Hexaspray^® (Aerosol) Instructions for Use

Marketing Authorization Holder

Laboratoires Bouchara-Recordati (France)

ATC Code

R02AA20 (Other antiseptics)

Active Substance

Biclotymol (Rec.INN registered by WHO)

Dosage Form

Hexaspray®

Topical aerosol 2.5%: 30 g bottle

Dosage Form, Packaging, and Composition

Topical aerosol in the form of a homogeneous suspension, white with a yellowish tint, with a characteristic anise odor.

Excipients: benzyl alcohol – 0.5 g, disodium edetate – 0.0025 g, methylparahydroxybenzoate – 0.025 g, star anise fruit oil – 0.03 g, ammonium glycyrrhizinate – 0.02 g, sodium saccharin – 0.05 g, dispersed cellulose – 0.3 g, soy lecithin – 0.9 g, glycerol – 1 g, ethanol 96% – 1.06 g, purified water – up to 30 g.

30 g – glass bottles with polymer coating (1) with an applicator-spray – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptics

Pharmacological Action

An antiseptic for topical use in dentistry and ENT practice.

It has an antimicrobial effect.

It is active against staphylococci, streptococci, and corynebacteria.

It has a local anesthetic and anti-inflammatory effect.

Indications

• Infectious and inflammatory diseases of the oral cavity, pharynx, and larynx caused by susceptible pathogens.
• Use as part of combination therapy with other agents, such as enoxolone and lysozyme, for comprehensive management of oropharyngeal infections.

ICD codes

Dosage Regimen

Administer via inhalation for oropharyngeal application. For adults, use two sprays directed at the affected area three times per day.

For children over 6 years of age, use the same regimen of two sprays three times daily. Do not exceed the recommended frequency of application.

When used as a component of a multi-drug regimen, adhere strictly to the specific dosage instructions provided for that combination therapy.

Adverse Reactions

Monitor for signs of localized or systemic hypersensitivity following application. Allergic reactions are possible and may manifest as skin rash, pruritus, or mucosal irritation.

Discontinue use immediately if any signs of intolerance or allergic response appear and seek medical advice for persistent or severe reactions.

Drug Interactions

No specific drug interactions have been reported with topical oropharyngeal use. The systemic absorption of biclotymol is considered minimal.

Exercise caution when using concurrently with other topical medications applied to the same area, as the potential for local interaction exists.

Contraindications

• Hypersensitivity to biclotymol or any of the excipients listed in the composition, including benzyl alcohol, methylparahydroxybenzoate, or star anise fruit oil.
• Use in children under the age of 6 years due to insufficient safety and efficacy data in this pediatric population and potential for improper administration.

Overdose

Overdose from topical oropharyngeal use is unlikely due to the localized application and low systemic absorption. Accidental ingestion of large quantities may cause gastrointestinal irritation.

In case of accidental ingestion, seek medical attention if symptoms occur. Treatment should be symptomatic and supportive, as no specific antidote exists.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

If the symptoms of the disease do not disappear within 5 days of treatment, it is necessary to reconsider the therapy.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.