Strepsils® with vitamin c with orange flavour

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Strepsils® with Vitamin C, Orange Flavour (Strepsils® Orange with Vitamin C)

Composition:

Active substances:
2,4-dichlorobenzyl alcohol, amylenmetacresol, sodium ascorbate, ascorbic acid;

Each lozenge contains: 2,4-dichlorobenzyl alcohol 1.2 mg; amylenmetacresol 0.6 mg; sodium ascorbate 74.9 mg; ascorbic acid 33.5 mg;

Excipients:
levomenthol, orange flavour, propylene glycol, sunset yellow FCF (E 110), Ponceau 4R (E 124), tartaric acid, sucrose solution, glucose solution.

Pharmaceutical form.
Lozenges.

Main physicochemical properties:
Orange-coloured round lozenges with the letter "S" imprinted on both sides.

Pharmacotherapeutic group.
Preparations used in throat diseases. Antiseptics. Dichlorobenzyl alcohol. ATC code R02AA03.

Pharmacological properties.

Pharmacodynamics.

The drug has antiseptic properties and is active against a broad spectrum of gram-positive and gram-negative microorganisms; it also exerts antifungal effects. The efficacy of the drug is due to the presence of two broad-spectrum antibacterial components that help relieve throat pain and reduce inflammatory symptoms. Amylmetacresol disrupts the protein structure of bacteria, providing a bactericidal effect. 2,4-Dichlorobenzyl alcohol exerts a bacteriostatic effect by dehydrating the bacterial cell. Ascorbic acid compensates for the increased demand of the body for vitamin C during infectious and inflammatory diseases.

Pharmacokinetics.

Due to negligible absorption into the bloodstream, the drug belongs to locally acting agents. Because of this, pharmacokinetic parameters have not been determined.

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 forms of interaction.

Interaction studies have not been performed.

Special precautions for use.

Do not exceed the recommended 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 rare hereditary diseases associated with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. Diabetic patients should take into account that one lozenge contains 1 g of glucose and 1.4 g of sucrose.

Use with caution in patients with thrombosis, predisposition to thrombosis, thrombophlebitis, severe kidney diseases, or urolithiasis, as the product contains ascorbic acid.

The medicinal product contains the colorants Sunset Yellow FCF (E 110) and Ponceau 4R (E 124), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Pregnancy.
The safety of using the product during pregnancy or breastfeeding has not been fully established; however, the occurrence of risk during these periods is not expected. Nevertheless, as with all medicinal products, caution should be exercised during pregnancy or breastfeeding.

Breastfeeding.
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol, or their metabolites are excreted in breast milk. A risk to newborns/infants cannot be excluded.

Data on effects on fertility are lacking.

Ability to influence reaction speed when driving or operating machinery.
The influence on the ability to drive or operate machinery is absent or negligible.

Method of administration and dosage.

For oromucosal use.

Use the lowest effective dose required to relieve symptoms for the shortest duration of time.

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 amylmetacresol and 2,4-dichlorobenzyl alcohol. 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: ≥ 1/10000 and < 1/1000; very rare: < 1/10000; unknown (cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

From the immune system.

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

From the respiratory tract and mediastinal organs.

Uncommon: pharyngeal edema (throat swelling).

From the gastrointestinal tract.

Uncommon: discomfort in the oral cavity (oral burning sensation), throat irritation (throat burning sensation), oral paresthesia (tingling sensation in the mouth), oral swelling. Rare: glossodynia (painful tongue). Very rare: dyspepsia, nausea, stomatitis. Unknown: abdominal pain.

From the skin and subcutaneous tissue.

Unknown: skin rash, pruritus, erythema.

Shelf life.

3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

12 lozenges per blister pack; 2 blister packs in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Reckitt Benckiser Healthcare International Limited.

Manufacturer's location and address of place of business.

Nottingham site, Taylors Road, Nottingham, NG90 2DB, United Kingdom.