Strepsils® with honey and lemon

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPSILS® WITH HONEY AND LEMON (STREPSILS® HONEY & LEMON)

Composition:

Active substances:
2,4-dichlorobenzyl alcohol, amylmetacresol;

One lozenge contains: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg;

Excipients:
honey, peppermint oil, lemon oil, tartaric acid, quinoline yellow (E 104), sucrose solution, glucose solution.

Pharmaceutical form.
Lozenges.

Main physicochemical properties:
Round yellow lozenges with the letter «S» embossed on both sides.

Pharmacotherapeutic group.
Preparations used in throat disorders. Antiseptics. ATC code: R02A A03.

Pharmacological Properties.

Pharmacodynamics.

2,4-dichlorobenzyl alcohol and amylmetacresol are antiseptics and possess antibacterial (bactericidal and bacteriostatic), antifungal, and antiviral properties demonstrated in vitro. When both active substances are combined in a single medicinal product, a synergistic antibacterial effect is observed, allowing for a reduction in the dosage required for the combination. In vitro studies have demonstrated the antimicrobial activity of the product against certain microorganisms causing sore throat, such as Streptococcus pyogenes, Staphylococcus aureus, Haemophilus influenzae, and Moraxella catarrhalis, within 1 minute of contact. A general reduction in bacterial load in the oral cavity was also observed in one in vivo study. In vitro studies have also shown antiviral activity of amylmetacresol and 2,4-dichlorobenzyl alcohol, as well as their combination, against enveloped viruses, including influenza virus A, parainfluenza virus, respiratory syncytial virus, cytomegalovirus, and coronavirus, within 1–2 minutes of contact.

Data from clinical trials demonstrate that Strepsils® Honey and Lemon lozenges reduce sore throat pain and provide relief from painful and difficult swallowing, with onset of action occurring within 5 minutes and duration of effect lasting up to 2 hours. Significantly greater symptom relief compared to placebo lozenges without active ingredients has also been demonstrated over treatment periods of up to 3 days. In one study, Strepsils® Honey and Lemon lozenges were also shown to significantly reduce postoperative sore throat and hoarseness at 20 minutes and 24 hours after intubation. A study involving children (aged 6–16 years) with acute and recurrent chronic sore throat demonstrated a reduction in both subjective and objective signs of sore throat within 3 days of treatment with Strepsils® Honey and Lemon lozenges.

Strepsils® Honey and Lemon lozenges contain lemon oil, peppermint oil, and honey, which exert a soothing effect and help calm the irritated throat.

Pharmacokinetics.

2,4-dichlorobenzyl alcohol is metabolized in the liver to form hippuric acid, which is excreted in the urine. Data on the metabolism and elimination of amylmetacresol are not available.

Clinical characteristics.

Indications.

Symptomatic treatment of infectious and inflammatory diseases of the oral cavity and pharynx.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions.

No known interactions.

Special precautions for use.

Do not exceed the stated maximum dose.

If symptoms persist for more than 3 days, consult a physician for further adjustment of the treatment regimen.

This medicinal product should not be used in patients with hereditary rare disorders associated with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. Diabetic patients should be aware that 1 lozenge contains approximately 2.6 g of sugar.

Use during pregnancy or breastfeeding.

Pregnancy.
Data on the use of amylmetacresol and 2,4-dichlorobenzyl alcohol during pregnancy are lacking or limited. As with all other medicinal products, caution should be exercised when using this medicine during pregnancy, and medical advice should be sought if necessary.

Breastfeeding.
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol, or their metabolites pass into breast milk. A risk to newborns/infants cannot be ruled out.

Fertility.
Data on the effect on fertility are lacking.

Ability to affect reaction speed when driving or operating machinery.

The effect on the ability to drive or operate machinery is absent or negligible.

Dosage and Administration.

For oromucosal use.

Use the lowest effective dose necessary to relieve symptoms for the shortest possible duration.

Recommended for adults and children aged 6 years and older: one lozenge every 2–3 hours. The lozenge should be slowly dissolved in the mouth until completely dissolved. Do not use more than 12 lozenges within 24 hours. If symptoms do not improve or worsen within 3 days, consult a physician.

Dosage adjustment is not required for elderly patients.

Children.
Due to the pharmaceutical form, the medicinal product is contraindicated in children under 6 years of age.

Overdose.

In the unlikely event of overdose, serious adverse effects are not expected. Some gastrointestinal discomfort may occur. Treatment is symptomatic.

Side effects

The following adverse reactions have been observed with short-term use of 2,4-dichlorobenzyl alcohol and amylmetacresol at over-the-counter doses. Other adverse reactions may occur during treatment of chronic conditions or with prolonged use.

Adverse reactions are classified by system organ class and frequency. Frequency is defined as follows: 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; frequency not known (cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

Immune system disorders

Uncommon: hypersensitivity reactions, including rash, urticaria, and angioneurotic edema, which may involve swelling of the face, neck, throat, or tongue and may affect breathing.

Respiratory, thoracic and mediastinal disorders

Uncommon: pharyngeal swelling (throat swelling).

Gastrointestinal disorders

Uncommon: oral discomfort (oral burning sensation), throat irritation (throat burning), oral paraesthesia (oral tingling), oral swelling. Rare: glossodynia (painful tongue). Very rare: dyspepsia, nausea, stomatitis. Frequency not known: abdominal pain.

Skin and subcutaneous tissue disorders

Frequency not known: skin rash, pruritus, erythema.

Shelf life
2 years.

Storage conditions
Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging
12 lozenges in a blister; 2 blisters in a cardboard box.

Prescription status
Over-the-counter (without prescription).

Manufacturer
Reckitt Benckiser Healthcare International Limited / Reckitt Benckiser Healthcare International Limited.

Manufacturer's address and place of business
Nottingham Site, Thane Road, Nottingham, NG90 2DB, United Kingdom / Nottingham Site, Thane Road, Nottingham, NG90 2DB, United Kingdom.