Tantum Rosa vaginal solution 0.1% bottle 140 ml + cannula No. 5

Instructions for use Tantum Rosa vaginal solution 0.1% bottle 140 ml + cannula No. 5

Composition

active ingredient: benzydamine hydrochloride;

100 ml of solution contains 100 mg of benzydamine hydrochloride;

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

Dosage form

Vaginal solution.

Main physicochemical properties: colorless transparent liquid with a typical rose odor.

Pharmacotherapeutic group

Anti-inflammatory drugs for vaginal administration.

ATX code G02C C03.

Pharmacological properties

Pharmacodynamics

Benzydamine is a nonsteroidal anti-inflammatory drug with analgesic and anti-edematous properties. When applied topically, it also has antiseptic and local anesthetic activity.

Pharmacokinetics

Using spectrofluorometry, benzydamine has been shown to adhere to the vaginal epithelium and reach concentrations of 9.7 ± 6.24 μg/g. Gradual absorption through the mucous membranes results in low blood levels of the drug that are insufficient to cause systemic pharmacological effects. Excretion occurs mainly in the urine in the form of inactive metabolites or conjugated products.

Indication

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

Feminine hygiene in the postpartum period.

Contraindication

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 types of interactions

There are no reports of any interactions with other commonly used medicines.

Application features

Prolonged use of topical preparations may lead to the development of hypersensitivity phenomena. In this case, treatment should be discontinued and appropriate therapy should be initiated.

In case of vaginal bleeding and/or leukorrhea, the patient should consult a doctor before using the drug.

Use during pregnancy or breastfeeding

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

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug has no effect on the ability to drive vehicles and operate machinery.

Method of administration and doses

1-2 vaginal irrigations daily for 7 consecutive days.

The solution can be used at room temperature. To warm, place the closed bottle under running hot water for a few minutes.

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

Children. Do not use in children.

Overdose.

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

Adverse reactions

Rarely, especially with prolonged use of the drug, irritation, local hypersensitivity in the form of burning may occur. Sometimes drowsiness, photosensitivity, allergic reactions, including skin rashes, itching, urticaria may occur.

Expiration date

4 years.

Storage conditions

Store in original packaging. Keep out of reach of children.

Packaging

140 ml of solution in a bottle equipped with a cannula with a cap for closing. 5 bottles in a cardboard box.

Vacation category

Without a prescription.

Producer

Aziende Kimike Riunite Angelini Francesco A.K.R.A.F. S.p.A., Italy.

Location of the manufacturer and its business address

Via Vecchio Del Pinocchio, 22 – 60100 Ancona (AN), Italy.