Pharngosept with rum flavour

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARINGOSEPT WITH RUM TASTE (FARINGOSEPT WITH RUM TASTE)

Composition:

Active substance: ambazone;

One compressed lozenge contains ambazone monohydrate 10 mg;

Excipients: sucrose; lactose monohydrate; cocoa; povidone K-30; stearic acid; rum flavor.

Pharmaceutical form. Compressed lozenges.

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

Pharmacotherapeutic group.

Preparations used in throat disorders. 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 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 Pharingosept with rum flavor is unavailable.

Clinical characteristics.

Indications.

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 medicinal product.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

Since Pharingosept lozenges with rum flavor contain sucrose and lactose, patients with rare hereditary forms of fructose intolerance, galactose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency, or Lapp lactase deficiency should avoid using the drug.

Since Pharingosept lozenges with rum flavor contain sucrose, the product may be harmful to teeth.

Patients with diabetes mellitus should 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 ambazon during pregnancy or breastfeeding. However, there have been no reports of adverse reactions or harmful effects on the fetus following ambazon use during pregnancy. It is unknown whether ambazon passes into breast milk.

Pharingosept lozenges with rum flavor are not recommended for use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

The drug does not affect the ability to drive vehicles or operate complex machinery. However, since the formulation contains rum flavoring, its use by drivers is not recommended.

Method of Administration and Dosage.

The recommended dose of the drug for adults is 3 – 5 lozenges (30 – 50 mg of ambazone) per day for 3 – 4 days. The lozenges must not be swallowed but should be slowly dissolved in the mouth until completely dissolved. The drug is usually taken immediately after eating (after 15 – 30 minutes), and food and drink should be avoided for 2 – 3 hours afterwards.

Increasing the recommended dose does not improve the therapeutic effect.

Children.

Do not use in children under 18 years of age.

Overdose.

Cases of overdose have not been reported to date. There is no specific antidote. In the event of ingestion of a very large number of rum-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 (angioedema), urticaria, pruritus, facial skin hyperemia, and rash.

Gastrointestinal tract

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

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Information System for Pharmacovigilance 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.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Terapia AT

Manufacturer's address and location of its business operations.

124 Fabriciei Street, Cluj-Napoca, 400632, Cluj County, Romania