Angilex-zdorovya

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

Composition:
Hexetidine, choline salicylate, chlorobutanol hemihydrate.
Active substances: 1 ml of the preparation contains:

• hexetidine 1 mg,
• choline salicylate 5 mg,
• chlorobutanol hemihydrate (calculated as chlorobutanol) 2.5 mg.

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

Pharmaceutical form:
Oromucosal spray.

Basic physicochemical properties:
Clear, slightly colored solution with a specific pleasant odor.

Pharmacotherapeutic group:
Preparations used in throat diseases. Antiseptics.
ATC code: R02A A20.

Pharmacological properties

Pharmacodynamics:
The action of the preparation is due to three active ingredients.

Antibacterial and antifungal activity:
Hexetidine has antibacterial activity against both Gram-positive and Gram-negative microbial strains, both aerobic and anaerobic. It should be noted that against aerobic strains it has mainly a bacteriostatic effect, while its bactericidal action is weak. Against anaerobic strains, hexetidine has a pronounced bactericidal effect. The mechanism of action is based on 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 exerts analgesic, antipyretic, and anti-inflammatory effects.

Analgesic activity:
Provided by chlorobutanol. Used in otolaryngology (nasal drops, rinsing) and in dental practice (applications and spraying) as an anesthetic.

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

Clinical characteristics

Indications:
Antibacterial and analgesic agent for local treatment of diseases of the oral mucosa and oropharynx.

Contraindications:
Hypersensitivity to the components of the preparation. 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. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use:
Do not swallow the preparation and avoid contact with eyes, as it contains ethanol. 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 is elevated, the treatment strategy should be reassessed.

The preparation should be used with caution in patients with epilepsy. The preparation 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 to the preparation occur, its use should be discontinued immediately.

The preparation contains ethanol; therefore, it should be prescribed with caution to patients with liver disease. There is a risk of laryngospasm in children due to the presence of menthol. If inflammation worsens, treatment with the preparation should be discontinued.

Use during pregnancy or breastfeeding:
There are no human study data on the possible placental penetration or excretion into breast milk of hexetidine; therefore, the preparation should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery:
The preparation contains ethanol. Drivers are not recommended to operate a vehicle within 30 minutes after application of the preparation.

Method of administration and dosage:
Apply as a local agent for spraying the oral cavity and oropharynx.

• 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: not longer than 5 days.

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

Overdose:
No reports of overdose have been received.
Alcohol intoxication may occur due to absorption of a sufficient amount of solution in the oral cavity, due to the content of ethyl alcohol. The concentration of hexetidine in the preparation is not toxic when used as directed. Acute alcohol intoxication is unlikely. If a child swallows a large dose of the preparation, alcohol intoxication may occur due to the content 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. In case a child swallows the contents of the bottle, seek immediate medical attention. 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, angioneurotic edema, allergic reactions, including laryngospasm, bronchospasm.
Nervous system disorders: taste disturbances (including ageusia, dysgeusia), altered taste sensations for up to 48 hours (the sensation of "sweet" may change twice to the sensation of "bitter").
Respiratory, thoracic and mediastinal disorders: cough, dyspnea.
Gastrointestinal disorders: dry mouth, dysphagia, enlargement of salivary glands, pain on swallowing. If the preparation is accidentally swallowed, gastrointestinal disturbances may occur, primarily nausea and vomiting.
Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).
General disorders and site of administration conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity, i.e., 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 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. Keep out of reach of children.

Packaging:
30 ml in a bottle with a spray nozzle and protective cap in a box;
50 ml in a bottle with an oral spray device and protective cap in a box.

Category of release: Over-the-counter (without prescription).

Manufacturer:
LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYE".
Address of manufacturer and location of business activity:
22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.