Septolete^® Plus (Spray, Pastilles) Instructions for Use

ATC Code

R02A (Preparations for the treatment of throat diseases)

Active Substances

Cetylpyridinium chloride (Rec.INN registered by WHO)

Benzocaine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic + local anesthetic

Pharmacological Action

A combined medicinal product for topical use in ENT practice and dentistry.

It has a local anesthetic and antimicrobial action.

Cetylpyridinium chloride is an antiseptic that has antimicrobial, antifungal, and virucidal action.

Benzocaine is a local anesthetic agent that reduces pain when swallowing, which often accompanies infectious and inflammatory processes of the oral cavity and throat.

Pharmacokinetics

Quaternary ammonium compounds, to which Cetylpyridinium chloride belongs, are absorbed only by 10-20%. The unabsorbed part is excreted through the intestine unchanged.

Benzocaine is poorly soluble in water, which determines its minimal absorption. Absorbed Benzocaine is hydrolyzed mainly by plasma cholinesterase, a small part is metabolized in the liver. Metabolites are excreted by the kidneys.

Indications

Infectious and inflammatory diseases of the oral cavity, pharynx and larynx: pharyngitis, laryngitis, initial stage of tonsillitis; inflammation of the gums and oral mucosa (gingivitis, stomatitis).

ICD codes

Dosage Regimen

For topical use only. Administer every 2-4 hours as required. The specific single dose is determined by the patient’s age and the selected dosage form.

For the spray, apply 3-4 sprays directly to the affected area of the throat or oral cavity. Direct the spray nozzle accurately before administration.

For pastilles, dissolve one lozenge slowly in the mouth until completely dispersed. Do not chew or swallow the lozenge whole.

Adhere strictly to the maximum daily frequency of administration. Do not exceed 8 doses within a 24-hour period.

In children aged 6 to 12 years, use only under adult supervision to ensure proper administration and to prevent choking.

Maintain an interval of at least 30-60 minutes between administration and eating or drinking. Avoid food and milk immediately after use to prevent reduction of therapeutic effect.

Discontinue use and consult a physician if symptoms persist for more than 3 days or worsen. Seek immediate medical advice if signs of a severe infection appear.

Adverse Reactions

From the digestive system very rarely – nausea, diarrhea, upon occurrence of which the drug should be discontinued.

Other very rarely – allergic reactions.

Contraindications

Children under 6 years of age; hypersensitivity to the components of the medicinal product.

With caution

Open wounds of the oral cavity (because Cetylpyridinium chloride slows down wound healing).

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

Do not exceed the recommended doses.

In more severe infectious processes accompanied by fever, headache and vomiting, it is necessary to consult a doctor, especially if the condition does not improve within 3 days from the start of therapy.

Drug Interactions

Simultaneous use with food and milk may reduce the local antiseptic and anesthetic effects of the medicinal product.

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.