Orvilor

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

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

100 ml of solution 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 solution.

Main physicochemical characteristics: clear, slightly colored solution with a characteristic pleasant odor.

Pharmacotherapeutic group. Antiseptics. ATC code R02A A20.

Pharmacological Properties

Pharmacodynamics

The drug's action 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.

Hexetidine generally produces a bacteriostatic effect on aerobic strains, 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 oral cavity diseases.

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 classically used as a local anesthetic.

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

Clinical characteristics

Indications. For local treatment of oral infections; for 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 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 for use.

When using the medicinal product, do not swallow it 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, the drug should be discontinued immediately.

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

If inflammation worsens, treatment with the 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 breastfeeding.

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 30 minutes after using the product.

Method of Administration and Dosage

Apply topically for rinsing the oral cavity.

For one mouth rinse in adults and children aged 6 years and older: dissolve 10 ml (2 teaspoons) of the medicinal product 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 reports of overdose with this medicinal product have been reported.

If a sufficient amount of the solution is absorbed in the oral cavity, alcohol intoxication may occur due to the presence of ethanol.

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 ethanol.

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

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

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 to bitter taste).

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 heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; ulceration of the mucosa; throat tickling sensation; swelling at the site of contact; dryness of nasal/oral mucosa.

Reporting of adverse reactions after drug registration is highly important. It enables ongoing 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 reach and sight of children.

Packaging. 120 ml or 200 ml in a glass or polymer bottle in a carton box with a measuring cup.

Prescription status. Over-the-counter (without prescription).

Manufacturer. Private Joint-Stock Company "Pharmaceutical Factory "Viola".

Manufacturer's address and location of business activity. 75 Amosova Street, Zaporizhzhia, 69063, Zaporizhzhia Oblast, Ukraine.