PACKAGE LEAFLET: INFORMATION FOR THE USER

PYRALVEX 50 mg/ml + 10 mg/ml Gingival Solution

Glucidic extract of rhubarb and Salicylic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 14 days.

Contents of this leaflet:

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 is a topical medicinal product containing rhubarb extract and salicylic acid.
Rhubarb extract has anti-inflammatory and analgesic properties (helps relieve pain).
Salicylic acid is an antibacterial agent (used to treat bacterial infections).
PYRALVEX is used in adults and adolescents older than 12 years for inflammations
and minor localized infections in the mouth. Specifically for:

Treatment of gingivitis (inflammation of the gums).
Treatment of stomatitis (inflammation of the oral mucosa).
Treatment of oropharyngitis (inflammation of the back part of the mouth).
Adjunctive treatment with other medications for alveolar pyorrhea (a disease characterized by wobbling of apparently healthy teeth).

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

2. What you should know before using PYRALVEX

Do not use PYRALVEX

if you are allergic to rhubarb extract and/or salicylic acid or to any of the other ingredients of this medicine (listed in section 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
Talk to your doctor or pharmacist before using PYRALVEX.
Medicines for topical use, especially if applied repeatedly and for prolonged periods, may lead to hypersensitivity reactions (allergy).
If this occurs, stop treatment and consult your doctor to establish appropriate therapy (see section "Possible side effects").
Due to its ethanol (alcohol) content, this medicine is unsuitable for alcoholics.
It may cause a burning sensation on damaged skin.
For hygienic reasons, this medicine must be used exclusively by one person.

Children
Do not give PYRALVEX to children under 12 years of age, as the use of salicylic acid (one of the active substances contained in this medicine) at high doses may cause a serious illness characterized by uncontrollable vomiting, fatigue, memory loss, disorientation, and delirium, which may even lead to death (Reye's syndrome).
However, cases of this serious illness associated with the use of this medicine have not been reported.

Other medicines and PYRALVEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Clinically significant interactions may occur with heparin and oral anticoagulants (medicines that delay blood clotting and prevent thrombus formation).

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use PYRALVEX during the second and third trimesters of pregnancy only under direct medical supervision. Your doctor will prescribe PYRALVEX only if clearly necessary.
The use of PYRALVEX during the third trimester of pregnancy is not recommended.
Breastfeeding
At therapeutic doses of PYRALVEX, it is not known whether the active substances of the medicine are excreted in breast milk. Use PYRALVEX only under direct medical supervision. Your doctor will assess whether you should continue breastfeeding or start treatment with PYRALVEX, taking into account the benefits of breastfeeding for the child and the benefits of PYRALVEX therapy for you.
Fertility
If you are planning a pregnancy, contact your doctor before using PYRALVEX.
Your doctor will prescribe PYRALVEX only if clearly necessary.

Driving and using machines
PYRALVEX does not affect the ability to drive vehicles or operate machinery.

PYRALVEX contains ethanol
This medicine contains 476 mg of alcohol (ethanol) per ml, equivalent to 59.5% v/v.
PYRALVEX is flammable and must not be exposed to flames.

3. How to use PYRALVEX

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and adolescents from 12 years of age
The recommended dose is one application up to 3–4 times daily.
Do not exceed the maximum daily dose.
Paediatric population
PYRALVEX is contraindicated in children under 12 years of age (see “Do not use PYRALVEX” and
“Children”).
Duration of treatment
The maximum treatment duration is 14 days. Consult your doctor if symptoms do not improve or worsen.
Method of administration
Topical use.
Apply locally by painting (after removing dentures, if any) directly onto the affected area.
Do not rinse the mouth; do not eat or drink immediately after application.
If you use more PYRALVEX than you should
In case of accidental ingestion/overdose, inform your doctor immediately or go to the nearest hospital.
If you forget to use PYRALVEX
If you forget to use PYRALVEX, apply it as soon as you remember. Do not use a double dose to make up for the missed dose.
If you stop using PYRALVEX
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PYRALVEX may cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with PYRALVEX,
STOP using this medicine and contact your doctor immediately:
➢ allergic reaction, the symptoms of which may include:

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 discoloration of teeth, easily removed with normal tooth cleaning
mouth discoloration

Not known (frequency cannot be estimated from the available data)

skin rash
urticaria

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PYRALVEX

Close the bottle tightly after use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice obvious signs of deterioration of the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PYRALVEX contains
The active substances are rhubarb extract and salicylic acid.
Each ml of solution contains 50 mg of rhubarb extract (corresponding to 0.43 – 0.53% m/v of
anthraquinone derivatives) and 10 mg of salicylic acid.
The excipients are ethanol and purified water.

Description of the appearance of PYRALVEX and contents of the pack
PYRALVEX is a gingival solution for topical oral use, of brown mahogany colour.
Each carton contains one dark glass bottle containing 10 ml of solution and an applicator brush,
or one dark glass bottle containing 30 ml of solution and an applicator brush.
It is possible that not all pack sizes are 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
28100 DREUX (FRANCE)