Leaflet: information for the user

Rosalgin 500 mg vaginal granule solution

Benzydamine hydrochloride

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

Follow exactly the administration instructions for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if you get worse or do not improve after 5 days.

1. What isRosalginand what it is used for

2. What you need to know before starting to useRosalgin

3. How to useRosalgin

4. Possible side effects

5. Storage ofRosalgin

6. Contents of the pack and additional information

It belongs to a group of medications called vaginal anti-inflammatory agents.

This medication is indicated for the local and temporary relief of itching and burning sensation in the external vaginal area in adults.

Do not use Rosalgin

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

Warnings and precautions

• Consult your pharmacist before starting to use Rosalgin.
• This medication is used only vaginally.
• After applying the solution, it is recommended to wash your hands thoroughly with plenty of water, as cases of photosensitive allergic reactions have been described after exposure of the hands to sunlight without first removing the product (see section “4. Possible side effects”).
• In the case of sensitivity or irritation, or persistent burning or itching, you must suspend treatment and consult with your doctor (see section 4 “Possible side effects”).
• If 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 must consult your doctor.

Rosalgin interactions with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions with other medications are known.

Rosalgin with food, drink, and alcohol

This is not applicable as it is a vaginal medication.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

The use of this medication does not affect your ability to drive or operate machines, as systemic absorption is practically zero or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

THIS MEDICATION IS USED ONLY BY VAGINAL ROUTE.

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

The solution preparation is carried out by dissolving the contents of 2 sachets in 1 liter of water. The water can 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 by vaginal route.

In case of accidental oral ingestion of bencidamine hydrochloride, you may not have symptoms or may feel nausea, vomiting, abdominal pain, dizziness, visual hallucinations or irritability, muscle weakness, tremors, drowsiness, 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 medication, contact your doctor or pharmacist immediately for advice. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Rosalgin

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Rosalgin

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

Like all medications, Rosalgin may cause adverse effects, although not all people will experience them.

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

-Sunlight sensitivity (causing rash or sunburn), burning, itching at the application site.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

No special conservation conditions are required.

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

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Rosalgin

-The active ingredient is bencidamine (as hydrochloride of bencidamine). Each sachet contains 500 mg of hydrochloride of bencidamine.

-The other components (excipients) are: tricetol, sodium chloride and povidone K-25.

Appearance of the product and contents of the packaging

Rosalgin is presented in the form of a vaginal solution granule, white in color. Each box contains 10, 20 or 200 sachets.

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

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

Last review of this leaflet was inJuly 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/