Tantum rosa®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TANTUMROSA®

Composition:

Active substance: benzidamine hydrochloride;

100 ml of solution contain 100 mg of benzidamine hydrochloride;

Excipients: benzalkonium chloride, disodium edetate, ethanol 96%, polysorbate 20, rose oil, purified water.

Pharmaceutical form. Vaginal solution.

Main physicochemical properties: colorless clear liquid with a characteristic rose odor.

Pharmacotherapeutic group. Anti-inflammatory agents for vaginal use.

ATC code G02CC03.

Pharmacological Properties.

Pharmacodynamics.

Benzidamine is a non-steroidal anti-inflammatory agent with analgesic and anti-edematous properties. When applied locally, it also has antiseptic and local anesthetic activity.

Pharmacokinetics.

Spectrofluorometric studies have shown that benzidamine adheres to the vaginal epithelium and reaches concentrations of 9.7 ± 6.24 μg/g. Gradual absorption through the mucous membranes results in low drug levels in the blood, which are insufficient to cause systemic pharmacological effects. Elimination occurs primarily via urine as inactive metabolites or conjugated products.

Clinical characteristics.

Indications. Vulvovaginitis of various origins, characterized by slight vaginal discharge, itching, irritation, burning, and pain in the external genital organs.

Female hygiene in the postpartum period.

Contraindications.

Hypersensitivity to the active substance or to other components of the drug, salicylic acid and/or other NSAIDs.

Interaction with other medicinal products and other forms of interaction.

No reports of any interaction with other systemically administered medicinal products.

Special precautions for use.

Prolonged use of topical preparations may lead to the development of hypersensitivity reactions. In such cases, treatment should be discontinued and appropriate therapy initiated.

In case of vaginal bleeding and/or leukorrhea, the patient must consult a physician prior to using the drug.

Use during pregnancy or breastfeeding.

There are no contraindications for the topical use of benzydamine during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

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

Dosage and Administration.

1-2 vaginal irrigations daily for 7 consecutive days.

The solution can be used at room temperature. To warm it, place the closed bottle under a stream of hot water for several minutes.

The procedure should be performed in a lying position; the liquid should remain in the vagina for several minutes. For a single irrigation, use the entire contents of the 140 ml bottle.

Children. Not to be used in children.

Overdose.

There are no reports of overdose with benzidamine when used topically.

Following accidental ingestion of a large amount of benzidamine (> 300 mg), intoxication is possible. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (dizziness, hallucinations, excitement, anxiety, and irritability).

In acute overdose, only symptomatic treatment is possible. Patients should be closely monitored and receive supportive therapy and adequate hydration.

Side effects.

Rarely, especially with prolonged use of the drug, irritation and local hypersensitivity reactions such as burning sensation may occur. Occasionally, drowsiness, photosensitivity, and allergic reactions including skin rash, pruritus, and urticaria may develop.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, 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. 4 years.

Storage conditions.

Store the bottle in its original packaging in an upright position. Keep out of reach and sight of children.

Packaging. 140 ml of solution in a bottle equipped with a cannula and a closure cap. 5 bottles per cardboard box.

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

Manufacturer. Azienze Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Manufacturer's name and address.

Via Vecchio del Pino, 22 - 60131 Ancona (AN), Italy.