Product Description
Tantum Rosa is a medicinal product intended for use in adults to relieve inflammation, pain, and irritation. It contains benzydamine, which exhibits anti-inflammatory and analgesic properties, while also providing local anesthetic and antiseptic effects. The product is used in the management of inflammatory conditions in gynecology, supporting natural tissue regeneration and improving patient comfort.
Composition
The active substance is benzydamine hydrochloride.
One sachet (9.4 g) contains 500 mg benzydamine hydrochloride.
Excipients: sodium chloride, povidone, trimethylcetylammonium p-toluenesulphonate.
Dosage and Administration
This medicinal product should always be used exactly as described in the patient information leaflet or as directed by a physician, pharmacist, or nurse. In case of any doubt, medical advice should be sought.
The recommended dose is 1 to 2 sachets per day, depending on symptom severity.
Dissolve the contents of one sachet in 0.5 liters of boiled and cooled water immediately before use.
A fresh solution must be prepared before each application (e.g., morning and evening).
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Treatment of inflammatory symptoms of the external genital area (perineum and vulva) associated with vaginitis and/or cervicitis: perform vaginal irrigation using the solution prepared from one sachet 1–2 times daily, unless otherwise instructed by a physician.
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Treatment of inflammatory symptoms of the external genital area and postpartum perineal discomfort: cleanse the perineal and vulvar area using a solution prepared from one sachet 1–2 times daily.
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Pre- and postoperative prophylaxis in gynecology: the physician will determine the appropriate method of use.
Self-treatment should not continue uninterrupted for more than 7 days, unless a physician decides to extend therapy. Treatment should last at least 3 days to achieve improvement.
To ensure safe and proper vaginal irrigation, the instructions supplied with the irrigation device (available without prescription at pharmacies) should be followed.
Pharmacological Action
Tantum Rosa is well absorbed locally, achieving high concentrations in inflamed tissues. It is generally well tolerated and is used for the local treatment of inflammatory symptoms.
Indications
Tantum Rosa is indicated for the treatment of signs and symptoms (pain, burning, itching, discharge, redness, swelling) associated with:
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Vulvitis and vaginitis
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Cervicitis of various origins
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Post-chemotherapy and post-radiotherapy inflammatory symptoms
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Pre- and postoperative prophylaxis in gynecology
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Postpartum perineal discomfort
Contraindications
Do not use this medicine if the patient is allergic to the active substance or to any of the excipients.
Adverse Reactions
As with all medicines, adverse reactions may occur, although not in every patient.
Very rare (may affect fewer than 1 in 10,000 patients):
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Burning sensation of the vaginal mucosa
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Photoallergic rash
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Urticaria
Warnings and Precautions
Before starting treatment with Tantum Rosa, the patient should consult a physician, pharmacist, or nurse.
Topical medications, especially when used long-term, may cause hypersensitivity reactions. If this occurs, treatment should be discontinued and medical advice sought.
Tantum Rosa is intended for intravaginal use and for application to the mucosa of the external genital area only.
Do not ingest orally.
Interaction with Other Medicinal Products
Inform a healthcare professional of all medicines currently or recently used, as well as any medicines the patient intends to take. No interactions with other medicinal products are known.
Pregnancy and Breastfeeding
If the patient is pregnant, breastfeeding, suspects pregnancy, or plans to become pregnant, medical advice should be sought before using this product. Unless otherwise directed by a physician, it should be used according to the instructions provided in the leaflet.
Effects on Ability to Drive and Use Machines
Tantum Rosa has no effect on the ability to drive or operate machinery.
