Septolète® total lemon and honey

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Septolete® Total Lemon and Honey (Septolete® Total Lemon and Honey)

Composition:

Active substances: benzidamine hydrochloride, cetylpyridinium chloride;

Each lozenge contains 3 mg of benzidamine hydrochloride and 1 mg of cetylpyridinium chloride;

Excipients: peppermint oil, levomenthol, sucralose, citric acid, isomalt (type M) (E 953), lemon flavor, honey flavor, curcumin coloring agent (contains sodium benzoate (E 211)).

Pharmaceutical form. Lozenges.

Main physicochemical properties: round lozenges with beveled edges and uneven surface, light yellow to yellow in color, possibly with white spots, uneven coloring, air bubbles, and slightly serrated edges.

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 from 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 microorganism's cytoplasmic membrane. As a result of this 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, as well as antifungal activity (e.g., against Candida and Saccharomyces) and antiviral activity against certain enveloped viruses. The most pronounced bactericidal effect is observed against gram-positive bacteria (particularly Staphylococcus). In vivo studies with cetylpyridinium chloride have demonstrated antiviral activity; however, clinical relevance has not been established. Gram-negative bacteria are moderately sensitive to cetylpyridinium chloride, whereas certain strains of Pseudomonas are relatively resistant.

Pharmacokinetics.

Absorption

Of the two active substances, only benzidamine is absorbed; therefore, systemic pharmacokinetic interactions do not occur.

Evidence of benzidamine absorption through the oral and pharyngeal mucosa comes from serum concentrations detected, which are insufficient to produce systemic effects.

Distribution

When applied locally, benzidamine accumulates in inflamed tissues, where it reaches effective concentrations due to its ability to penetrate the epithelium.

Elimination

Elimination occurs mainly via urine, predominantly as inactive metabolites.

Clinical characteristics.

Indications.

Symptomatic treatment of infections of the throat and oral cavity (pharyngitis, laryngitis, gingivitis).

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.

Septolète® Total Lemon and Honey should not be used simultaneously with other antiseptics.

Lozenges should not be sucked together with milk due to its ability to reduce the antiseptic activity of cetylpyridinium chloride.

Special precautions for use

Sepsolète® Total Lemon and Honey should not be used for longer than 7 days. If there is no improvement within 3 days of treatment, consult a physician.

The use of topical agents, especially over a prolonged period, may lead to sensitization. In such cases, treatment should be discontinued and appropriate therapy initiated.

Sepsolète® Total Lemon and Honey should not be used in combination with anionic compounds present in toothpastes (as they reduce the efficacy of cetylpyridinium chloride). Therefore, it is not recommended to suck the lozenge immediately before or after tooth brushing.

The use of preparations containing benzidamine is not advisable for patients with increased sensitivity to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other nonsteroidal anti-inflammatory agents.

It is not recommended for use in the presence of oral wounds due to delayed healing caused by the action of cetylpyridinium chloride.

In cases of severe infections accompanied by high fever, headache, or vomiting, patients should seek medical advice, especially if there is no improvement within 3 days.

Bronchospasm may occur in patients with a history of bronchial asthma. This medicinal product should be used with caution in such patients.

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

Sepsolète® Total Lemon and Honey contains isomalt (E 953). This product should not be used in patients with rare hereditary disorders of galactose or fructose intolerance.

Sepsolète® Total Lemon and Honey contains sodium benzoate (E 211), which may moderately irritate the skin, eyes, and mucous membranes.

Use during pregnancy or breastfeeding

Pregnancy

Due to insufficient data on the use of the active ingredients in pregnant women, Sepsolète® Total Lemon and Honey is not recommended during pregnancy.

Period of breastfeeding

It is unknown whether benzidamine and its metabolites pass into breast milk; however, a risk to newborns and infants cannot be excluded. The decision on whether to discontinue breastfeeding or to discontinue therapy with Sepsolète® Total Lemon and Honey should be made by considering the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Effect on the ability to drive or operate machinery

Sepsolète® Total Lemon and Honey has no effect or only a negligible effect on the ability to drive or operate machinery.

Dosage and Administration

Adults and children aged 12 years and older are recommended to take 3–4 lozenges daily, slowly dissolving them in the mouth every 3–6 hours.

The adult dosage is recommended for elderly patients.

Children aged 6 to 12 years are recommended to take 3 lozenges daily, slowly dissolving them in the mouth every 3–6 hours.

Recommended doses should not be exceeded.

Septolete® Total Lemon and Honey may be used for up to 7 days.

Administration

The lozenge should be slowly dissolved in the mouth.

For optimal effect, the lozenge should not be taken immediately before or after tooth brushing.

Children

Use in children under 6 years of age is contraindicated due to the pharmaceutical form. Children aged 6–11 years should use the product under adult supervision.

Overdose

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

Symptoms

Toxic effects of benzidamine overdose include excitation, convulsions, sweating, ataxia, tremor, and vomiting. As there is no specific antidote, treatment of acute overdose is symptomatic.

Signs and symptoms of intoxication after ingestion of large doses of cetylpyridinium chloride include nausea, vomiting, dyspnea, cyanosis, asphyxia due to paralysis of respiratory muscles, central nervous system depression, arterial hypotension, and coma. The lethal dose for humans is approximately 1–3 g (which exceeds the maximum daily dose of Septolete® Total Lemon and Honey lozenges by 250–750 times).

Treatment

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

Adverse reactions

Very common: ≥ 1/10;

Common: ≥ 1/100 to < 1/10;

Uncommon: ≥ 1/1,000 to < 1/100;

Rare: ≥ 1/10,000 to < 1/1,000;

Very rare: < 1/10,000;

Not known: (cannot be estimated from the available data)

If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.

Report on expected adverse reactions

Reporting of adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance System at the following link: https://aisf.dec.gov.ua.

Shelf life.

4 years.

Storage conditions.

No special storage temperature requirements for this medicinal product. Store in the original packaging to protect from light. Keep out of reach of children.

Packaging.

8 lozenges per blister, 1, 2, 3, 4 or 5 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer.

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

Manufacturer's address and location of operations.

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