Hexosept®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEXOSEPT®

Composition:

Active substance: hexetidine;

1 g of the preparation contains hexetidine (calculated as 100 % substance) 2 mg;

Excipients: sodium saccharinate; citric acid, monohydrate; sodium hydroxide; glycerin; ethanol (96 %); macrogol lauryl ether; cineole (eucalyptol); levomenthol; peppermint oil; purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: the medicinal product is dispensed as an aerosol jet and forms a clear, almost colorless liquid with a characteristic menthol odor.

Pharmacotherapeutic group. Agents used in dentistry. Antimicrobial and antiseptic medicinal agents for local use in dentistry. Hexetidine. ATC code A01A B12.

Pharmacological properties.

Pharmacodynamics.

Hexetidine is an active substance with rapid and prolonged effect, belonging to the group of local antiseptics used in gingivodental and oropharyngeal applications.

It exhibits antibacterial and antifungal activity against a broad spectrum of pathogenic microorganisms responsible for oropharyngeal infections. Upon application, it demonstrates wound-healing, hemostatic, and local analgesic properties in the oral cavity and pharynx.

Hexetidine is a broad-spectrum antimicrobial agent. It is effective both in vivo and in vitro against Gram-positive and Gram-negative bacteria, as well as yeasts (Candida albicans) and fungi.

Specific pharmacokinetic studies on the use of HEXOSEPT® spray in humans have not been conducted.

After administration, dental plaque and residual concentrations of hexetidine on mucous membranes may be observed. Studies using radiolabeled hexetidine have shown that hexetidine can be detected in oral tissues from 8 to 10 hours after a single application, and in some cases, it may still be detected in oral tissues up to 65 hours after treatment.

Pharmacokinetics.

There are no clinical data available on the pharmacokinetics of hexetidine in humans.

The drug acts locally on the oral mucosa, and therefore, only minimal systemic absorption is expected.

The high affinity of hexetidine for proteins and polymers with electronegative sites explains its binding to bacteria and directly contributes to its prolonged local action on the oral mucosa due to residual concentrations of hexetidine. This affinity also explains binding to dental plaque, thus providing an anti-plaque effect. The antibacterial effect may persist for 10–14 hours after administration.

Studies on absorption following topical application of HEXOSEPT® spray or hexetidine in humans have not been performed.

No specific studies with HEXOSEPT® spray or hexetidine have been conducted in patients with impaired liver and/or kidney function or in elderly patients.

Clinical characteristics.

Indications.

Tonsillitis, pharyngitis, laryngitis, glossitis, as an adjunctive medicinal agent in throat inflammation, pre- and postoperative treatment in tonsillectomy, injuries of the oral cavity and pharynx, gingivitis, gum bleeding, stomatitis, oral ulcers, inflammation of dental sockets, halitosis, oral hygiene in severe diseases.

Contraindications.

HEXOSEPT® spray is contraindicated:

• in patients with hypersensitivity to hexetidine or to any other component of the medicinal product;
• in patients with bronchial asthma or any other respiratory tract diseases associated with existing airway hyperreactivity. Inhalation may cause bronchoconstriction;
• in atrophic pharyngitis.

Interaction with other medicinal products and other forms of interaction.

Interaction with other antiseptic medicinal products is possible. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

The medicinal product should be used with caution in patients with epilepsy. The medicinal product may reduce the epileptic threshold and cause seizures in children.

The medicinal product should be used with caution in patients with allergic reactions, including bronchial asthma, particularly in patients allergic to acetylsalicylic acid.

The medicinal product contains ethanol; therefore, it should be prescribed with caution to patients with liver diseases.

Inhalation of the medicinal product should be avoided during administration, as the spray may enter the respiratory tract and cause laryngospasm.

There is a risk of laryngospasm in children due to the presence of levomenthol in the formulation of the medicinal product.

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

Prolonged use is not recommended (without medical advice, do not use for more than 10 days).

Use during pregnancy or breastfeeding.

Adequate and well-controlled clinical studies on the use of hexetidine in pregnant or breastfeeding women have not been conducted. It is unknown whether hexetidine or its metabolites are excreted in breast milk. A negligible amount of hexetidine is systemically absorbed. It is unlikely that the use of hexetidine during pregnancy or breastfeeding poses a risk to the fetus or infant.

However, hexetidine should not be used during pregnancy or breastfeeding except when the potential benefit of treatment to the mother outweighs the possible risks to fetal or child development.

Ability to influence reaction speed while driving or operating machinery.

The medicinal product contains ethanol. Drivers are advised not to operate a vehicle or machinery for 30 minutes after administration of the medicinal product.

Method of Administration and Dosage

Adults and children aged 6 years and older

HEXOSEPT® spray is a topical preparation intended for use in the oral cavity.

Before use, remove the protective cap and attach the spray nozzle onto the valve stem. Before the first use, prime the pump by pressing down 4–6 times until a fine mist appears. Before each subsequent use, press the nozzle twice to ensure the solution reaches the spray mechanism and is properly dispensed. The medication is then ready for application. During administration, direct the spray nozzle toward the affected area of the oral cavity or throat and press the spray head vertically downward with the index finger. While using the medication, hold your breath and keep the canister in an upright vertical position with the spray nozzle on top; do not use the canister in an inverted position.

After use, remove the spray nozzle from the valve stem and rinse it thoroughly with warm water; replace the protective cap on the canister.

Use no more than 3 times daily (depending on the severity of symptoms or as directed by a physician).

The duration of treatment should be determined individually by a physician, based on the severity and clinical course of the condition.

Do not use for the treatment of prolonged or chronic symptoms.

Do not inhale, as this may provoke laryngospasm.

Consult a physician before starting treatment with this medication.

Children.

Do not use HEXOSEPT® spray in children under 6 years of age.

Overdose.

Ingestion of a large amount of the spray may cause nausea; however, significant systemic absorption is unlikely.

Alcohol intoxication may occur due to absorption of a sufficient amount of HEXOSEPT® spray, caused by its ethanol content.

The concentration of hexetidine contained in HEXOSEPT® spray is not toxic when the medication is used as directed.

There have been no reported cases of hexetidine overdose leading to hypersensitivity reactions.

Keep out of reach of children. In case of overdose, seek immediate medical attention.

Side effects.

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

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

Respiratory, thoracic and mediastinal disorders: cough, dyspnea, laryngospasm.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion of the product may cause gastrointestinal disturbances, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, angioedema.

General disorders and administration site conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity, such as burning sensation, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; development of mucosal ulcers.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as 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.

The medicinal product should not be used after the expiry date stated on the packaging.

Storage conditions.

Keep out of reach of children. Store at a temperature not exceeding 25 °C.

Packaging.

25 g in a bottle with a pump-type valve, spray nozzle, and protective cap; 1 bottle per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "STOMA".

Manufacturer's address and place of business.

3, Newtona Street, Kharkiv, Ukraine, 61105.