Septolète® total

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Septolete® total (Septolete® total)

Composition:

Active substances: benzidamine hydrochloride, cetylpyridinium chloride;

1 ml of solution contains 1.5 mg of benzidamine hydrochloride and 5 mg of cetylpyridinium chloride;

Excipients: ethanol (96%), glycerol, macrogolglycerol hydroxystearate, sodium saccharin, peppermint oil, purified water.

Pharmaceutical form. Oral spray, solution.

Main physicochemical properties: clear solution ranging from colorless to slightly yellow.

Pharmacotherapeutic group.

Throat preparations. Antiseptics. Other throat preparations. ATC code R02AX03.

Pharmacological properties.

Pharmacodynamics.

Mechanism of action

Benzidamine hydrochloride is a non-steroidal anti-inflammatory and analgesic agent. Its mechanism of action is believed to be related to inhibition of prostaglandin synthesis, thereby reducing signs of inflammation (such as pain, redness, swelling, and heat). Benzidamine hydrochloride also exerts a moderate local anesthetic effect.

Cetylpyridinium chloride is an antiseptic agent belonging to the quaternary ammonium compounds group. It acts as a cationic detergent. Quaternary ammonium compounds bind to the surface of bacterial cells, penetrate through it, and bind to the cytoplasmic membrane of microorganisms. As a result of binding, the cytoplasmic membrane of microbes increases permeability for low-molecular-weight components, primarily potassium ions. Subsequently, quaternary ammonium compounds penetrate into the cell, disrupting cellular functions and thus destroying it.

Cetylpyridinium chloride has a broad spectrum of antimicrobial activity. Its bactericidal activity is most pronounced against gram-positive bacteria (particularly Staphylococcus), as well as antifungal activity (e.g., against Candida and Saccharomyces) and antiviral activity against certain enveloped viruses. Gram-negative bacteria are moderately sensitive to cetylpyridinium chloride, whereas some strains of Pseudomonas are relatively insensitive.

Pharmacokinetics.

Absorption

Of the two active substances, only benzidamine is absorbed; therefore, no systemic pharmacokinetic interactions occur.

Evidence of benzidamine absorption through the oral and pharyngeal mucosa comes from detectable plasma concentrations, which are insufficient to produce a systemic effect.

Distribution

The volume of distribution of the drug is the same for both the lozenge and the spray formulations.

Elimination

Elimination occurs primarily via urine, mostly in the form of inactive metabolites. The elimination half-life and systemic clearance of the drug are similar across all pharmaceutical forms.

Clinical characteristics.

Indications.

Symptomatic treatment of infections of the throat and oral cavity (pharyngitis, laryngitis, gingivitis, conditions before and after tooth extraction).

Contraindications.

Hypersensitivity to the active substances or to any of the excipients.

Children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

SeptoleteÒ Total should not be used simultaneously with other antiseptics.

Instructions for use

Do not use Septolète® Total for more than 7 days. If there is no improvement within 3 days, consult a doctor.

Do not use Septolète® Total in combination with anionic compounds present in toothpastes (as they reduce the effectiveness of cetylpyridinium chloride); therefore, it is not recommended to use the product immediately before or after tooth brushing.

Do not use if there are wounds in the mouth due to delayed healing caused by cetylpyridinium chloride.

In cases of severe infections accompanied by high fever, headache, or vomiting, patients should consult a doctor, especially if there is no improvement within three days.

If a patient suffers from chronic cough or hoarseness, medical advice should be sought.

Prolonged local use of medicinal products may lead to sensitization; in such cases, treatment should be discontinued, medical advice sought, and appropriate therapy initiated.

Avoid direct contact of Septolète® Total spray with the eyes; do not inhale the spray.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Septolète® Total is sugar-free and therefore may be used by patients with diabetes.

Use during pregnancy or breastfeeding

Pregnancy

Due to insufficient data on the use of Septolète® Total during pregnancy, its use is not recommended.

Breastfeeding period

It is unknown whether the medicinal product passes into breast milk, but a risk to newborns and infants cannot be excluded. The decision whether to discontinue breastfeeding or to refrain from using Septolète® Total should be made by taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Ability to influence reaction rate when driving or operating machinery

Septolète® Total has no effect or has a negligible effect on reaction speed when driving or operating machinery.

Method of administration and dosages.

Adults and children aged 12 years and older: one dose equals 1–2 sprays. Repeat every 2 hours, 3–5 times per day.

Elderly patients should use the adult dose.

Children aged 6 to 12 years: one dose equals 1 spray. Repeat every 2 hours, 3–5 times per day.

To achieve optimal effect, do not use the product immediately before or after tooth brushing.

Do not exceed the recommended doses.

Septolète® Total can be used for up to 7 days.

Method of administration

Before first use of Septolète® Total, or if the spray has not been used for a prolonged period (at least 1 week), press the dosing pump several times to ensure a uniform spray.

Before use, remove the plastic cap.

After each use, the spray should be closed with the plastic cap.

With each single spray actuation, 0.1 mL of solution is released in the form of a spray, containing 0.15 mg of benzidamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

Children.

Use in children under 6 years of age is contraindicated due to the pharmaceutical form.

For children aged 6–11 years, this medicinal product should be used under adult supervision.

Overdose.

Due to the low concentrations of both active substances in Septolete® Total, overdose is unlikely when used at recommended doses.

Symptoms

Toxic effects of benzidamine overdose include excitement, convulsions, sweating, ataxia, tremor, and vomiting.

Signs and symptoms of intoxication following ingestion of large doses of cetylpyridinium chloride include nausea, vomiting, dyspnea, cyanosis, asphyxia due to paralysis of respiratory muscles, CNS depression, arterial hypotension, and coma. The lethal dose in humans is approximately 1–3 grams (which exceeds the maximum daily dose of Septolete® Total spray by 200–600 times).

Treatment

As there is no specific antidote, treatment of acute overdose is symptomatic.

Side effects

Very common ≥ 1/10;

common ≥ 1/100 to < 1/10;

uncommon ≥ 1/1000 to < 1/100;

rare ≥ 1/10000 to < 1/1000;

very rare < 1/10000;

unknown (cannot be estimated from the available data)

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national reporting system.

Shelf life.

3 years.

After opening the bottle, the product should be used within 12 months.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

30 ml solution in a high-density polyethylene plastic bottle with a white metered spray pump and a blue polypropylene cap, packaged in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

KRKA, d.d., Novo mesto, Slovenia / KRKA, d.d., Novo mesto, Slovenia.

Manufacturer's address and place of business.

Šmarješka cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.