Hepilor®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEPILOR® (HAPPYLOR)

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

1 ml of spray contains: hexetidine, recalculated to 100 % substance – 1 mg, choline salicylate 80 %, recalculated to 100 % substance – 5 mg, chlorobutanol hemihydrate, recalculated to 100 % anhydrous substance – 2.5 mg;

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

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: clear liquid, or with slight opalescence, with a characteristic aromatic odor and alcoholic-anise taste, contained in a bottle with a pump valve equipped with an atomizer. The preparation is dispensed from the bottle through the atomizer as an aerosol jet.

Pharmacotherapeutic group. Preparations used in throat diseases.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

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

Antibacterial and antifungal activity.

Hexetidine exerts antibacterial effects against both Gram-positive and Gram-negative microbial strains, including both aerobes and anaerobes.

Against aerobic strains, it generally has a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exhibits pronounced bactericidal activity. The mechanism of action involves competitive inhibition 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 can be used for the treatment of oral cavity diseases.

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 which they are gradually released.

Clinical characteristics.

Indications.

Antibacterial and analgesic agent for local treatment of diseases of the oral mucosa and oropharynx.

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 simultaneously with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

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

The preparation should be used with caution in patients with epilepsy. The preparation may lower the epileptic threshold and may cause seizures in children.

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

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

Since the preparation contains ethanol, it should be used with caution in 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 is elevated, the treatment strategy should be re-evaluated.

If inflammation worsens, treatment with this preparation should be discontinued.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Use during pregnancy or breastfeeding

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

Ability to affect reaction rate when driving or operating machinery

The preparation contains ethanol. It is not recommended for drivers to operate a vehicle or machinery within 30 minutes after using the preparation.

Method of Administration and Dosage

Apply locally by spraying into the oral cavity.

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.

Treatment duration – no longer than 5 days.

Children

The medicinal product should be used in children aged 6 years and older.

Overdose

There have been no reports of overdose with this medicinal product.

Due to absorption of a sufficient amount of the solution in the oral cavity, alcohol intoxication may occur because of the ethanol content.

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 dose of the product, alcohol intoxication may occur due to the presence of ethyl alcohol.

Cases of excessive hexetidine use leading to hypersensitivity reactions have not been reported.

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

Adverse reactions.

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

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

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. In case of accidental ingestion, gastrointestinal disturbances 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; mucosal sensitivity, including 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 in the original packaging at a temperature not exceeding 25°C. Do not freeze.

Keep out of reach of children.

Packaging.

20 ml or 50 ml in a bottle. 1 bottle in a carton.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. JSC "Farmak".

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

74, Kyrylivska Street, Kyiv, 04080, Ukraine.