Pyralvex Oral and Gingival Solution 10ml quickly relieves canker sores and other oral lesions.
Pyralvex in solution is for the local treatment of inflammatory lesions limited to the oral mucosa and local treatment of mouth ulcers.
The active ingredients are rhubarb (dry hydro-alcoholic sodium extract and purified root equivalent to 0.43 - 0.53% in anthraquinone derivatives) and salicylic acid.
This medicine is to be administered only to adults and children over 6 years of age due to its high alcohol content. It is a 10ml bottle.
The usual dosage of Pyralvex is to apply to the oral lesion with a brush or a cotton swab 2 to 4 applications per day, especially before bedtime. The product should not be swallowed, do not rinse your teeth or your mouth immediately after application.
Comment on the recommendations for use and dosage of Pyralvex Oral and Gingival Solution 10ml with our partner Avis checked after your purchase .
Pyralvex Mouth and Gingival Solution is formulated with:
The active substances are:
Rhubarb (Sodic hydro-alcoholic dry extract and purified from the root assaying 0.43 – 0.53% in anthraquinone derivatives) ......................... .................................................. .................................................. ........... 5.0g
Salicylic acid ................................................ .................................................. ........... 1.0g
For 100ml.
The other ingredients are: 96 percent ethanol, purified water.
What are the side effects and contraindications?
Presentation - Packaging
Oral and Gingival Solution Pyralvex comes in the form of a box containing a 10 ml bottle.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 01/09/2024
Product name
PYRALVEX, oral and gingival solution
Rhubarb - Salicylic acid
Sidebar
Please read this leaflet carefully before using this medicine as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is PYRALVEX, oral and gingival solution, and what is it used for?
2. What do I need to know before using PYRALVEX oral and gingival solution?
3. How do I use PYRALVEX oral and gingival solution?
4. What are the possible side effects?
5. How should PYRALVEX oral and gingival solution be stored?
6. Package contents and other information.
1. WHAT IS PYRALVEX, oral and gingival solution, AND WHEN IS IT USED?
Pharmacotherapeutic class: Other drugs for local oral treatment ATC code: A01AD11
This drug is indicated for the local treatment of inflammatory lesions limited to the oral mucosa and for the local treatment of mouth ulcers.
2. WHAT DO I HAVE TO KNOW BEFORE USING PYRALVEX, oral and gingival solution?
Never use PYRALVEX, oral and gingival solution:
- if you are allergic to the active substances or to any of the other components of this medicine, as listed in section 6.
- in children under 16 years of age.
- if you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea).
Warnings and precautions
Talk to your doctor or pharmacist before using PYRALVEX, oral and gingival solution.
Do not exceed the indicated dosage. Salicylate (aspirin) toxicity may occur if the recommended frequency of application is exceeded.
There is a risk of discoloration of teeth, dentures and dental prostheses.
If lesions spread and/or fever develops, CONSULT YOUR DOCTOR IMMEDIATELY.
Children
Not applicable.
Other drugs and PYRALVEX, oral and gingival solution
In view of possible drug interference (antagonism, inactivation), the simultaneous or successive use of other drugs for bucco-gingival application is not recommended.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medication.
PYRALVEX oral and gingival solution with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Before the beginning of the 6th month of pregnancy (up to the 24th week of amenorrhea), you should not take this medicine unless absolutely necessary, as determined by your doctor, due to the potential risk of miscarriage or malformations. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
From the beginning of the 6th month to the end of pregnancy (beyond the 24th week of amenorrhea), this medicine is contraindicated.Under no circumstances should you take this medicine, as its effects on your child may be serious or even fatal, particularly on the heart, lungs and/or kidneys, even with a single dose.
If you have taken this medicine while pregnant, tell your obstetrician-gynecologist immediately, so that appropriate monitoring can be offered if necessary.
Breast-feeding
As this drug passes into breast milk, it is not recommended to use it while breast-feeding.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women and cause difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
If you discover that you are pregnant, consult your doctor, who is the only person who can judge whether you should continue treatment.
Driving and use of machinery
Not applicable.
PYRALVEX oral and gingival solution contains ethanol (alcohol).
This drug contains 476 mg alcohol (ethanol) per mL solution equivalent to 59.5% v/v. This may cause a burning sensation on damaged skin.
3. HOW TO USE PYRALVEX, oral and gingival solution?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
FOR INDIVIDUALS ONLY (including the elderly).
Dosage
The recommended dose is 2 to 4 applications per day, especially before bedtime.
Method of administration
Local use.
Do not swallow.
Apply to the lesion with a brush (integrated into the cap) or cotton bud.
Do not rinse teeth or mouth immediately after application.
Do not eat or drink immediately after use.
Treatment time
Treatment should not exceed 5 days without medical advice. If there is no improvement, consult a doctor.
If you have taken more PYRALVEX, oral and gingival solution than you should have
An overdose is unlikely under normal conditions of use (2 to 4 local applications per day). An overdose may occur if the recommended frequency of application is exceeded and/or if the product is swallowed. In this case, contact your doctor.
If you forget to take PYRALVEX, oral and gingival solution
Not applicable.
If you stop taking PYRALVEX, oral and gingival solution
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Allergic reactions, including rash and itching.
- A slight tingling sensation may be experienced due to the presence of alcohol.
- Yellow discoloration of teeth or oral mucosa, reversible on discontinuation of treatment.
Declaration of side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE PYRALVEX, oral and gingival solution?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What PYRALVEX oral and gingival solution contains
- The active ingredients are :
Rhubarb (Purified hydroalcoholic sodium extract of root with 0.43-0.53% anthraquinone derivatives) ........................................................................................................................................ 5.0 g
Salicylic acid ............................................................................................................. 1.0 g
Per 100 mL.
- Other components are : 96% ethanol (alcohol), purified water.
What PYRALVEX oral and gingival solution is and what it contains
PYRALVEX is an oral and gingival solution.
10 mL, 25 mL or 50 mL glass bottle with integrated brush (nylon/PP) and PE cap.
Not all presentations may be marketed.
Marketing authorization holder
MEDA PHARMA
1 BIS PLACE DE LA DEFENSE TOUR TRINITY
92400 COURBEVOIE
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
NORGINE PHARMA
29 RUE ETHE VIRTON
28100 DREUX
Drug names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
[to be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
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