Instructions Tantum rose granules for vaginal solution 500 mg sachet No. 10
Composition
active ingredient: benzydamine hydrochloride;
1 sachet contains 500 mg of benzydamine hydrochloride;
excipients: cetyltrimethylammonium para-toluenesulfonate, povidone, sodium chloride.
Dosage form
Granules for vaginal solution.
Main physicochemical properties: granules from white to almost white in color, homogeneous, without lumps and foreign particles.
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.
Clinical characteristics.
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, to 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
Tantum Rosa® should be used topically for vaginal irrigation. This medicine should not be taken orally.
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 this 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
Apply the drug 1 or 2 times a day for no longer than 7 days. In case of persistent symptoms, discontinue treatment and consult a doctor.
It is necessary to dissolve the contents of 1-2 sachets in 1 liter of water.
The irrigation procedure should be performed while lying down, and the liquid should remain in the vagina for several minutes.
Children
Do not use on 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, allergic reactions, including skin rashes, itching, urticaria may occur.
Expiration date
5 years.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children.
Packaging
10 sachets 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.
