LORGEX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORHEX (LORHEX)

Composition:

Active substances: 100 ml of spray contains:
hexetidine, calculated as 100 % substance – 0.1 g;
choline salicylate, calculated as 100 % substance – 0.5 g;
chlorobutanol hemihydrate, calculated as 100 % anhydrous substance – 0.25 g;

Excipients: sodium saccharin, polysorbate 20, sorbic acid, ethanol 96 %, eucalyptol, methyl salicylate, lime oil, sage oil, glycerin, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, slightly colored solution 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.

Against aerobic strains, hexetidine generally exerts a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exerts 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 provides analgesic, antipyretic, and anti-inflammatory effects. It is used for the treatment of diseases of the oral cavity.

Analgesic activity. Chlorobutanol provides 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.

Clinical characteristics.

Indications.

An 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 increased airway sensitivity.

Interaction with other medicinal products and other forms of interaction.

Do not use concomitantly with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use.

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

Use with caution in patients with epilepsy. The product may lower the epileptic threshold and provoke seizures in children.

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

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

Since the medicinal product contains ethanol, it should be prescribed with caution to patients with liver diseases.

Prolonged use is not recommended, as it may alter the natural microbial balance of the oral cavity and throat, with a 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 the product should be discontinued.

Use during pregnancy or breastfeeding.

There are no human data on the ability of hexetidine to cross the placenta or its excretion in breast milk; therefore, the medicinal product should not be used during pregnancy or lactation.

Ability to influence reaction rate 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 product.

Method of Administration and Dosage

Use as a topical agent for oral and oropharyngeal irrigation.

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

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

Treatment duration — no longer than 5 days.

Children

Do not use in children under 6 years of age.

Overdose

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

Alcohol intoxication due to the presence of ethanol may occur if a sufficient amount of the solution is absorbed through the oral mucosa.

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

Acute alcohol intoxication is unlikely. However, if a child ingests a large dose of the medicinal product, 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 ingests the contents of the bottle, seek immediate medical advice. Consider the possibility of gastric lavage within 2 hours after ingestion, and take measures to counteract symptoms of alcohol intoxication.

Adverse reactions.

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

Nervous system disorders: ageusia, dysgeusia, altered taste sensations within 48 hours (sweet taste 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 (burning, numbness); irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; ulceration of the mucosa; throat irritation; swelling at the site of contact; dryness of nasal/throat mucosa.

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua/.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 50 ml in a glass bottle, 1 bottle with a spray pump in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer. JSC FF "Viola".

Manufacturer's address and location of business activity.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063. Tel.: 0800-33-12-72. www.violapharm.com