Pyralvex solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Pyralvex solution
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or do not improve after 7 days.
Leaflet contents:
- What Pyralvex is and what it is used for.
- What you need to know before using Pyralvex.
- How to use Pyralvex.
- Possible side effects.
- How to store Pyralvex.
- Contents of the pack and other information.
1. What Pyralvex is and what it is used for
Pyralvex exerts an anti-inflammatory and antibacterial action in inflammatory conditions of the oropharyngeal mucosa.
Due to its analgesic properties, pain and sensitivity of tissue affected by inflammation are rapidly relieved. The mucous membranes can soon resume their physiological functions. Pyralvex is not aggressive to mucous membranes and its method of use is simple and painless.
Pyralvex is indicated for:
Relief of pain in mild inflammatory conditions of the oral mucosa, such as aphthae and irritations caused by dentures and maxillary orthopedic appliances.
2. What you need to know before starting to use Pyralvex
Do not use Pyralvex
- If you are allergic (hypersensitive) to the active substances or to any of the excipients listed in section 6.
- In children under 12 years of age, unless expressly indicated by a doctor.
Warnings and precautions
- Do not exceed the recommended frequency of application, as salicylate toxicity may occur.
- It may stain teeth, dentures, and dental prostheses.
- Each bottle of this medicine should be used by only one person.
Other medicines and Pyralvex
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained 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 to your doctor before using Pyralvex. Pyralvex may be used during the first and second trimesters of pregnancy after careful benefit-risk assessment. If the medicine 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 duration of treatment should be as short as possible.
The use of Pyralvex should be avoided during the third trimester of pregnancy.
Driving and use of machines
Pyralvex has no influence on the ability to drive or operate machinery.
Pyralvex contains ethanol
This medicine contains 476 mg of ethanol (alcohol) per ml (59.5% v/v).
It may cause a burning sensation on damaged mucosa.
3. How to use Pyralvex
Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years of age: apply three or four times a day using the brush provided, to the affected areas in the mouth (after removing dentures, if applicable).
Seek medical advice if the condition does not improve. If symptoms persist after 7 days, consult your doctor.
Use in children under 12 years of age: not recommended in children under 12 years of age.
Instructions for correct use
Shake the bottle before use.
Apply to the affected area using the brush, then clean the brush with water. Close the bottle tightly after use.
Do not rinse your mouth, eat, or drink within 15 minutes after applying this medicine.
Do not exceed the recommended frequency of application.
If you use more Pyralvex than you should
If the frequency of application is exceeded, salicylate toxicity may occur.
Overdose is unlikely to result from local application.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Pyralvex
If you forget to use Pyralvex, apply it as soon as you remember, unless it is nearly time for the next dose; in that case, continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, Pyralvex may produce adverse effects, although not everyone experiences them.
Very common adverse effects (occur in 1 out of every 10 patients): transient local burning sensation at the application site.
Common adverse effects (occur in 1 to 10 out of every 100 patients): temporary discoloration of teeth and dental prostheses or of the oral mucosa (disappears when treatment is discontinued and with normal oral hygiene).
Very rare adverse effects (occur in 1 to 10 out of every 10,000 patients): allergic reactions.
Adverse effects with unknown frequency (cannot be estimated from available data): exanthema (skin rash) and urticaria (skin swelling and redness).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pyralvex
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry 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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Package contents and other information
Composition of Pyralvex
The active substances are: anthraquinone glycoside extract from Rheum officinale (rhubarb) and salicylic acid.
100 ml of solution contains 5 g of Rheum officinale (rhubarb) extract (equivalent to 0.5 g of anthraquinone glycosides); 1 g of salicylic acid.
The other components are ethanol 59.5% (v/v) and water.
Appearance of the product and contents of the container
Amber glass bottle with an applicator brush containing 5 ml or 10 ml of solution.
Only certain package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer:
NORGINE PHARMA
29, rue Ethé-Virton
28109 Dreux Cedex (France)
Further information on this medicinal product is available upon request 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 most recent revision of this leaflet: September 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/