Tonsilex

INSTRUCTIONS FOR MEDICAL USE OF MEDICINAL PRODUCT

TONZILEX TONSILEX

Composition:

Active substances: 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.

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: clear solution, slightly yellowish in color, with a characteristic aromatic odor.

Pharmacotherapeutic group. Preparations used in throat diseases. Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The action of the drug is due to its three active components.

Antibacterial and antifungal activity

Hexetidine exerts antibacterial effects against both Gram-positive and Gram-negative microbial strains, as well as against both aerobic and anaerobic organisms.

It has been observed that hexetidine generally produces a bacteriostatic effect on aerobic strains, with weak bactericidal activity. Against anaerobic strains, hexetidine demonstrates pronounced bactericidal activity. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity

Choline salicylate provides analgesic, antipyretic, and anti-inflammatory effects. It can be used for the treatment of oral cavity diseases.

Analgesic activity

Chlorobutanol exerts an analgesic effect. It can be used, in particular, in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and irrigations). It can classically be used as a local anesthetic.

The active substances bind to the oral mucosa, from where they are gradually released.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Antibacterial and analgesic agent for local treatment of diseases of the mucous membrane of the oral cavity and oropharynx.

Contraindications.

• Hypersensitivity to any component of the drug;
• atrophic pharyngitis;
• bronchial asthma or any other respiratory tract diseases associated with existing airway hypersensitivity.

Interaction with other medicinal products and other forms of interaction.

Do not use together with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use.

The product should not be swallowed, and contact with the eyes should be avoided, as the product contains ethanol.

The product should be used with caution in patients with epilepsy. It may lower the epileptic threshold and may provoke seizures in children.

Use with caution in patients with a predisposition to allergic reactions, including bronchial asthma, especially in patients with a history of allergy to acetylsalicylic acid.

If signs of hypersensitivity to the product occur, its use should be discontinued immediately.

Since the product contains ethanol, it should be administered with caution to patients with liver disease.

Prolonged use of the product is not recommended, as it may alter the natural microbial balance of the oral cavity and pharynx, increasing the risk of bacterial and fungal overgrowth.

If general clinical signs of bacterial infection appear, systemic antibacterial therapy should be initiated.

If symptoms persist for more than 5 days and/or body temperature remains elevated, the treatment strategy should be reassessed.

If inflammation worsens, treatment with the product should be discontinued.

Use during pregnancy or breastfeeding.

There are no human data available on the ability of hexetidine to cross the placenta or to be excreted in breast milk. Therefore, the product should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The product contains ethanol. Drivers are advised not to operate a vehicle or machinery within 30 minutes after using the product.

Method of Administration and Dosage

Use as a topical spray for the oral cavity and oropharynx.

Adults and children aged 15 years and older: 1 spray 4–6 times daily.

Children aged 6 to 15 years: 1 spray 2–3 times daily.

Duration of treatment: No longer than 5 days.

Children

Do not use in children under 6 years of age.

Overdose

No cases of overdose have been reported.

Alcohol intoxication due to the ethyl alcohol content may occur if a sufficient amount of the solution is absorbed in the oral cavity.

The concentration of hexetidine in the product is not toxic when used as directed.

Acute alcohol intoxication is unlikely. However, if a child swallows a large amount of the product, alcohol intoxication may occur due to its ethanol content.

No cases of hexetidine overdose leading to hypersensitivity reactions have been observed.

Treatment of overdose is symptomatic but rarely required. If a child ingests the contents of the bottle, seek immediate medical advice. Gastric lavage within 2 hours after ingestion should be considered, along with measures to counteract signs of alcohol intoxication.

Side effects.

Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.

Nervous system disorders: ageusia, dysgeusia, altered taste sensations within 48 hours (sweet taste sensation may change twice to bitter taste).

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion of the medication may lead to gastrointestinal disturbances, 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; mucosal sensitivity, namely burning sensation, numbness; irritation (pain, sensation of heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; development of mucosal ulcers, throat irritation, swelling at the site of contact, dryness of nasal/throat mucosa.

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 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 throat applicator in a cardboard carton.

Supply category. Over-the-counter.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of its business activities.

1, Gordiyenkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.