Hepilor®

INSTRUCTIONS for medical use of the medicinal product HEPILOR® (HAPPYLOR)

Composition:

Active substances: hexetidine, choline salicylate 80%, chlorobutanol hemihydrate;

100 ml of solution contain: hexetidine calculated as 100% substance – 0.1 g, choline salicylate 80% calculated as 100% substance – 0.5 g, chlorobutanol hemihydrate calculated as 100% anhydrous substance – 0.25 g;

Excipients: ethanol 96%, sodium saccharin, polysorbate 20, propionic acid, lemon oil, anise oil, menthol (levomenthol), eucalyptol, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear or slightly opalescent liquid with a characteristic aromatic odor and a taste of alcoholic-anise flavor.

Pharmacotherapeutic group.

Antiseptics. ATC code R02A A20.

Pharmacological Properties.

Pharmacodynamics.

The action of the medicinal product is due to three active components.

Antibacterial and antifungal activity.

Hexetidine exhibits antibacterial activity against both Gram-positive and Gram-negative microbial strains, as well as against both aerobes and anaerobes.

Against aerobic strains, it generally exerts a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine has a pronounced bactericidal effect. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine is similar to that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity.

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

Analgesic activity.

Chlorobutanol has analgesic properties. 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.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Local treatment of oral infections. Postoperative care in dentistry.

Contraindications.

• Hypersensitivity to any component of the medicinal product;
• 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 medication should not be swallowed, and contact with the eyes should be avoided, as it contains ethanol.

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

Use with caution in patients with a predisposition to allergic reactions, including bronchial asthma, particularly in patients allergic to acetyl salicylic acid. If signs of hypersensitivity to the drug occur, its use should be discontinued immediately.

Since the drug contains ethanol, it should be prescribed with caution to patients with liver disease.

Prolonged use 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 re-evaluated.

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

Use during pregnancy or breastfeeding

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

Ability to affect reaction rate when driving or operating machinery

The product contains ethanol. Driving or operating machinery is not recommended for 30 minutes after administration of the drug.

Method of Administration and Dosage

Use as a topical agent for rinsing the oral cavity.

For one mouth rinse in adults and children aged 6 years and older: measure 10 ml of solution using the dosing cup or 2 teaspoons of the preparation and dissolve in ¼ cup of warm water.

Perform 2 to 4 rinses per day.

Do not swallow.

Treatment duration: 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 presence of ethyl alcohol may occur if a sufficient amount of the solution is absorbed in the oral cavity.

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

Acute alcohol intoxication is unlikely. However, if a child swallows a large dose of the preparation, alcohol intoxication may occur due to the presence of ethyl alcohol.

No cases of excessive hexetidine use leading to hypersensitivity reactions have been reported.

Treatment of overdose is symptomatic and rarely required. In case a child has swallowed the contents of the bottle, seek immediate medical attention. Gastric lavage should be considered within 2 hours after ingestion, along with measures to counteract signs of alcohol intoxication.

Adverse reactions.

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

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

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion of the drug 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 warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; vesicles; development of mucosal ulcers; throat irritation, swelling at the site of contact, dryness of nasal/throat mucosa.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach and sight of children.

Packaging. 100 ml in a bottle. 1 bottle with a measuring cup in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.