Rosalgin Pronto 140 mg vaginal solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosalgin pronto 140 mg vaginal solution

bendigal hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Contents of the leaflet

1. What Rosalgin pronto is and what it is used for
2. What you need to know before using Rosalgin pronto
3. How to use Rosalgin pronto
4. Possible adverse effects
5. How to store Rosalgin pronto
6. Contents of the pack and other information

1. What Rosalgin Pronto is and what it is used for

It belongs to a group of medicines called anti-inflammatory agents for vaginal administration.

This medicine is indicated for the local and temporary relief of itching and burning, as an adjunct to the treatment of vaginitis in adults.

You should consult a doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before using Rosalgin pronto

Do not use Rosalgin pronto

• If you are allergic to bencidamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Rosalgin pronto.

• This medicine is for vaginal use only.
• After applying the solution, it is recommended to wash your hands thoroughly with plenty of water, as cases of photosensitive allergic reactions have been reported following exposure of the hands to sunlight, when the product has not been previously removed (see section 4).
• If you experience sensitivity, irritation, persistent burning, or itching, you must stop treatment and consult your doctor (see section 4).
• If you notice increased vaginal discharge or changes in its appearance or odor, or bleeding, you should consult your doctor.

Other medicines and Rosalgin pronto

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions with other medicines are known.

Use of Rosalgin pronto with food, drinks and alcohol

Not applicable, as this is a medicine for vaginal use.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Rosalgin pronto during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest dose for the shortest possible duration should be used.

Driving and using machines

The use of this medicine does not affect the ability to drive or operate machinery, as absorption is practically negligible or insignificant.

Rosalgin pronto contains benzalkonium chloride, ethanol and fragrances containing allergens

This medicine contains 28 mg of benzalkonium chloride per bottle (140 ml). Benzalkonium chloride may cause local irritation.

This medicine contains 107.8 mg of ethanol per bottle (140 ml). It may cause a burning sensation on damaged skin.

This medicine contains fragrances with benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool and d-limonene.

Benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool and d-limonene may cause allergic reactions.

3. How to use Rosalgin pronto

Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

THIS MEDICINE IS FOR VAGINAL USE ONLY.

The recommended dose is 1 or 2 vaginal irrigations per day for 5 days.

After applying the solution, wash your hands thoroughly with plenty of water.

If you are using other vaginal medications, Rosalgin pronto should be administered first to avoid removing the other medication.

The solution can be used at room temperature or by placing the closed bottle in lukewarm water for a few minutes.

To use the single-dose applicator, follow these steps:

1. To open the bottle, hold the upper ring firmly as shown in the figure, and twist the cap until the seal breaks.

2. Pull out the cannula until you feel it stop at the top. Only fully extracting the cannula will allow the liquid to flow out.

3. Gently insert the cannula into the vagina and squeeze the bottle until it is completely emptied.

Emptying may occur gradually. An integrated valve prevents reflux of the solution back into the bottle.

To achieve full therapeutic effect, the liquid should remain in the vagina for a few minutes.

If you use more Rosalgin pronto than you should

No cases of overdose have been reported with vaginal use of Rosalgin pronto.

In case of accidental oral ingestion of bencidamine hydrochloride, you may experience no symptoms or may develop nausea, vomiting, abdominal pain, dizziness, visual hallucinations, irritability, muscle weakness, tremor, drowsiness, headache, blurred vision, or high blood pressure, among others. There is no specific antidote; however, symptoms usually resolve spontaneously once the drug is eliminated. Symptomatic treatment may be necessary.

If you accidentally ingest any of this medication, contact your doctor or pharmacist immediately for advice. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Rosalgin pronto

Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rosalgin pronto may produce adverse effects, although not everyone experiences them.

Very rare adverse effects (affects less than 1 in 10,000 people):

• Skin sensitivity to sunlight (causing rash or sunburn), burning, itching at the application site.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosalgin pronto

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Rosalgin pronto

• The active substance is benzidamine (as benzidamine hydrochloride). Each bottle contains 140 mg of benzidamine hydrochloride.
• The other components (excipients) are: benzalkonium chloride, disodium edetate, ethanol, polysorbate 20, rose oil (containing: benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool and d-limonene) and purified water.

Appearance of the product and contents of the container

Rosalgin pronto is presented as a vaginal solution. The solution is colourless and clear, and is contained in polyethylene bottles with 140 ml of solution.

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona (Italy)

Date of the most recent revision of this leaflet: July 2025.

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/