindication.
Hypersensitivity to any component of the drug; atrophic pharyngitis; bronchial asthma or any other respiratory diseases associated with existing respiratory hypersensitivity.
Interaction with other drugs and other types of interactions.
Do not use together with preparations containing antiseptics.
Hexetidine can be inactivated by alkaline solutions.
Application features.
When using the drug, do not swallow and avoid contact with eyes, as the drug contains ethanol.
The drug should be used with caution in patients with epilepsy. It may lower the epileptic threshold and cause seizures in children.
Use with caution in patients with a tendency to allergic reactions, including bronchial asthma, especially in patients with an allergy to acetylsalicylic acid.
If signs of hypersensitivity to the drug appear, its use should be discontinued immediately.
Since the drug contains ethanol, it should be administered with caution to patients with liver disease.
Long-term use of the drug is not recommended, as the natural microbial balance of the oral cavity and throat may change, where there is a risk of bacterial and fungal spread.
If general clinical signs of bacterial infection appear, general antibacterial therapy should be prescribed.
If symptoms persist for more than 5 days and/or body temperature is elevated, treatment tactics should be reviewed.
If inflammation increases, treatment with the drug should be discontinued.
Use during pregnancy or breastfeeding.
There are no human studies on the possibility of hexetidine crossing the placenta and being excreted in breast milk, so the drug should not be used during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
The drug contains ethanol. Drivers are not recommended to drive a car for 30 minutes after using the drug.
Method of administration and doses.
Use as a topical agent for irrigation of the oral cavity and oropharynx.
Adults and children over 15 years of age: 1 spray 4-6 times a day.
Children from 6 to 15 years old: 1 spray 2-3 times a day.
The course of treatment is no more than 5 days.
Children.
Do not use in children under 6 years of age.
Overdose.
There have been no reports of overdose.
Alcohol intoxication may occur due to the ethyl alcohol content due to the absorption of a sufficient amount of solution in the oral cavity.
The concentration of hexetidine in the drug is not toxic if the drug is used as directed.
Acute alcohol intoxication is unlikely. If a child swallows a significant dose of the drug, alcohol intoxication may occur due to the ethyl alcohol content.
There have been no cases of excessive use of hexetidine leading to hypersensitivity reactions.
Treatment of overdose is symptomatic, but rarely necessary. If a child swallows the contents of the bottle, seek medical attention immediately. Gastric lavage should be considered within 2 hours of ingestion and measures should be taken to eliminate signs of alcohol intoxication.
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.
From the nervous system: ageusia, dysgeusia, change in taste sensations within 48 hours (the sensation of "sweet" can change to the sensation of "bitter" twice).
Respiratory, thoracic and mediastinal disorders: cough, shortness of breath.
On the part of the digestive system: dry mouth, dysphagia, enlargement of the salivary glands, pain when swallowing. In case of accidental ingestion of the drug, gastrointestinal disorders may occur, primarily nausea and vomiting.
Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).
General disorders and administration site conditions: local reactions - reversible discoloration of teeth and tongue; sensitivity of the mucous membrane, namely - burning, numbness; irritation (soreness, feeling of heat, itching) of the tongue and / or mucous membrane of the oral cavity; decreased sensitivity; paresthesia of the mucous membrane; inflammation; blisters; the appearance of ulcers on the mucous membrane, a feeling of tickling in the throat, swelling at the site of contact, dryness of the mucous membrane of the nose / throat.
Expiration date.
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging.
50 ml in a bottle with a spray pump and a throat nozzle in a cardboard pack.
Vacation category.
Without a prescription.
Producer.
PJSC "Khimpharmzavod" Red Star ".
Location of the manufacturer and address of its place of business.
61010, Ukraine, Kharkiv, 1 Hordienkovska St.
