Strepsils® with menthol and eucalyptus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPSILS® WITH MENTHOL AND EUCALYPTUS (STREPSILS® MENTHOL & EUCALYPTUS)

Composition:

Active substances:
2,4-dichlorobenzyl alcohol; amylobarbitone cresol; levomenthol;

1 lozenge contains: 2,4-dichlorobenzyl alcohol 1.2 mg; amylobarbitone cresol 0.6 mg; levomenthol 8 mg;

Excipients:
eucalyptus oil, tartaric acid, indigocarmine (E 132), sucrose solution, glucose solution.

Pharmaceutical form.
Lozenges.

Main physico-chemical characteristics:
Round blue lozenges with the embossed letter "S" on both sides.

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

Pharmacological Properties

Pharmacodynamics

The product has antiseptic properties. It is active against a broad spectrum of gram-positive and gram-negative microorganisms and exerts antifungal effects. The efficacy of the product is due to the presence of two antibacterial components with broad-spectrum activity, which help relieve sore throat pain.

Menthol exerts a mild local anesthetic effect on the mucous membrane of the throat and also reduces symptoms of cough and nasal congestion. Levomenthol and eucalyptus oil reduce swelling of the mucous membranes of the oropharynx and nasopharynx.

Pharmacokinetics

Due to negligible absorption into the bloodstream, the product is classified as a locally acting agent. Because of this, pharmacokinetic parameters have not been determined.

Clinical characteristics.

Indications.

Symptomatic treatment of infectious and inflammatory diseases of the oral cavity and throat; early symptoms of cold accompanied by sore throat and nasal congestion.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions.

Interaction studies have not been conducted.

Special precautions for use

Do not exceed the stated maximum dose.

If there is no improvement or if symptoms worsen within 3 days of using the medicine, consult a doctor for further adjustment of the treatment regimen.

This medicine should not be used in patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. Diabetic patients should be aware that one lozenge contains approximately 2.6 g of sugar.

Strepsils® with Menthol and Eucalyptus should not be used by diabetic patients.

Use during pregnancy or breastfeeding.

Pregnancy
Data on the use of amylohexylresorcinol 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, amylohexylresorcinol, or their metabolites pass into breast milk. A risk to newborns/infants cannot be excluded.

Fertility
There are no data available on the effect on fertility.

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 method of administration.

For oromucosal use.

The medicine should be used at the lowest effective dose for the shortest duration necessary to control symptoms.

Recommended for adults and children aged 6 years and older: one lozenge every 2–3 hours. The lozenge must be slowly dissolved until completely dissolved. Do not use more than 12 lozenges within 24 hours. The maximum recommended duration of treatment is 3 days. Dose adjustment is not required for elderly patients.

Children.

Due to the pharmaceutical form, the medicine 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 organ systems and frequency. Frequency is defined as follows: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000; 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 angioedema, which may involve swelling of the face, neck, throat, or tongue and may affect breathing; bronchospasm, anaphylaxis, erythema.

Respiratory, thoracic and mediastinal disorders.

Uncommon: pharyngeal swelling (throat swelling).

Gastrointestinal disorders.

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

Skin and subcutaneous tissue disorders.

Not known: skin rash, pruritus, urticaria, erythema.

Shelf life.
3 years.

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

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

Availability category.
Over-the-counter.

Manufacturer.
Reckitt Benckiser Healthcare Limited.

Manufacturer's address.
Nottingham site, Taylors Road, Nottingham, NG90 2DB, United Kingdom.