Oralor

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

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, glycerol, purified water.

Pharmaceutical form. Oral solution.

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

Pharmacotherapeutic group. Antiseptics. ATC code R02A A20.

Pharmacological Properties

Pharmacodynamics

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

Antibacterial and antifungal activity

Hexetidine exerts antibacterial activity 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 is similar to that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity

Choline salicylate produces analgesic, antipyretic, and anti-inflammatory effects. It is used for 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 classically used as a local anesthetic.

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

Clinical Characteristics

Indications. For local treatment of oral cavity 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.

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 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, especially in patients allergic to acetylsalicylic acid. If signs of hypersensitivity occur, the use of the drug must be discontinued immediately.

Due to the ethanol content, 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, 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 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 studies available 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 breastfeeding.

Ability to influence reaction rate 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 drug.

Method of Administration and Dosage

Apply locally for rinsing the oral cavity.

For one rinse of the oral cavity in adults and children aged 6 years and older: dissolve 10 mL, or 2 teaspoons, of the medicinal product in ¼ cup of warm water.

From 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 through the oral mucosa, alcohol intoxication may occur due to the presence of ethyl alcohol.

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.

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

Treatment of overdose is symptomatic and 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, 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 sensation 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 tickling sensation, swelling at the site of contact, dryness of nasal/throat mucosa.

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug 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 cardboard box with a measuring cup.

Supply category. Over-the-counter.

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

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