NOTICE
ANSM - Last updated: 07/01/2016
Name of the medicinal product
PAROEX 0.12 PER CENT, mouth wash solution
Chlorhexidine Digluconate
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS PAROEX 0.12 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE PAROEX 0.12 PER CENT, mouthwash solution?
3. HOW TO USE PAROEX 0.12 PER CENT, mouthwash solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PAROEX 0.12 PER CENT, mouthwash solution?
6. ADDITIONAL INFORMATION
1. WHAT IS PAROEX 0.12 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
STOMATOLOGY / LOCAL TREATMENT WITH ANTISEPTICAL SCREENING
(A: digestive system and metabolism)
Therapeutic indications
This medication is a mouthwash.
It is indicated for local topical treatment of infections of the mouth, or in care after surgery of the oral cavity.
2. BEFORE YOU USE PAROEX 0.12 PER CENT, mouthwash solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use PAROEX 0.12 PER CENT, mouthwash solution in the following cases:
· allergy to chlorhexidine or another component of the solution.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with PAROEX 0.12 PER CENT, mouth wash solution :
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Prolonged use of this medication is undesirable as it can alter the natural microbial balance of the mouth and throat.
If signs of infection worsen or if there is no improvement after 5 days:
CONSULT YOUR SURGER-DENTIST OR YOUR STOMATOLOGIST
Precautions for use
Do not get into eyes.
Do not insert the product into the nose or ears.
DO NOT LEAVE TO CHILDREN.
DO NOT SWALLOW.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Use of other medicines
Do not use several drugs containing an antiseptic at the same time or in close proximity.
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Effects on the ability to drive or use machines are not expected.
List of excipients with known effect
Excipient with a known effect : azorubine, polyoxyethylene castor oil, propylene glycol.
3. HOW TO USE PAROEX 0.12 PER CENT, mouthwash solution?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS
For each mouthwash, use the contents of a cup (12 ml-15 ml); if this presentation does not contain a cup, use a tablespoon, about 15 ml.
Rinse mouth thoroughly for about one minute with pure solution.
Method and route of administration
Use locally in mouthwash.
DO NOT SWALLOW.
This solution must be used pure, undiluted.
The mouthwash should be done AFTER brushing teeth and rinsing.
Frequency and timing of administration of the drug
The number of mouthwashes is 1 to 3 per day.
Duration of treatment
Do not continue treatment for more than 5 days without medical advice.
Symptoms and Instructions for Overdose
If you used more than 0.12% PAROEX, mouthwash solution:
If you accidentally swallow PAROEX 0.12 PER CENT, mouthwash solution, you may experience symptoms such as pain in the esophagus or stomach. In all cases, consult your dentist or stomatologist or doctor.
In the event of accidental spraying of the eyes, rinse immediately and abundantly with clear water and consult your doctor.
This specialty contains terpenic derivatives, as excipients, which can lower the epileptic threshold and lead to excessive neurological accidents in children (convulsions) and in elderly subjects (agitation type and confusion). Observe the recommended dosage and duration of treatment (see section "Dosage" and "Duration of treatment").
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, PAROEX 0.12 PER CENT, mouthwash solution is likely to have side effects, although not everyone is subject to it.
· Brown color of the tongue and teeth, especially among tea and coffee drinkers, disappearing when the treatment is discontinued.
· Possible allergic reactions: irritations, skin reactions, swelling of the salivary glands, swelling of the neck or face. If you experience any of these symptoms, stop treatment and see a doctor.
· Possibility of alteration of the taste or burning sensation of the tongue at the beginning of treatment.
· Occasionally, desquamation of the oral mucosa.
Declaration of side effects
If you experience any side effects, talk to 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. National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr. By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE PAROEX 0.12 PER CENT, mouthwash solution?
Keep out of the reach and sight of children.
Expiration date
Do not use PAROEX 0.12 PER CENT, mouth wash solution after the expiry date which is stated on the outer packaging.
Storage conditions
After opening the vial, this medication can be stored for up to 30 days (90 days for 5000 ml with pump).
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is PAROEX 0.12 PER CENT, mouthwash solution?
The active substance is :
Chlorhexidine Digluconate 20% (m / v) ....................................... ................................................. 0 , 6360 g
Amount corresponding to chlorhexidine digluconate ............................................ .......................... 0.1200 g
per 100 ml of mouthwash solution
The other components are :
Glycerol, acesulfame potassium, polyoxyethylene castor oil, propylene glycol, azorubine, aroma OPTAMINT 757515, purified water.
Pharmaceutical form and content
What is PAROEX 0.12 PER CENT, mouth wash solution and package contents:
This medication is in the form of a mouthwash solution. Bottle of 50 ml, 100 ml, 300 ml, 500 ml, 5000 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
SUNSTAR FRANCE
55/63, rue Anatole France
92300 LEVALLOIS PERRET
exploiting
CENTER PHARMACEUTICAL SPECIALTIES
76, avenue du Midi
63800 COURNON D'AUVERGNE
Maker
LICHTENHELDT GMBH PHARMAZEUTISCHE FABRIK
INDUSTRISTRASSE 7-9
23812 WAHLSTEDT
GERMANY
or
CHEMINEAU LABORATORIES
93 ROAD OF CURRENCY - BP 16
37210 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
