PYRALVEX SOLUTION

Introduction

Package Leaflet: Information for the User

Pyralvex Solution

Read this entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as 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 they are side effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What Pyralvex is and what it is used for.
2. What you need to know before starting to use Pyralvex.
3. How to use Pyralvex.
4. Possible side effects.
5. Storage of Pyralvex.
6. Package contents and additional information.

1. What Pyralvex is and what it is used for

Pyralvex has anti-inflammatory and antibacterial effects on inflammatory conditions of the buccopharyngeal mucosa.

Due to its analgesic properties, pain and sensitivity of the altered tissue due to inflammation are quickly suppressed. The mucous membranes can soon resume their physiological functions. Pyralvex is not aggressive to the mucous membranes, and its mode of use is simple and painless.

Pyralvex is indicated for:

Relief of pain in mild inflammatory conditions of the mouth mucosa, such as aphthae and irritations caused by dentures and orthopedic maxillary appliances.

2. What you need to know before starting to use Pyralvex

Do not use Pyralvex

• If you are allergic (hypersensitive) to the active ingredients or to any of the excipients listed in section 6.
• In children under 12 years of age, unless explicitly indicated by a doctor.

Warnings and Precautions

• Do not exceed the recommended application frequency, as salicylate toxicity may occur.
• It may stain teeth, dentures, and dental prostheses.
• Each bottle of this medication should only be used by one person.

Other Medications and Pyralvex

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Using Pyralvex with Food and Beverages

Avoid eating, drinking, or rinsing your mouth during the 15 minutes following application.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, talk to your doctor before using Pyralvex. Pyralvex may be used during the first and second trimester of pregnancy after carefully weighing the benefit-risk. If the medication is used by a woman who is trying to conceive or during the first or second trimester of pregnancy, the dose should be kept as low as possible, and the treatment duration should be as short as possible.

The use of Pyralvex should be avoided during the third trimester of pregnancy.

Driving and Using Machines

The influence of Pyralvex on the ability to drive or use machines is nil.

Pyralvex contains ethanol

This medication contains 476 mg of ethanol (alcohol) per ml (59.5% v/v).

It may cause a burning sensation on the damaged mucosa.

3. How to use Pyralvex

Follow these instructions for the medication contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years:apply three or four times a day with the help of the brush, to the affected areas of the mouth (after removing dentures, if applicable).

Seek medical attention if the condition does not improve. If symptoms persist after 7 days, consult your doctor.

Use in children under 12 years:not recommended before the age of 12.

Guidelines for correct use

Shake the bottle before use.

Apply to the affected area using the brush, and then clean the brush with water. Close the bottle tightly after use.

Do not rinse your mouth, eat, or drink in the 15 minutes following application of this medication.

Do not exceed the recommended application frequency.

If you use more Pyralvex than you should

If you exceed the application frequency, salicylate toxicity may occur.

It is unlikely that an overdose associated with local application will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Pyralvex

If you forget to use Pyralvex, use it as soon as you remember, unless the next dose is near, and then follow the normal schedule. Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Pyralvex can cause side effects, although not everyone will experience them.

Very common side effects (occurring in 1 in 10 patients): transient local burning sensation at the application site.

Common side effects (occurring in 1 to 10 out of 100 patients): temporary staining of teeth and prostheses or oral mucosa (disappears when treatment is interrupted and with normal mouth cleaning).

Very rare side effects (occurring in 1 to 10 out of 10,000 patients): allergic reactions.

In cases with unknown frequency (cannot be estimated from available data): exanthema (skin rash) and urticaria (skin inflammation and redness).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pyralvex

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated after "CAD" or "EXP".

Keep the bottle tightly closed, protected from light, and below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Pyralvex

The active ingredients are: extract of anthraquinone glycosides from Rheum officinale (rhubarb) and salicylic acid.

100 ml of solution contains extract of Rheum officinale (rhubarb) 5 g (equivalent to 0.5 g of anthraquinone glycosides); salicylic acid 1 g.

The other components are ethanol 59.5% (v/v) and water.

Appearance of the product and package contents

Ambber glass bottle with applicator brush containing 5 ml or 10 ml of solution.

Only some package sizes may be marketed.

Marketing Authorization Holder and manufacturer

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer:

NORGINE PHARMA

29, rue Ethé-Virton

28109 Dreux Cedex (France)

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Date of the last revision of this leaflet:September 2021

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