Faringosept with mint flavor

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARINGOSEPT WITH MINT TASTE (FARINGOSEPT with mint taste)

Composition:

Active substance: ambazone (ambazone);

1 compressed lozenge contains ambazone monohydrate 10 mg;

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

Pharmaceutical form. Compressed lozenges.

Main physico-chemical characteristics: compressed lozenges, brown in color, uncoated, uniformly cylindrical in shape, embossed with the letter "M" 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) most commonly causing 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 mint 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 Pharyngosept mint-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 medicinal product.

Patients with diabetes mellitus should take into account that the lozenges contain sucrose.

Since Pharyngosept mint-flavored lozenges contain sucrose, the product may be harmful to teeth.

Patients with diabetes are advised to avoid using this medicinal product due to its sucrose content. The energy 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 possibility of using Pharyngosept mint-flavored lozenges during pregnancy or breastfeeding should be determined by a physician, weighing the therapeutic benefit for the woman against the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery

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

Method of Administration and Dosage

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

The recommended dose for adults is 3–5 lozenges (30–50 mg ambazone) per day 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 meals (after 15–30 minutes), and food and drink should be avoided for the next 2–3 hours.

Increasing the recommended dose does not enhance the therapeutic effect.

Children

Do not use in children under 14 years of age.

Overdose

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

Adverse Reactions

Immune system

Hypersensitivity reactions are possible, including Quincke's edema, urticaria, itching, facial skin hyperemia, rash.

Gastrointestinal tract

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

Reporting of adverse reactions after drug registration is important. It enables ongoing 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 through 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 reach of children.

Packaging

10 lozenges per blister, 2 blisters per cardboard box.

Supply Category

Over-the-counter (without prescription).

Manufacturer

Terapia AT

Manufacturer's Address and Location of Business Activity

Str. Fabriciei, 124, 400632, Cluj-Napoca, Cluj County, Romania