Rosalgin 500 mg granules for vaginal solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Rosalgin 500 mg granules for vaginal solution
Bendiguanil hydrochloride
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.
- You should consult a doctor if your condition worsens or if you do not improve after 5 days.
Leaflet Contents
- What Rosalgin is and what it is used for
- What you need to know before using Rosalgin
- How to use Rosalgin
- Possible side effects
- How to store Rosalgin
- Contents of the pack and other information
1. What Rosalgin 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 in the external vaginal area in adults.
2. What you need to know before using Rosalgin
Do not use Rosalgin
- If you are allergic to benzydamine or to any of the other ingredients 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.
- 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 without prior removal of the product (see section “4. Possible adverse effects”).
- If you experience sensitivity, irritation, or persistent burning or itching, discontinue treatment and consult your doctor (see section 4 “Possible adverse effects”).
- If symptoms worsen or persist beyond 5 days, or if you notice an increase in vaginal discharge, changes in its appearance or odor, or bleeding, you should consult your doctor.
Interaction of Rosalgin with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions with other medicines are known.
Rosalgin with food, drink and alcohol
Not applicable, as this is a medicine intended for vaginal use.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You should not use Rosalgin during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest possible dose should be used for the shortest possible duration.
Driving and using machines
The use of this medicine does not affect the ability to drive or operate machinery, as systemic absorption is practically negligible or insignificant.
3. How to use Rosalgin
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
THIS MEDICINE IS FOR EXTERNAL VAGINAL USE ONLY.
The recommended dose is 1 or 2 external washes per day for 5 days.
To prepare the solution, dissolve the contents of 2 sachets in 1 litre of water. The water may be lukewarm.
After applying the solution, wash your hands thoroughly with plenty of water.
If you use more Rosalgin than you should
No cases of overdose have been reported with Rosalgin when used vaginally.
In case of accidental oral ingestion of bencidamine hydrochloride, you may experience no symptoms or may have 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 your medicine, 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
Do not use a double dose to make up for forgotten doses.
If you stop using Rosalgin
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 may cause adverse effects, although not everyone gets them.
Very rare adverse effects (less than 1 in 10,000 people):
- Skin sensitivity to sunlight (causing rash or sunburn), burning sensation, itching at the site of application.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Rosalgin Storage
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 container 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 containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rosalgin
- The active substance is benzydamine (as benzydamine hydrochloride). Each sachet contains 500 mg of benzydamine hydrochloride.
- The other components (excipients) are: tricetol, sodium chloride and povidone K-25.
Nature of the product and pack contents
Rosalgin is presented as a white granular powder 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
The latest revision of this leaflet was in July 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/