Septolète® total lemon and elderberry

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

Composition:

Active substances: benzidamine hydrochloride, cetylpyridinium chloride;

1 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 (containing butylated hydroxyanisole (E 320)), elderflower flavor (containing propylene glycol), colorant curcumin (containing sodium benzoate (E 211)), copper complex of chlorophyllin colorant (containing propylene glycol).

Pharmaceutical form. Lozenges.

Main physicochemical characteristics: round lozenges with beveled edges and uneven surface, pale green to green in color, with possible white spots, uneven coloring, air bubbles, and slightly jagged edges.

Pharmacotherapeutic group. Preparations for the throat. Antiseptics. ATC code R02A A20.

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 group of quaternary ammonium compounds. 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, as well as antifungal activity (e.g., against Candida and Saccharomyces) and antiviral activity against certain enveloped viruses. The bactericidal effect is most pronounced against gram-positive bacteria (particularly Staphylococcus). 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 absorption of benzidamine through the oral and pharyngeal mucosa comes from plasma concentrations detected in blood serum, which are insufficient to produce a systemic effect.

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 primarily via urine, mostly in the form of inactive metabolites.

Clinical characteristics.

Indications.

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

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 interactions.

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

The lozenges should not be sucked together with milk, due to milk's ability to reduce the antiseptic activity of cetylpyridinium chloride.

Special precautions for use

Do not use Septolete® Total Lemon and Elderberry for longer than 7 days. If there is no improvement within 3 days of treatment, consult a physician.

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

Do not use Septolete® Total Lemon and Elderberry in combination with anionic compounds present in toothpastes (as they reduce the effectiveness 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 in patients with hypersensitivity to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other nonsteroidal anti-inflammatory drugs.

Avoid use in the presence of oral wounds due to delayed healing caused by cetylpyridinium chloride.

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

Bronchospasm may occur in patients with a history of bronchial asthma. Exercise caution when using the medicinal product in such patients.

If a patient suffers from chronic cough or hoarseness, consult a physician.

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

Septolete® Total Lemon and Elderberry contains butylated hydroxyanisole (E 320), which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

Septolete® Total Lemon and Elderberry contains sodium benzoate (E 211), which may mildly irritate the skin, eyes, and mucous membranes.

Septolete® Total Lemon and Elderberry contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

Pregnancy

Due to insufficient data on the use of the active ingredients, Septolete® Total Lemon and Elderberry is not recommended during pregnancy.

Breastfeeding period

It is unknown whether benzidamine and its metabolites are excreted in breast milk; however, a risk to newborns and infants cannot be excluded. The decision to discontinue breastfeeding or to refrain from using Septolete® Total Lemon and Elderberry should be made after considering the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Effect on the ability to drive vehicles or operate machinery

Septolete® Total Lemon and Elderberry has no effect or a negligible effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

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

For elderly patients, the adult dosage is recommended.

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

Recommended doses should not be exceeded.

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

Method of Administration

The lozenge should be slowly dissolved in the mouth.

To achieve 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 medication under adult supervision.

Overdose

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

Symptoms

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

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, central nervous system depression, arterial hypotension, and coma. The lethal dose in humans is approximately 1–3 g (which exceeds the maximum daily dose of Septolète® Total Lemon and Elderberry lozenges by 250–750 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;
Not known: (cannot be estimated from available data).

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

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Information on any suspected adverse reactions should be reported in accordance with the requirements of legislation.

Shelf life.

4 years.

Storage conditions.

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

Packaging.

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

Classification. Over-the-counter (without prescription).

Manufacturer.

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

Address of the manufacturer and location of operations.

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