NEO-ANGIN® CHERRY

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEO-ANGIN® Cherry

Composition:

Active substances: 1 lozenge contains 2,4-dichlorobenzyl alcohol 1.2 mg; amylometacresol 0.6 mg; levomenthol 5.9 mg;

Excipients: peppermint oil, isomalt, tartaric acid, cherry flavor, Ponceau 4R (E 124), indigocarmine (E 132).

Pharmaceutical form. Lozenges.

Main physicochemical characteristics: round, red-colored, biconvex, slightly transparent lozenges, possibly with a white coating.

Pharmacotherapeutic group.

Preparations used for throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

Neo-Angin® Cherry is active against a broad spectrum of Gram-positive and Gram-negative microorganisms in vitro and exhibits antifungal activity. The efficacy of the preparation is due to the presence of two broad-spectrum antibacterial components that help relieve throat pain and reduce bacterial activity, resulting in a bactericidal effect. 2,4-dichlorobenzyl alcohol exerts a bacteriostatic effect by dehydrating the bacterial cell.

Levomenthol complements the action of the other two components of the preparation with an analgesic effect caused by stimulation of cold receptors in the mucous membrane.

Neo-Angin® Cherry is well tolerated and has a pleasant taste.

Pharmacokinetics.

Due to negligible absorption, the preparation is considered a locally acting agent. For this reason, pharmacokinetic parameters have not been determined.

Clinical characteristics.

Indications.

For supportive treatment of inflammatory conditions of the pharyngeal mucosa associated with symptoms such as sore throat, redness, or swelling. The product is indicated for adults and children aged 6 years and older.

Contraindications.

Hypersensitivity to 2,4-dichlorobenzyl alcohol, amylmetacresol, levomenthol, peppermint oil, Ponceau 4R (E 124), or any other excipient of the medicinal product.

Contraindicated in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

With oral administration, relevant medicinal interactions are unknown.

Special precautions for use.

One lozenge contains isomalt (a sugar substitute, E 953), providing 6 kcal (26 kJ). This should be taken into account by patients with diabetes mellitus.

The drug should not be used in patients with hereditary fructose intolerance.

Isomalt may have a mild laxative effect.

If fever or bacterial streptococcal throat infection occurs, or if symptoms persist for more than 3 days and/or the general condition worsens, immediate medical advice should be sought to adjust the treatment regimen.

Use during pregnancy or breastfeeding.

There are no data on the use of Neo-Angin® Cherry during pregnancy or breastfeeding. Neo-Angin® Cherry is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Dosage and Administration.

For adults and children aged 6 years and older, the product is recommended to be slowly dissolved at a rate of 1 lozenge every 2–3 hours, but not more than 6 lozenges per day. The duration of treatment should be determined individually by a physician; however, it is generally not recommended to use the product for longer than 3–4 days.

Children.

Contraindicated for children under 6 years of age.

Overdose.

Symptoms: gastrointestinal discomfort may occur. Treatment is symptomatic.

Adverse reactions.

Adverse reactions are classified by system organ 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)

Frequency not known (cannot be estimated from available data)

Immune system disorders:

Very rare: hypersensitivity reactions to any of the components.

Frequency not known: ponc 4R and benzyl alcohol may cause allergic reactions. In susceptible sensitized patients, hypersensitivity reactions (skin hyperemia, itching, skin rash, urticaria, angioneurotic edema, swelling and pain of lips, tongue or throat, including respiratory distress) may be caused by levomenthol and peppermint oil.

Gastrointestinal disorders:

Very rare: irritation of the oral and gastric mucosa, stomatitis, burning, stinging or pain in the mouth, glossitis, glossodynia.

Frequency not known: dyspepsia, nausea, vomiting.

Shelf life. 4 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

12 lozenges in a blister. 2 blisters in a cardboard package.

Pharmaceutical category. Over-the-counter.

Manufacturer.

Divapharma GmbH, Germany

Manufacturer's address and place of business.

Mötzener Strasse 41, 12277 Berlin, Germany.