Angilor

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

Composition:

Active substances: 100 ml of spray contains 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 aromatic odor.

Pharmacotherapeutic group. Agents used in throat diseases. 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, with weak bactericidal activity. Against anaerobic strains, hexetidine has 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 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 irrigations). Classically, it can 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 mucous membrane of the oral cavity and oropharynx.

Contraindications.

• Hypersensitivity to any component of the medicinal product;
• atrophic pharyngitis;
• bronchial asthma or any other respiratory tract diseases associated with existing airway hyperreactivity.

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

The product should be used 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 product contains ethanol, it should be prescribed 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 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 remains elevated, the treatment strategy should be reassessed.

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

Use during pregnancy or breastfeeding.

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

Ability to influence reaction speed when driving or operating machinery.

The 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 as a topical oral and oropharyngeal spray.

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 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 product is not toxic when used as directed.

Acute alcohol intoxication is unlikely. However, if a child ingests a large dose of the 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 has ingested the contents of the bottle, seek immediate medical attention. Gastric lavage should be considered within 2 hours after ingestion, along with measures to counteract symptoms of alcohol intoxication.

Side effects.

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 turn bitter twice).

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; development of mucosal ulcers, throat irritation, swelling at the site of contact, dryness of nasal/throat mucosa.

Shelf life: 2 years.

Storage conditions.

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

Keep out of reach of children.

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

Supply category. Over-the-counter.

Manufacturer.

JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Street, Academician, Zaporizhzhia, Ukraine, 69063.