STREPSILS® SUGAR FREE, WITH LEMON FLAVOUR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPSILS® SUGAR FREE, LEMON FLAVOUR (STREPSILS® LEMON SUGAR FREE)

Composition:

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

Each lozenge contains: 2,4-dichlorobenzyl alcohol 1.2 mg; amylopectin 0.6 mg;

Excipients:
lemon flavouring, tartaric acid, sodium saccharin, liquid maltitol, isomalt.

Pharmaceutical form.
Lozenges.

Main physicochemical characteristics:
Round lozenges, white to pale yellow in colour, with the letter "S" imprinted on both sides.

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

Pharmacological Properties.

Pharmacodynamics.

The drug has antiseptic properties. It is active against a broad spectrum of Gram-positive and Gram-negative microorganisms in vitro; it also exerts antifungal effects. The efficacy of the drug is due to the presence of two broad-spectrum antibacterial components, which help relieve throat pain and reduce inflammatory symptoms. Amylmetacresol disrupts the protein structure of bacteria, resulting in a bactericidal effect. 2,4-dichlorobenzyl alcohol exerts a bacteriostatic effect by dehydrating the bacterial cell.

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

Clinical characteristics.

Indications.

As an antiseptic agent for relief of sore throat pain.

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 symptoms persist for more than 3 days or worsen, or are accompanied by high fever, headache or other symptoms, consult a physician for further adjustment of the treatment regimen.

If you have known intolerance to certain sugars, consult your doctor before taking this medicinal product.

Isomalt and liquid maltitol contained in the product may cause a mild laxative effect (after use of several lozenges per day).

Not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding.

Pregnancy: data on the use of amylmetacresol and 2,4-dichlorobenzyl alcohol are lacking or limited. As with all medicinal products, caution should be exercised when using this medicine during pregnancy. If necessary, consult your doctor for advice.

Breastfeeding: It is unknown whether amylmetacresol, 2,4-dichlorobenzyl alcohol, or their metabolites pass into breast milk. A risk to newborns or infants who are breastfed cannot be excluded.

Data on the effect on fertility are lacking.

Ability to affect reaction speed when driving vehicles or operating machinery.

Studies on the influence on the ability to drive vehicles or operate machinery have not been conducted.

Method of Administration and Dosage

For oral use.

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

Adults and children aged 6 years and older are recommended to slowly dissolve one lozenge every 2–3 hours. The lozenge should be dissolved slowly until completely dissolved. Do not use more than 8 lozenges per day. The maximum recommended duration of use is 3 days. Dose adjustment is not required for elderly patients.

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

Overdose.
Accidental or intentional overdose may manifest only as gastrointestinal discomfort symptoms. In such a case, discontinue use of the medication and consult a physician. Treatment is symptomatic.

Side effects

The adverse reactions listed below were observed during 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 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1000; 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

Frequency not known: hypersensitivity reactions, which may include rash, angioneurotic edema, urticaria, bronchospasm, and hypotension with loss of consciousness.

Respiratory system and mediastinal organs

Frequency not known: pharyngeal edema (throat swelling).

Gastrointestinal tract

Frequency not known: sensation of discomfort in the oral cavity, which may include throat irritation, oral paresthesia (tingling in the mouth), swelling in the oral cavity, and glossodynia (painful tongue).

Frequency not known: dyspepsia, nausea, stomatitis, abdominal pain.

Skin and subcutaneous tissue

Frequency not known: skin rash, pruritus, erythema.

Shelf life.
3 years.

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

Packaging.
8 lozenges per blister, 2 blisters per cardboard box; 12 lozenges per blister, 1 or 2 blisters per cardboard box.

Prescription status.
Over-the-counter.

Manufacturer.
Reckitt Benckiser Healthcare International Limited.

Manufacturer's address and place of business.
Nottingham site, Tay Road, Nottingham, NG90 2DB, United Kingdom.