Angilex-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANGILEX-ZDOROVYE (ANGILEX-ZDOROVYE)

Composition:

Active substances: hexetidine; choline salicylate; chlorobutanol hemihydrate recalculated to chlorobutanol.

1 ml of solution contains hexetidine 1 mg, choline salicylate 5 mg, chlorobutanol hemihydrate recalculated to chlorobutanol 2.5 mg;

Excipients: sodium saccharin, polysorbate, propionic acid, ethanol 96%, lemon oil, anise oil, menthol, peppermint oil, eucalyptol, methyl salicylate, purified water.

Pharmaceutical form. Oral solution.

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 drug is due to its three active ingredients.

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.

It should be noted that against aerobic strains, it primarily has a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exhibits pronounced bactericidal activity. 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. Used in the treatment of oral cavity diseases.

Analgesic activity is provided by chlorobutanol. Used in otorhinolaryngology (nasal drops, rinsing) and in dental practice (applications and irrigation) as a local anesthetic.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Local treatment of infectious diseases and inflammatory processes of the oral cavity and pharynx: tonsillitis, acute and chronic tonsillitis, pharyngitis, laryngitis; gingivitis, stomatitis, aphthae.

Oral cavity care after dental procedures.

Contraindications.

Known allergy (hypersensitivity) to the components of the drug. Contraindicated in patients with atrophic pharyngitis, bronchial asthma, or any other respiratory tract diseases associated with existing respiratory tract hypersensitivity.

Interaction with other medicinal products and other forms of interaction.

Do not use together with products containing antiseptics (interaction may occur with other antiseptic medicinal products). 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. 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 occur, systemic antibacterial therapy should be considered. If symptoms persist for more than 5 days and/or body temperature is elevated, the treatment approach should be reassessed.

The preparation should be used with caution in patients with epilepsy, as it may lower the epileptic threshold and provoke seizures in children. Use with caution in patients with allergic reactions, including asthma, particularly in those with hypersensitivity to acetylsalicylic acid. If signs of hypersensitivity to the drug occur, treatment should be discontinued immediately. As the preparation contains ethanol, it should be administered with caution to patients with liver disease. There is a risk of laryngospasm in children due to the presence of menthol in the preparation.

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

Use during pregnancy or breastfeeding.

There are no human data available on the ability of hexetidine to cross the placenta or its excretion in breast milk. Therefore, the preparation should not be used during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

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

Method of Administration and Dosage

Apply locally for rinsing the oral cavity.

For one mouth rinse, adults and children aged 6 years and older: dissolve 2 teaspoons of the preparation in ¼ cup of warm water. Perform from 2 to 4 rinses per day. Do not swallow.

Treatment duration – no longer than 5 days.

Children. The preparation should not be used in children under 6 years of age.

Overdose.

There have been no reports of overdose. Alcohol intoxication due to the ethyl alcohol content may occur if a sufficient amount of the preparation is ingested.

The concentration of hexetidine contained in the preparation is not toxic when used as directed. Acute alcohol intoxication is extremely unlikely. However, if a child swallows a large dose of the preparation, alcohol intoxication may occur due to the ethyl alcohol content. There have been no cases of excessive hexetidine use leading to hypersensitivity reactions.

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

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, allergic reactions, including laryngospasm, bronchospasm, skin reactions.

Nervous system disorders: taste disturbances (including ageusia, dysgeusia) and smell disturbances, taste sensation changes within 48 hours (the sensation of "sweet" may twice change to the sensation of "bitter").

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. In case of accidental ingestion of the medication, gastrointestinal disturbances may occur, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin rashes.

General disorders and administration site conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity, namely burning, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; reduced sensitivity; mucosal paraesthesia; inflammation; blisters; ulceration of the mucosa; throat irritation, swelling at the site of contact, dryness of nasal/throat mucosa.

Shelf life. 3 years.

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

Do not freeze.

Packaging. 120 ml in a bottle in a box.

Category of release. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, building 22.