Septolete^® (Pastilles) Instructions for Use

ATC Code

R02AA20 (Other antiseptics)

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

A combined medicinal product for topical use.

Benzalkonium chloride and Thymol have antiseptic properties, are active against gram-positive bacteria, and have a fungicidal effect on Candida albicans and some lipophilic viruses.

Menthol and Peppermint oil have a moderate analgesic and deodorizing effect.

Eucalyptus oil reduces mucus secretion in the upper respiratory tract and facilitates breathing.

Indications

Use for the local treatment of infectious and inflammatory conditions affecting the oral cavity, pharynx, and larynx.

• Infectious and inflammatory diseases of the oral cavity, pharynx, larynx: pharyngitis, laryngitis, tonsillitis.
• Inflammation of the gums and oral mucosa (gingivitis, stomatitis).

ICD codes

Dosage Regimen

Administer by allowing the pastille to dissolve slowly in the mouth. Do not chew or swallow whole. A single dose is one pastille.

Take one pastille every 2-3 hours. Do not exceed the maximum daily dose. For adults and children over 12 years: up to 8 pastilles per day. For children over 10 years: up to 6 pastilles per day. For children over 4 years: up to 4 pastilles per day.

Adverse Reactions

Adverse reactions are generally infrequent and mild. From the digestive system: nausea, diarrhea.

Allergic reactions are possible in patients with known hypersensitivity to any component of the drug. Discontinue use immediately if signs of hypersensitivity, such as skin rash or itching, occur.

Contraindications

Do not use under any circumstances if any of the following conditions are present.

• Known hypersensitivity to benzalkonium chloride, thymol, menthol, peppermint oil, eucalyptus oil, or any other component of the drug.
• Children under 4 years of age due to the risk of choking and underdeveloped ability to use lozenges safely.

Drug Interactions

Avoid concurrent use with other antiseptic agents intended for dissolution in the oral cavity, as this may lead to mutual inactivation, particularly with benzalkonium chloride.

Do not take with milk, as it significantly reduces the antiseptic activity of benzalkonium chloride, compromising the therapeutic effect.

Overdose

Symptoms of overdose are related to the local effects of the components and may include gastrointestinal disturbances such as nausea, vomiting, and diarrhea.

In case of accidental ingestion of a large number of pastilles, seek immediate medical attention or contact a Poison Control Center. Treatment is symptomatic and supportive.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is possible only on the recommendation of a doctor.

Pediatric Use

Contraindication: children under 4 years of age.

Special Precautions

It is not recommended to use simultaneously with milk, because milk reduces the antiseptic activity of benzalkonium chloride.

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.