Stopangin^® (Spray) Instructions for Use

Marketing Authorization Holder

IVAX Pharmaceuticals, s.r.o. (Czech Republic)

ATC Code

R02AA20 (Other antiseptics)

Active Substance

Hexetidine (Rec.INN registered by WHO)

Dosage Form

Stopangin®

Spray for topical use 0.2%: bottle 45 ml with mechanical sprayer

Dosage Form, Packaging, and Composition

Spray for topical use 0.2% in the form of a transparent, colorless or almost colorless liquid with a specific odor; after spraying, a finely dispersed aerosol is formed.

Excipients: methyl salicylate, anise essential oil, eucalyptus essential oil, orange flower essential oil, sassafras essential oil, peppermint essential oil, levomenthol, sodium saccharin monohydrate, glycerol 85%, ethanol 96%.

45 ml – bottles (1) with a mechanical sprayer – cardboard boxes.

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, and hemostatic action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent. It shows activity against gram-positive and gram-negative microorganisms and fungi.

Indications

• Inflammatory diseases of the oral cavity and larynx, including acute and chronic pharyngitis, tonsillitis, and laryngitis.
• Fungal diseases affecting the oral cavity and larynx.
• Antiseptic treatment of the oral cavity and larynx before and after surgical operations and in case of injuries.
• Use as an auxiliary agent for acute respiratory viral infections.
• For oral hygiene maintenance.

ICD codes

Dosage Regimen

Apply the spray topically to the affected areas of the oral cavity and pharynx.

For adults and children over 12 years of age, administer two sprays per application. Use three to five times daily, preferably after meals.

Direct the spray nozzle towards the affected area. Hold your breath during spraying. Refrain from eating or drinking for 30 minutes after application.

Adverse Reactions

Rarely, local hypersensitivity reactions such as allergic contact dermatitis may occur.

Temporary taste and smell disorders have been reported. In cases of severe irritation or allergic reaction, discontinue use immediately and consult a physician.

Drug Interactions

No specific drug interactions are known. The systemic absorption of hexetidine after topical application is negligible.

Concomitant use with other topical oral preparations is not recommended to avoid potential inactivation of the active substance.

Contraindications

• Hypersensitivity to hexetidine or to any of the excipients, including essential oils and ethanol.
• Contraindicated in patients with a known history of allergic reactions to similar antiseptic agents.
• Do not use in children under 12 years of age due to lack of data on safety and efficacy in this population.

Overdose

Accidental ingestion of large quantities may lead to symptoms of alcohol intoxication due to the ethanol content, including dizziness, nausea, and central nervous system depression.

In case of ingestion, seek immediate medical attention. Treatment is symptomatic and supportive. Gastric lavage is not recommended due to the risk of aspiration.

Special Precautions

Especially recommended for bedridden and care-dependent patients.

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.