Angilor

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

Composition:

Active substances: 100 ml of solution contain 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, 96 % ethanol,
eucalyptol, methyl salicylate, lime oil, sage oil, glycerin, purified water.

Pharmaceutical form. Solution for the oral cavity.

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

Pharmacotherapeutic group. Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The action of the drug is due to 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 has a bacteriostatic effect; its bactericidal activity is weak. Against anaerobic strains, hexetidine has a pronounced bactericidal effect. The mechanism of action involves competitive inhibition with thiamine: the structure of hexetidine resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity.

Choline salicylate exerts analgesic, antipyretic, and anti-inflammatory effects. It can be used for the treatment of oral cavity diseases.

Analgesic activity.

Chlorobutanol exerts an analgesic effect. It can be used, in particular, in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and sprays). 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.

Local treatment of oral cavity infections. Postoperative dental care.

Contraindications.

• Hypersensitivity to any component of the drug;
• 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 it contains ethanol.

The medication should be used 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, particularly in patients with hypersensitivity to acetylsalicylic acid. If signs of hypersensitivity to the drug occur, its use should be discontinued immediately.

Since the preparation contains ethanol, it 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, 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 strategy should be re-evaluated.

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

Use during pregnancy or breastfeeding

There are no human study data on the ability of hexetidine to cross the placenta or be excreted in breast milk; therefore, the drug should not be used during pregnancy or while breastfeeding.

Ability to influence reaction speed when driving or operating machinery

The preparation contains ethanol. Drivers are advised not to operate a vehicle or machinery for 30 minutes after using the drug.

Method of Administration and Dosage

Use as a topical agent for rinsing the oral cavity.

For one rinse of the oral cavity in adults and children aged 6 years and older: dissolve 10 ml (2 teaspoons) of the preparation 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

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

Alcohol intoxication may occur due to absorption of a sufficient amount of the solution in the oral cavity, caused by the presence of ethyl alcohol.

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 ethyl alcohol.

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

Treatment of overdose is symptomatic but rarely required. In case 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 counteract signs of alcohol intoxication.

Adverse reactions.

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

Nervous system disorders: ageusia, dysgeusia, altered taste sensations for up to 48 hours (sweet taste may change twice to a 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; vesicles; development of ulcers on the mucosa; throat irritation, swelling at the site of contact, dryness of nasal/oral mucosa.

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 with a measuring cup.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

JSC "Pharmaceutical Factory "Viola".

Manufacturer's address and location of business activity.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.