PYRALVEX 50 MG/ML + 10 MG/ML GINGIVAL SOLUTION 1 GLASS BOTTLE OF 10 ML

Name
PYRALVEX 50 mg/ml + 10 mg/ml Gingival Solution
Rhubarb glucoside extract and salicylic acid


What is it and what is it for?
PYRALVEX is a medicine for local use containing rhubarb extract and salicylic acid.
Rhubarb extract has anti-inflammatory and analgesic (helps relieve pain) effects.
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 of the mouth. In particular:
• Treatment of gingivitis (inflammation of the gums).
• Treatment of stomatitis (inflammation of the mucosa of the mouth).
• Treatment of oropharyngitis (inflammation of the back of the mouth).
• Supportive treatment with other drugs for alveolar pyorrhea (a disease characterized by loosening of apparently healthy teeth).

Talk to 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 section 6);
- if the subject to be treated is a child under 12 years of age (see "Children" and "How to use Pyralvex").


Warnings and precautions
Talk to your doctor or pharmacist before using PYRALVEX.
Medicines for local use, especially if applied for repeated and prolonged periods of time, can give rise to hypersensitivity (allergy) phenomena.
If this happens, stop treatment and consult your doctor to initiate appropriate therapy (see section "Possible side effects").
Due to its ethanol (alcohol) content, this medicine is not suitable for alcoholics. It may cause a burning sensation on damaged skin.
For hygiene reasons, this medicine must be used by one person only.

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


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 while taking PYRALVEX, STOP taking this medicine and contact your doctor immediately:
• allergic reaction whose symptoms may be:
- swelling of the face, mouth and hands;
- difficulty breathing;
- skin rash.

In addition, 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 tooth discoloration, easily removed with normal teeth brushing;
- mouth color.

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to 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.