Neo-angin® sugar free

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEО-ANGIN® SUGAR FREE (NEO-ANGIN® SUGAR FREE)

Composition:

Active substances:

1 lozenge contains 2.4-dichlorobenzyl alcohol 1.2 mg, amylmetacresol 0.6 mg, levomenthol 5.72 mg;

Excipients: star anise oil, peppermint oil, Ponceau 4R dye (E 124), isomalt, tartaric acid.

Pharmaceutical form. Lozenges.

Main physico-chemical characteristics: round, red, slightly biconvex, slightly transparent lozenges with a characteristic odour and pleasant taste.

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

Pharmacological properties.

Pharmacodynamics.

Neo-Angin® sugar free is active against a broad spectrum of gram-positive and gram-negative microorganisms in vitro; it demonstrates antifungal activity. The efficacy of the preparation is due to the presence of two broad-spectrum antibacterial components, which help relieve sore throat 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 of the preparation 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 types of interactions.

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 drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Dosage and Administration

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

3–4 days.

Children.

Sugar-free Neo-Angin® is contraindicated for children under 6 years of age.

Overdose.

No cases of overdose have been reported.

Side effects.

The following categories are used to assess the frequency 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 the 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.

Isomalt and the dye Ponceau 4R (E 124) may cause allergic reactions.

Shelf life. 5 years.

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

Packaging. 2 blisters of 8 lozenges or 2 blisters of 12 lozenges or 4 blisters of 12 lozenges in cardboard boxes.

Classification. Over-the-counter (available without prescription).

Manufacturers.

Divapharma GmbH
Klosterfrau Berlin GmbH

Manufacturer's address and place of business:

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