NEO-ANGIN® SAGE

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

Composition:

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

Excipients: peppermint oil, isomalt, tartaric acid, sage oil, Ponceau 4R (E 124), quinoline yellow (E 04), patent blue V (E 131).

Pharmaceutical form. Lozenges.

Main physicochemical properties: round, honey-colored, biconvex, slightly transparent lozenges; a white coating may be present.

Pharmacotherapeutic group.

Preparations used in throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

"Neo-Angin® Sage" is active against a broad spectrum of Gram-positive and Gram-negative microorganisms in vitro; it also exhibits antifungal activity. The efficacy of the medicinal product is due to the presence of two broad-spectrum antibacterial components, which 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® Sage" 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 the supportive treatment of inflammatory processes of the pharyngeal mucosa accompanied by symptoms such as sore throat, redness, or swelling. The medicinal 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 dye (E 124), or any other excipient of the medicinal product.

Contraindicated in infants and children under 6 years of age (due to the presence of levomenthol).

Interaction with other medicinal products and other forms of interactions.

When administered orally, relevant drug interactions are unknown.

Special precautions for use.

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

The medicinal product should not be used in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Isomalt may have a mild laxative effect.

If symptoms such as fever, bacterial streptococcal throat infection, and/or worsening of general condition persist for more than 3 days, immediate medical advice should be sought, as systemic antibiotic therapy may be required.

Use during pregnancy or breastfeeding.

There are no data on the use of the medicinal product "Neo-Angin® Sage" during pregnancy or lactation.

The medicinal product "Neo-Angin® Sage" is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Method of administration and dosage.

For adults and children aged 6 years and older, it is recommended to slowly dissolve 1 lozenge every 2–3 hours, but not more than 6 lozenges per day.

The medicinal product "Neo-Angin® Sage" should not be used for longer than 3–4 days without medical advice.

Children.

Contraindicated in children under 6 years of age.

Overdose.

Symptoms: gastrointestinal discomfort may occur. Treatment is symptomatic.

Side effects.

Side effects are classified by system organ class and frequency. Frequency is defined as follows:

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);

frequency not known (cannot be estimated from available data)

Immune system disorders:

Very rare: hypersensitivity reactions to any of the components.

Frequency not known: Ponceau 4R (E 124) 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 triggered by levomenthol and peppermint oil.

Gastrointestinal disorders:

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

Frequency not known: dyspepsia, nausea, vomiting.

Shelf life. 4 years.

Storage conditions.

Store in the 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.

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

Manufacturer.

Divapharma GmbH, Germany.

Manufacturer's address and place of business.

Mötzener Strasse 41, 12277 Berlin, Germany.