It belongs to a group of medicines called vaginal administration anti-inflammatory drugs.
This medicine is indicated for local and temporary relief of itching and stinging of the external vaginal area in adults.
1. What Rosalgin is and what it is used for
It belongs to a group of medicines called anti-inflammatories 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 use Rosalgin
Do not use Rosalgin
- If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
- Talk to your pharmacist before using Rosalgin.
- This medicine is for vaginal use only .
- Once the solution has been applied, it is recommended to wash your hands with plenty of water, since cases of photosensitive allergic reactions have been reported after exposing the hands to sunlight, without previously removing the product (see section “4. Possible effects adverse ”).
- In the case of sensitivity or irritation, or persistent burning or itching, you should stop treatment and consult your doctor (see section 4 " Possible side effects ").
- If the symptoms worsen or remain after 5 days or you notice increased vaginal discharge or changes in its appearance or smell or bleeding, you should consult your doctor.
Interaction of Rosalgin with other drugs
Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.
There are no known interactions with other medications.
Rosalgin with food, drink and alcohol
Not applicable because it is a drug for vaginal use.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The use of this medicine does not affect the ability to drive or use machines, since systemic absorption is practically nil or negligible.
3. How to use Rosalgin
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
THIS MEDICINE IS FOR VAGINAL USE ONLY.
The recommended dose is 1 or 2 external washes a day for 5 days.
The preparation of the solution is done by dissolving the content of 2 sachets in 1 liter of water. The water may be warm.
Once the solution is applied, wash your hands with plenty of water.
If you use more Rosalgin than you should
No cases of overdose have been observed with Rosalgin used vaginally.
In case of accidental oral ingestion of benzydamine hydrochloride, you may not have symptoms or you may feel nausea, vomiting, abdominal pain, dizziness, visual hallucinations or irritability, muscle weakness, tremor, drowsiness, headache, blurred vision, high blood pressure, among others. . There is no specific antidote, however, it usually remits spontaneously once the drug is eliminated. Symptomatic treatment may be necessary.
If you accidentally swallow any of your medicine, immediately contact your doctor or pharmacist for advice. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Rosalgin
Do not take a double dose to make up for a forgotten dose.
If you stop taking Rosalgin
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Rosalgin can cause side effects, although not everyone gets them.
Very rare side effects (less than 1 in 10,000 people):
- Sensitivity of the skin to sunlight (causing a rash or sunburn), burning, itching in the area of application.
If you experience side effects, consult your doctor or pharmacist, even if they are side effects that are not listed in this leaflet.
5. How to store Rosalgin
It does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP . The expiration date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. Package contents and additional information
Composition of Rosalgin
- The active substance is benzydamine (as benzydamine hydrochloride). Each sachet contains 500 mg of benzydamine hydrochloride.
- The other ingredients (excipients) are: tricetol, sodium chloride and povidone K-25.
What the product looks like and contents of the pack
Rosalgin is available as a white vaginal solution granules. Each box contains 10, 20 or 200 sachets.
Marketing authorization holder
ANGELINI PHARMA ESPAÑA, SL
C. Osi, 7 - 08034 Barcelona
Responsible for manufacturing
ACRAF SpA
Via Vecchia del Pinocchio, 22
60131 Ancona (Italy)
or
FINE FOODS & PHARMACEUTICALS NTM, SPA
Via Grignano 43
24041 BREMBATE (BG) - Italy
The last revision of this leaflet was in July 2016
Detailed and updated information on this drug is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/