PYRALVEX®

Each ml of solution contains 0.05g of rhubarb (corresponding to 0.003g of anthrachinonic glucosides); 0.01g of salicylic acid and hydro-alcoholic excipient q.s. 1 ml.
Vials with 10 or 30 ml of solution.

PHARMACOTHERAPEUTIC CLASS
VII -1 - Medicines for topical application in the mouth

MARKETING AUTHORIZATION HOLDER
NORGINE PHARMA,
87, avenue de la Grande Armée
75782 PARIS Cedex 16, France

Distributed in Portugal by:
Angelini Farmacêutica, Lda
Rua João Chagas N° 53, Piso 3
1499-040 Cruz Quebrada-Dafundo

WHAT IS PYRALVEX?
PYRALVEX exerts an anti-inflammatory action in the cases of inflammatory infections on the mucosas of the mouth or throat. Its analgesic properties allow to rapidly suppress pains and the sensitivity of the tissue submitted to inflammatory processes. PYRALVEX allows that, after a short time, mucosas resume their normal physiological functions, without exerting any harmful action on the tissues. Its use is easy and painless. It is well tolerated by individuals sensitive to iodine.

IN WHICH SITUATIONS IS PYRALVEX INDICATED?
PYRALVEX is indicated in the treatment of acute and chronic inflammations of the mucosas of the mouth and throat (gingivites, periodontitis, pyorrhea).

WHEN IT SHOULD NOT BE USED AND WHAT ARE THE SIDE EFFECTS THAT MAY OCCUR?
No contraindications and no side effects (besides the eventual local tissue irritation) are known associated to the use of PYRALVEX.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
No drug interactions are known with this product.
Special precautions for use
Avoid gargling immediately after the application of PYRALVEX.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Although there are no studies available, the composition of the product and its topical action, do not seem to exclude its use during pregnancy and lactation.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
PYRALVEX does not affect the ability to drive and use machines.

LIST OF EXCIPIENTS
PYRALVEX contains ethanol and water as excipients.

WHEN AND HOW SHOULD PYRALVEX BE USED?
Apply the product on the inflamed areas of the mucosa several times a day. Avoid gargling right after the application.

WHAT TO DO IN CASE OF OVERDOSAGE AND INTOXICATION?
Depending on the severity of the situation, you should gargle several times with water and contact your doctor or go to the nearest Hospital.
Any side effect not included in this patient leaflet should be reported to your doctor or pharmacist.

Do not use after the expiry term stated on the package. Keep the vial tightly closed, protected from light and heat.

This leaflet was last reviewed in January 2003.

top