STREPSILS® FOR CHILDREN 6+

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Strepsils® Children 6+ (Strepsils® Children 6+)

Composition:

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

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

Excipients:
strawberry flavoring, anthocyanin (E 163), sodium saccharin (E 954), tartaric acid, maltitol liquid (E 965), isomalt (E 953).

Pharmaceutical form.
Lozenges.

Main physicochemical properties:
Pink round lozenge with a characteristic strawberry aroma, imprinted with the letter "S" on both sides.

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

Pharmacological properties.

Pharmacodynamics.

The medicinal product has antiseptic properties (active against a broad spectrum of Gram-positive and Gram-negative microorganisms), exerts antifungal effects, and possesses antiviral properties. The efficacy of the preparation is due to the presence of two antibacterial components with broad-spectrum activity, which 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. Both amylmetacresol and 2,4-dichlorobenzyl alcohol reversibly block ion channels similarly to local anesthetics, thus exhibiting analgesic properties.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.
As an antiseptic agent for the temporary relief of minor sore throat pain.

Contraindications.
Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Data not available.

Special precautions for use

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

This medicinal product should not be used in patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

The product contains isomalt and liquid maltitol, which may have a mild laxative effect if several doses are taken during the day.

Use during pregnancy or breastfeeding

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

Breastfeeding
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol, or their metabolites are excreted in human 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 Administration.

For oral use. Recommended for adults and children aged 6 years and older. Take 1 lozenge every 2–3 hours. Allow the lozenge to dissolve slowly in the mouth until completely dissolved. Recommended duration of use is 3 days. Do not exceed 8 lozenges within 24 hours. If symptoms persist or worsen, consult a physician for further treatment adjustment.

Dosage adjustment is not required for elderly patients.

Children.
Not recommended for 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 side effects were observed during short-term use of 2,4-dichlorobenzyl alcohol and amylmetacresol at over-the-counter doses. Other side effects may occur during treatment of chronic conditions or with prolonged use.

Side effects are classified by system organ class and frequency. Frequency is defined as follows: very common: ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1,000 and <1/100; rare: ≥1/10,000 and <1/1,000; 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 angioneurotic edema, which may involve swelling of the face, neck, throat, or tongue and may affect breathing.

Respiratory, thoracic and mediastinal disorders.

Uncommon: pharyngeal edema (swelling of the throat).

Gastrointestinal disorders.

Uncommon: oral discomfort (oral burning sensation), throat irritation (burning sensation in the throat), oral paresthesia (tingling sensation in the mouth), 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, erythema.

The product contains the colouring agent anthocyanin (E 163), which may cause allergic reactions.

Reporting of suspected adverse reactions.

It is important to report suspected adverse reactions during the post-marketing phase. This enables continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life.
2 years.

Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach and sight of children.

Packaging.
12 lozenges in a blister; 1 or 2 blisters in a cardboard box.

Prescription status.
Over-the-counter.

Manufacturer.
Reckitt Benckiser Healthcare International Limited.

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