FARINGOSEPT WITH CINNAMON FLAVOR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARYNGOSEPT WITH CINNAMON TASTE (FARINGOSEPT with cinnamon taste)

Composition:

Active ingredient: ambazone;

One compressed lozenge contains 10 mg of ambazone monohydrate;

Excipients: sucrose; lactose monohydrate; cocoa; povidone K-30; stearic acid; cinnamon flavoring.

Pharmaceutical form. Compressed lozenges.

Main physicochemical properties: compressed lozenges, brown in color, uncoated, uniformly cylindrical in shape, embossed with the letter "C" on one side and smooth on the other, with intact edges and pigmented surface.

Pharmacotherapeutic group

Preparations used in throat diseases. Antiseptics. Ambazone.

ATC code R02A A01.

Pharmacological Properties

Pharmacodynamics

Ambazon is a local antiseptic with high activity against pathogenic microorganisms (streptococci, pneumococci) that most commonly cause infections of the oral cavity and upper respiratory tract, as well as having moderate anti-staphylococcal activity. It does not affect intestinal microflora and therefore does not cause gastrointestinal dysbiosis.

In addition, the use of compressed lozenges increases salivation and the release of the body's natural bactericidal substances (such as lysozyme), thus moisturizing the mucous membrane and reducing irritation.

Pharmacokinetics

Information on the pharmacokinetics of Pharyngosept with cinnamon flavor is unavailable.

Clinical characteristics

Indications

Used as an adjunctive agent in the treatment of infections of the mucous membranes of the oral cavity and nasopharynx: gingivitis, tonsillitis, pharyngitis. Prevention of infectious complications after tonsillectomy.

Contraindications

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction

To date, no interactions of the drug with any other medicinal products have been reported.

Special precautions for use

Since Pharingosept cinnamon-flavored lozenges contain sucrose and lactose, patients with rare hereditary forms of fructose or galactose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency, or Lapp lactase deficiency should avoid using this product.

Since Pharingosept cinnamon-flavored lozenges contain sucrose, the product may be harmful to teeth.

Patients with diabetes mellitus are advised to avoid using this medicinal product due to its sucrose content. The caloric value of sucrose is similar to that of lactose: 3.94 kcal/g (16.5 kJ/g).

Use during pregnancy or breastfeeding

There are no controlled clinical studies on the use of ambazone during pregnancy or breastfeeding. However, there have been no reports of adverse reactions or harmful effects on the fetus following ambazone use during pregnancy. It is unknown whether ambazone passes into breast milk.

The decision to use Pharingosept cinnamon-flavored lozenges during pregnancy or breastfeeding should be made by a physician, taking into account that the therapeutic benefit to the woman must outweigh the potential risk to the fetus/infant.

Ability to affect reaction speed when driving or operating machinery

The product does not affect the ability to drive or operate machinery.

Dosage and Administration

The recommended dose for children aged 14–18 years is 1 lozenge 3 times daily (30 mg ambazone) for 3–4 days.

The recommended dose for adults is 3–5 lozenges (30–50 mg ambazone) daily for 3–4 days. The lozenges must not be swallowed; they should be slowly dissolved in the mouth until completely dissolved. The drug is usually taken immediately after eating (15–30 minutes after a meal); food and drink should be avoided for 2–3 hours after administration.

Increasing the recommended dose does not improve the therapeutic effect.

Children

Do not use in children under 14 years of age.

Overdose

No cases of overdose have been reported to date. There is no specific antidote. In case of ingestion of a very large number of Cinnamon-flavored Pharingosept lozenges, it is recommended to induce vomiting and/or perform gastric lavage.

Side effects

Immune system

Hypersensitivity reactions are possible, including angioedema, urticaria, pruritus, facial skin hyperemia, rash.

Gastrointestinal tract

One case of saliva discoloration has been reported in a patient taking ambazon.

Reporting of adverse reactions following marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life

2 years.

Storage conditions

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

Keep out of the reach of children.

Packaging

10 lozenges in a blister, 2 blisters in a cardboard box.

Supply classification

Over-the-counter.

Manufacturer

Terapia AT/Terapia S.A.

Manufacturer's address and location of its business operations

Str. Fabriciei, No. 124, 400640, Cluj-Napoca, Cluj County, Romania.