Tantum Rosa

Leaflet attached to the packaging: patient information

TANTUM ROSA

Benzydamine hydrochloride
53.2 mg/g, powder for solution for intravaginal use

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Tantum Rosa and what is it used for
• 2. Important information before using Tantum Rosa
• 3. How to use Tantum Rosa
• 4. Possible side effects
• 5. How to store Tantum Rosa
• 6. Contents of the packaging and other information

1. What is Tantum Rosa and what is it used for

Tantum Rosa contains the active substance benzydamine, which belongs to non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has anti-inflammatory, analgesic, and local anesthetic and antiseptic effects. The medicine is well absorbed locally, achieving high concentrations in inflamed tissues. The medicine is generally well tolerated. It is used for the local treatment of inflammation symptoms.
Tantum Rosa is used intravaginally and on the mucous membrane of the external genital organs.
The medicine is used to treat discomfort and symptoms such as pain, burning, itching, redness, discharge, swelling in the area of the external genital organs and vagina.
These discomfort and symptoms occur as a result of vulvitis and vaginitis, cervicitis of various origins (e.g. infection, mechanical irritation), also after chemotherapy and radiotherapy. The medicine is also used in pre- and post-operative prophylaxis in gynecology, as well as to alleviate vulvar discomfort during the postpartum period.

2. Important information before using Tantum Rosa

When not to use Tantum Rosa

If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Tantum Rosa, consult a doctor, pharmacist, or nurse.
Using, especially long-term, medicines with local action may cause an allergic reaction. In such a case, Tantum Rosa should be discontinued and a doctor consulted, who will recommend appropriate action.
Tantum Rosa is intended for intravaginal use and on the mucous membrane of the external genital organs. It should not be taken orally.

Tantum Rosa and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions of Tantum Rosa with other medicines are known.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Unless your doctor advises otherwise, use the medicine according to the instructions in the leaflet.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

3. How to use Tantum Rosa

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
In case of doubts, consult a doctor, pharmacist, or nurse.
The recommended dose is from 1 to 2 sachets per day, depending on the severity of the symptoms.
The contents of one sachet should be dissolved in 0.5 liters of boiled and cooled water, immediately before use.
A new solution should be prepared from one sachet each time (e.g. in the morning and evening).
Treatment of symptoms and signs of inflammation of the external genital organs (perineal and vulvar area) coexisting with vaginitis and/or cervicitis: rinse the vagina with the solution obtained from one sachet 1 to 2 times a day, unless otherwise directed by a doctor.
Treatment of symptoms and signs of inflammation of the external genital organs (perineal and vulvar area) and postpartum discomfort in the perineal area: rinse the perineal and vulvar area with the solution obtained from one sachet 1 to 2 times a day.
Pre- and post-operative prophylaxis in gynecology: the doctor will decide on the proper use of the medicine.
In case of self-initiated treatment, the medicine should not be used continuously for more than 7 days, and any extension should be decided by a doctor.
To achieve improvement, treatment should not last less than 3 days.
To properly and safely perform vaginal rinsing (irrigation), read the instructions for use attached to the vaginal irrigator, available at pharmacies without a prescription.

Using more than the recommended dose of Tantum Rosa

Overdose of the medicine is unlikely due to the low concentration of the active substance in the medicine and the local route of administration. No cases of overdose have been observed so far.
In case of accidental ingestion of the medicine, contact a doctor or pharmacist immediately.
In case of any further doubts related to the use of the medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (occurring in less than 1 in 10,000 people):
burning sensation of the vaginal mucosa, photoallergic rash, urticaria.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tantum Rosa

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tantum Rosa contains

The active substance of the medicine is benzydamine hydrochloride.
1 sachet (9.4 g) contains 500 mg of benzydamine hydrochloride.
The other excipients are sodium chloride, povidone, p-toluenesulfonic acid trimethyloctylammonium.

What Tantum Rosa looks like and contents of the packaging

Tantum Rosa is a powder that should be dissolved in water to prepare a solution.
The immediate packaging of the medicine is a paper-polypropylene sachet containing 9.4 g of powder. The outer packaging, a cardboard box, contains 6 or 10 sachets.

Marketing authorization holder

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia 70, 00181 Rome, Italy

Manufacturer

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona, Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate BG, Italy

Representative of the marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
The patient leaflet in a format suitable for the blind and partially sighted is available at the representative's office of the marketing authorization holder.

Date of the last update of the leaflet: