ORALOR

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

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

100 ml of spray contain

hexetidine, recalculated to 100 % substance, 0.1 g,

choline salicylate, recalculated to 100 % substance, 0.5 g,

chlorobutanol hemihydrate, recalculated to 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 pleasant odor.

Pharmacotherapeutic group. Preparations used in throat diseases. Antiseptics. 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, as well as against both aerobes and anaerobes.

Against aerobic strains, hexetidine generally produces 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 resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity. Choline salicylate produces analgesic, antipyretic, and anti-inflammatory effects. It is used in the treatment of diseases of the oral cavity.

Analgesic activity. Chlorobutanol produces an analgesic effect. It can be used, in particular, in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and irrigations). It is traditionally used as a local anesthetic.

The active substances bind to the mucous membrane of the oral cavity, from where they are gradually released.

Clinical characteristics

Indications. Use as 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 together with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions.

When using the medicinal product, do not swallow and avoid contact with eyes, as it contains ethanol.

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

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

If signs of hypersensitivity occur, administration of the drug must be discontinued immediately.

Due to the presence of ethanol, the medicinal product should be administered 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 reassessed.

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

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

Ability to affect reaction speed when driving or operating machinery. The medicinal product contains ethanol. Drivers are advised not to operate a vehicle or machinery for at least 30 minutes after using the product.

Method of Administration and Dosage

Apply locally by spraying into 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.

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 content of ethanol may occur if a sufficient amount of the solution is absorbed in the oral cavity.

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 ethanol.

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

Treatment of overdose is symptomatic and rarely required.

In case a child swallows the contents of the bottle, seek immediate medical attention. Gastric lavage should be considered within 2 hours after ingestion, along with measures to manage symptoms 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).

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 (burning, numbness); irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; ulceration of the mucosa, throat irritation, local 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 and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: 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 the reach 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: Private Joint-Stock Company Pharmaceutical Factory "Viola".

Manufacturer's address and location of operations: 75 Amosova Street, Zaporizhzhia, Zaporizhzhia region, 69063, Ukraine.