Neo-angin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEО-ANGIN® (NEO-ANGIN®)

Composition:

Active substances:

1 lozenge contains 2,4-dichlorobenzyl alcohol 1.2 mg, amylmetacresol 0.6 mg, levomenthol 5.9 mg;

Excipients: star anise oil, peppermint oil, Ponceau 4R (E 124), sucrose, glucose syrup, tartaric acid.

Pharmaceutical form. Lozenges.

Main physicochemical properties: round, red, slightly biconvex, slightly transparent lozenges with a characteristic odor and pleasant taste.

Pharmacotherapeutic group. Preparations used in throat disorders. Combined antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

Neo-Angin**®** is active against a broad spectrum of gram-positive and gram-negative microorganisms in vitro; it also 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 effects through a bactericidal action. 2,4-dichlorobenzyl alcohol exerts a bacteriostatic effect by dehydrating the bacterial cell.

Levomenthol complements the action of the other two components with an analgesic effect resulting from stimulation of cold receptors in the mucous membrane.

Pharmacokinetics.

Pharmacokinetic parameters have not been determined.

Clinical characteristics.

Indications. Local treatment (as part of combination therapy) of infectious and inflammatory diseases of the oral cavity, pharynx, and larynx: stomatitis, gingivitis, tonsillitis, early stage of angina, pharyngitis, laryngitis.

Contraindications.

• Hypersensitivity to 2,4-dichlorobenzyl alcohol, amylmetacresol, levomenthol, Ponceau 4R dye, or any other excipient of the medicinal product;
• children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

If symptoms persist for more than 3 days, are accompanied by high fever, headache or other manifestations, consult a physician to adjust the treatment regimen.

The product is contraindicated in patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

One lozenge contains 1.14 g of glucose and 1.42 g of sucrose (sugar), which corresponds to approximately 0.22 bread units (BU).

This should be taken into account by patients with diabetes mellitus.

Frequent use of Neo-Angin® lozenges may be harmful to teeth (caries).

The dye Ponceau 4R may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are no data available on the safety of Neo-Angin**®** during pregnancy and breastfeeding. Reproductive toxicity studies of this medicinal product in animals have not been conducted. Neo-Angin**®** should not be used during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

For adults and children aged 6 years and older, Neo-Angin® should be slowly dissolved, one lozenge every 2–3 hours, but not more than 6 lozenges per day. The duration of treatment is 3–4 days.

Children.

Neo-Angin® is contraindicated for use in children under 6 years of age.

Overdose.

Cases of overdose have not been reported.

Side effects.

The following frequency categories are used to assess the incidence of adverse reactions:

Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥ 1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from available data)

Immune system disorders.

Not known: hypersensitivity reactions, including rash, urticaria, pruritus, anaphylaxis, erythema.

Respiratory, thoracic and mediastinal disorders.

Not known: pharyngeal edema (throat swelling), bronchospasm.

Gastrointestinal disorders.

Very rare: irritation of the oral and gastric mucosa, sensation of discomfort in the mouth (oral burning), throat irritation (throat burning), oral paresthesia (tingling in the mouth), glossodynia (painful tongue).

Very rare: dyspepsia, nausea, stomatitis.

Not known: abdominal pain.

The dye Ponceau 4R (E 124) may cause allergic reactions.

Shelf life. 3 years.

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

Packaging. 12 lozenges in a blister; 2 or 4 blisters in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturers.

Divapharma GmbH.

(Batch release).

Klosterfrau Berlin GmbH.

(Manufacturing, analytical testing, primary and secondary packaging).

Manufacturers' addresses:

Divapharma GmbH:
Motzener Strasse 41, 12277 Berlin, Germany.

Klosterfrau Berlin GmbH:
Motzener Strasse 41, 12277 Berlin, Germany.

Marketing authorization holder.

Divapharma GmbH.

Address of the marketing authorization holder:
Motzener Strasse 41, 12277 Berlin, Germany.