FARINGOSEPT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARINGOSEPT (FARINGOSEPT)

Composition:

Active substance: ambazone;

1 compressed lozenge contains ambazone monohydrate 10 mg;

Excipients: sucrose, lactose monohydrate, cocoa, povidone K-30, stearic acid, vanillin.

Pharmaceutical form. Compressed lozenges.

Main physicochemical properties: brown, uncoated, cylindrical compressed lozenges with intact edges, flat, with 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 most commonly causing infections of the oral cavity and upper respiratory tract: streptococci, pneumococci, as well as having moderate anti-staphylococcal activity. It does not affect intestinal microflora; therefore, it does not cause gastrointestinal dysbiosis.

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

Clinical characteristics.

Indications.

Symptomatic treatment of infections of the mucous membranes of the oral cavity and nasopharynx: gingivitis, stomatitis, tonsillitis, angina, pharyngitis. Prevention of infectious complications after tonsillectomy and tooth extraction.

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 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 the drug. Diabetic patients should take into account that the lozenges contain sucrose.

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.

Pharingosept lozenges may be prescribed during pregnancy or breastfeeding only if, in the opinion of the physician, the therapeutic benefit to the mother outweighs the potential risk to the fetus.

Ability to influence reaction rate when driving or operating machinery.

The drug does not affect the ability to drive vehicles or operate complex machinery.

Method of Administration and Dosage.

The recommended dose of the drug for adults and children aged 7 years and older is 3 to 5 lozenges (30–50 mg of ambazon) per day for at least 3–4 days. The lozenges should not be swallowed; they should be slowly dissolved in the mouth by saliva. The drug is usually taken immediately after eating (after 15–30 minutes), and food and drink should be avoided for 2–3 hours afterwards.

The recommended dose for children aged 3–7 years is 1 lozenge 3 times daily (30 mg of ambazon per day) for 3–4 days.

Increasing the recommended dose does not enhance the therapeutic effect.

Children.

Do not use in children under 3 years of age.

Overdose.

Cases of overdose have not been reported to date. There is no specific antidote. If a very large number of Pharingosept lozenges are taken, it is recommended to induce vomiting and/or perform gastric lavage.

Side effects.

Possible hypersensitivity reactions, including Quincke's edema, urticaria, itching, facial skin hyperemia, rash.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

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

Supply category.

Over-the-counter.

Manufacturer.

Terapia AT

Manufacturer's location and address of business activity.

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