ROSALGIN 500 mg GRANULES FOR VAGINAL SOLUTION

Introduction

Package Leaflet: Information for the User

Rosalgin 500 mg Granules for Vaginal Solution

Bencidamine Hydrochloride

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

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Contents of the Package Leaflet

1. What is Rosalgin and what is it used for
2. What you need to know before you start using Rosalgin
3. How to use Rosalgin
4. Possible side effects
5. Storage of Rosalgin
6. Package Contents and Additional Information

1. What is Rosalgin and what is it 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 of the external vaginal area in adults.

2. What you need to know before you start using Rosalgin

Do not use Rosalgin

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

Warnings and Precautions

• Consult your pharmacist before starting to use Rosalgin.
• This medicine is for vaginal use only.
• Once the solution is applied, it is recommended to wash your hands with plenty of water, as cases of photosensitive allergic reactions have been described after exposure of the hands to sunlight without previously removing the product (see section 4 “Possible Side Effects”).
• In case of sensitivity or irritation, or persistent burning or itching, you should discontinue treatment and consult your doctor (see section 4 “Possible Side Effects”).
• If your symptoms worsen or persist after 5 days, or if you notice an increase in vaginal discharge or changes in its appearance or odor, or bleeding, you should consult your doctor.

Interaction of Rosalgin with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

No interactions with other medicines are known.

Rosalgin with Food, Drink, and Alcohol

This is not applicable since it is a medicine for vaginal use.

Pregnancy, Breastfeeding, and Fertility

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

You should not use Rosalgin during pregnancy unless it is clearly necessary and your doctor advises you to do so. If you need treatment, you should use the lowest dose for the shortest possible time.

Driving and Using Machines

Using this medicine does not affect your ability to drive or use machines since systemic absorption is practically zero or insignificant.

3. How to Use Rosalgin

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

THIS MEDICINE IS FOR VAGINAL USE ONLY.

The recommended dose is 1 or 2 external washes per day for 5 days.

The preparation of the solution is done by dissolving the contents of 2 sachets in 1 liter of water. The water can be lukewarm.

Once the solution is applied, wash your hands with plenty of water.

If You Use More Rosalgin Than You Should

No cases of overdose with Rosalgin used vaginally have been observed.

In case of accidental oral ingestion of bencidamine hydrochloride, you may not have symptoms or you may feel nausea, vomiting, abdominal pain, dizziness, visual hallucinations, or irritability, muscle weakness, tremors, somnolence, headache, blurred vision, hypertension, among others. There is no specific antidote; however, it usually resolves spontaneously once the drug is eliminated. Symptomatic treatment may be necessary.

If you accidentally ingest some of your medicine, contact your doctor or pharmacist immediately for advice. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget to Use Rosalgin

Do not apply a double dose to make up for forgotten doses.

If You Stop Using Rosalgin

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

4. Possible Side Effects

Like all medicines, Rosalgin can cause side effects, although not everybody gets them.

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

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

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

5. Storage of Rosalgin

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 CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosalgin

• The active ingredient is bencidamine (as bencidamine hydrochloride). Each sachet contains 500 mg of bencidamine hydrochloride.
• The other ingredients (excipients) are: tricetol, sodium chloride, and povidone K-25.

Appearance of the Product and Package Contents

Rosalgin is presented as a white granulate for vaginal solution. Each box contains 10, 20, or 200 sachets.

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)

or

FINE FOODS & PHARMACEUTICALS N.T.M., S.P.A.

Via Grignano 43

24041 BREMBATE (BG) - Italy

This package leaflet was last revised inJuly 2025

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