Extralor

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

Composition:

Active substances:

hexetidine, choline salicylate, chlorobutanol hemihydrate;

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, ethanol 96 %,

eucalyptol, methyl salicylate, lime oil, sage oil, glycerin, 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 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 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. 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). 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 infections. 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 existing airway 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.

When using the medication, do not swallow and avoid contact with eyes, as it contains ethanol.

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

Since the medication contains ethanol, it 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 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 regimen should be re-evaluated.

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

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

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

Administration and Dosage.

Use as a topical agent for mouth rinsing.

For one mouth rinse in adults and children aged 6 years and older: dissolve 10 ml or 2 teaspoons of the preparation in ¼ glass of warm water.

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 have been received.

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. If a child has swallowed the contents of the bottle, seek immediate medical attention. Gastric lavage within 2 hours after ingestion should be considered, along with measures to counteract symptoms of alcohol intoxication.

Adverse reactions.

Immune system side effects: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.

Nervous system side effects: ageusia, dysgeusia, altered taste sensations within 48 hours (sweet taste may change twice to bitter taste).

Respiratory system, thoracic organs and mediastinum side effects: cough, dyspnea.

Gastrointestinal system side effects: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Gastrointestinal disturbances, primarily nausea and vomiting, may occur if the product is accidentally swallowed.

Skin and subcutaneous tissue side effects: 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; local swelling at site of contact; dryness of nasal/oral mucosa.

Reporting adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of 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, with a measuring cup, in a carton.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

JSC FF "Viola".

Manufacturer's address and location of business activity.

75 Amosova Street, Zaporizhzhia, Ukraine, 69063.