Label: information for the user

Pyralvex solution

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, as you may need to refer to it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

-You should consult your doctor if your condition worsens or does not improve after 7 days.

1.What Pyralvex is and for what it is used.

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

3.How to use Pyralvex.

4.Possible adverse effects.

5.Storage of Pyralvex.

6.Contents of the package and additional information.

Pyralvex develops anti-inflammatory and antibacterial action in inflammatory conditions of the buccal-pharyngeal mucosa.

Due to its analgesic properties, the pain and sensitivity of the altered tissue caused by 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 mouth ulcers and irritations caused by dentures and maxillary orthopedic appliances.

Do not use Pyralvex

-If you are allergic (hypersensitive) to the active principles or to any of the excipients, included in section 6.

-In children under 12 years, unless a doctor's express indication.

Warnings and precautions

-Do not exceed the frequency of application described, as it may appear salicylate toxicity.

-It may stain teeth, dentures, and dental prostheses.

-Each bottle of this medicine should only be used by one person.

Other medicines and Pyralvex

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

Use of Pyralvex with food and drinks

Avoid eating, drinking, or rinsing your mouth for 15 minutes after application.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

Driving and operating machines

The influence of Pyralvex on the ability to drive or operate machines is none.

Pyralvex contains ethanol

This medicine contains 476 mg of ethanol (alcohol) in each ml (59.5% v/v).

It may cause a burning sensation in damaged mucosa.

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

The recommended dose is:

Adults and children over 12 years old:apply three or four times a day with the help of the brush, in the affected areas of the mouth (after removing the denture, 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 old: not recommended before 12 years of age.

Guidelines for correct use

Shake the bottle before use.

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

Do not rinse your mouth, nor eat or drink in the 15 minutes following the application of this medication.

Do not exceed the established application frequency.

If you use more Pyralvex than you should

If the application frequency is exceeded, salicylate toxicity may appear.

It is unlikely that a local overdose will occur.

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

If you forgot to use Pyralvex

If you forgot 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 compensate for the missed doses.

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

Very frequent adverse effects (occur in 1 in 10 patients): transient burning sensation at the site of application.

Frequent adverse effects (occur between 1 and 10 in 100 patients): temporary discoloration of teeth and prostheses or mucous membranes in the mouth (disappears when treatment is interrupted and with normal oral hygiene).

Very rare adverse effects (occur between 1 and 10 in 10,000 patients): allergic reactions.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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. The expiration date is the last day of the month indicated after “CAD” or “EXP”.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pyralvex

The active principles are: extract of anthraquinone glucosides 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 glucosides); salicylic acid 1 g.

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

Appearance of the product and contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing:

NORGINE PHARMA

29, rue Ethé-Virton

28109 Dreux Cedex (France)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Last review date of this leaflet: September 2021

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