Leaflet: information for the user

Rosalgin pronto 140 mg vaginal solution

bendazol hydrochloride

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

Follow exactly the administration instructions 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. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

1. What isRosalgin prontoand what it is used for

2. What you need to know before starting to useRosalgin pronto

3. How to useRosalgin pronto

4. Possible side effects

5. Storage ofRosalgin pronto

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 local and temporary relief of itching and burning, in addition to the treatment of vaginitis, in adults.

Consult a doctor if it worsens or does not improve after 5 days.

Do not use Rosalgin pronto

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rosalgin pronto.

• This medicationis only used 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 previously removing the product (see section 4).
• In the case of sensitivity or irritation, or persistent burning or itching, you should suspend treatment and consult with your doctor (see section 4).
• If you observe an increase in vaginal discharge or changes in its appearance, odor, or bleeding, you should consult your doctor.

Other medications andRosalgin pronto

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

No interactions with other medications are known.

Use of Rosalgin pronto with food, drinks, and alcohol

This is not applicable as it is a vaginal medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 absorption is practically negligible or insignificant.

Rosalgin pronto contains benzalkonium chloride, ethanol, and fragrances containing allergens

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

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

This medication contains fragrances containing benzyl alcohol, benzyl benzoate, cinnamyl benzoate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool, and d-limonene.

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

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

THIS MEDICINE IS USED ONLY BY VAGINAL ROUTE.

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

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

In case you use other vaginal medications, Rosalgin pronto should be administered first, in order to avoid the elimination of the other medication.

Rosalgin pronto can be used at room temperature or by introducing the closed bottle for a few minutes in warm water.

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

1st To open the bottle, keep the upper ring fixed, as shown in the figure, and turn the cap until the seal is broken.

2nd Extract the cannula until you feel the impact with the top. Only the complete extraction of the cannula will allow the liquid to come out.

3rd Gently introduce the cannula into the vagina and compress the bottle until it is empty.

The emptying can be gradual. A valve incorporated prevents the solution from flowing back into the bottle.

To achieve full therapeutic activity, the liquid must be kept in the vagina for a few minutes.

If you use more Rosalgin pronto than you should

No cases of overdose have been observed with Rosalgin pronto used by vaginal route.

In case of accidental oral ingestion of benzydamine 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, high blood pressure, 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 name of the medication and the amount ingested.

If you forget to use Rosalgin pronto

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

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

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

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

-Sensitivity of the skin to sunlight (causing rash or sunburn),burning, itching at the application site.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conditions for conservation.

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 after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash.Deposit the packaging and the medication that you no longer need in the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Rosalgin pronto

• The active ingredient isbencidamina (as hydrochloride of bencidamina). Each bottle contains 140 mg of hydrochloride of bencidamina.
• The other components (excipients) are: benzalkonium chloride, disodium edetate, ethanol, polisorbate 20, rose oil (contains: alcohol bencílico, benzoate of bencilo, cinnamate of bencilo, salicylate of bencilo, citral, citronellol, eugenol, farnesol, geraniol, linalol and d-limonene) and purified water.

Appearance of the product and contents of the packaging

Rosalgin pronto is presented in the form of a vaginal solution. The solution is transparent and colorless and is packaged in polyethylene bottles with 140 ml of solution.

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)

Date of the last review of this prospectus:July 2016.

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