PYRALVEX*50+10MG/ML 10ML ORO-MUCOSAL

PYRALVEX 50 mg/ml + 10 mg/ml Gingival solution
Rhubarb glycoside extract and Salicylic acid

What it is and what it is used for
PYRALVEX is a topical medicine containing rhubarb extract and salicylic acid.
Rhubarb extract has an anti-inflammatory and analgesic action (helps relieve pain).
Salicylic acid is an antibacterial (used to treat bacterial infections).
PYRALVEX is used in adults and adolescents over 12 years of age for inflammation and minor localized infections in the mouth. Specifically in:
• Treatment of gingivitis (inflammation of the gums).
• Treatment of stomatitis (inflammation of the oral mucosa).
• Treatment of oropharyngitis (inflammation of the back of the mouth).
• Supportive treatment for other medications for alveolar pyorrhea (a disease characterized by the loosening of apparently healthy teeth).

Consult your doctor if you do not feel better or if you feel worse after 14 days.

What you need to know before taking the medicine
Do not use PYRALVEX
- if you are allergic to rhubarb extract and/or salicylic acid or any of the other ingredients of this medicine (listed in paragraph 6);
- if the person to be treated is a child under 12 years of age (see Children and How to use Pyralvex).

Warnings and precautions
Consult your doctor or pharmacist before using PYRALVEX.
Medicines for topical use, especially if applied repeatedly and for prolonged periods, can cause hypersensitivity (allergy).
In such cases, stop the treatment and consult your doctor to establish an appropriate therapy. (see paragraph Possible side effects).
Due to its ethanol (alcohol) content, the medicine is not suitable for alcoholics. It may cause a burning sensation on damaged skin.
For hygiene reasons, this medicine should only be used by one person.

Children
Do not give PYRALVEX to children under 12 years of age as high doses of salicylic acid (one of the active ingredients contained in this medicine) can cause a serious illness manifesting with uncontrollable vomiting, fatigue, memory loss, disorientation, and delirium, which can even lead to death (Reye's Syndrome).
However, no cases of this serious illness associated with the use of this medicine have been reported.

Possible side effects
Like all medicines, PYRALVEX can cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with PYRALVEX, STOP treatment with this medicine and contact your doctor immediately:
• allergic reaction whose symptoms may be:
- swelling of the face, mouth, and hands;
- difficulty breathing;
- skin rash.

Additionally, the following side effects have been observed:
Very common (may affect more than 1 in 10 people)
- transient burning sensation at the application site

Common (may affect up to 1 in 10 people)
- temporary staining of the teeth, easily removable with normal tooth cleaning;
- staining of the mouth.

Not known (frequency cannot be estimated from the available data)
- skin rash;
- hives.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.