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PAROEX 1.2 MG/ML MOUTHWASH

Active substance(s): CHLORHEXIDINE DIGLUCONATE

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INFORMATION FOR USE: INFORMATION FOR THE USER
Paroex 1.2 mg/ml, mouthwash
Active ingredient: chlorhexidine digluconate
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist or
nurse have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet:
1. What Paroex 1.2 mg/ml, mouthwash is and what is it used for
2. What you need to know before you use Paroex
3. How to use Paroex
4. Possible side effects
5. How to store Paroex
6. Contents of the pack and other information
1.
What Paroex 1.2 mg/ml, mouthwash is and what is it used for
Paroex 1.2 mg/ml, mouthwash contains the antiseptic ingredient chlorhexidine digluconate.
It is used in adults and children aged over 6 years as adjunctive treatment of oral mucosa
infections and post-operative care following dental surgery.
2.
What you need to know before you use Paroex
Do not use Paroex:
If you are allergic (hypersensitive) to chlorhexidine, or any of the other ingredients of this
medicine (listed in section 6).

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Warnings and precautions
For rinsing the mouth only - keep out of the eyes and ears, or other tissues except the inside of
your mouth. In case of contact with eyes, rinse immediately with water and contact your doctor
immediately. In case of contact with ears or other tissues, rinse with water.
Paroex should not be used if you have ulcers or peeling in the oral cavity.
Continuous rinsing of your mouth with Paroex instead of brushing your teeth may exacerbate
bleeding of the gums. Do not use for longer than 5 days at a time unless your doctor or dentist
advises a longer treatment. A continuous usage could increase the risk of bacterial or fungal
infections.
Chlorhexidine digluconate, the active substance in Paroex, may in rare cases cause severe
allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early
symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these
symptoms, stop using Paroex and contact your doctor as soon as possible (see under section 4:
“Possible side effects”).
Other medicines and Paroex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including medicines obtained without a prescription.
Paroex is incompatible with anionic agents, which are usually present in conventional tooth
pastes. Therefore, ideally use Paroex after brushing your teeth and rinsing the oral cavity
thoroughly with water.
Paroex with food and drink
Do not consume sugar-containing food or drinks within an hour of using Paroex.
Pregnancy and breast-feeding
There is limited experience with the use of Paroex in pregnant women. Also, it is not known
whether chlorhexidine is present in breast milk. Therefore, you should use Paroex with caution.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is not expected that using Paroex will affect your ability to drive and operate machinery.

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PAROEX contains azorubine (E122), castor oil hydrogenated, propyleneglycol
Azorubine (E122) may cause allergic reactions.
Macrogol glycerol hydroxystearate may cause skin reactions. In case of accidental ingestion, it
may cause stomach upset and diarrhoea.
Propyleneglycol may cause skin irritation.

3.
How to use Paroex
Always use this medicine exactly as described in this leaflet or as your doctor or your
pharmacist has told you. Check with your doctor or your pharmacist if you are not sure.
Unless otherwise prescribed, Paroex is to be used one to three times a day preferably after meals
and at a different time to brushing your teeth.
Rinse your mouth with 15 ml (1 cup up to the marking ring) of Paroex, mouthwash for one
minute and spit out, do not swallow and do not post-rinse. If the presentation does not include a
dosing cup, use a table spoon (15 ml).
If you use Chlorhexidine digluconate, mouthwash just after brushing, rinse your mouth
thoroughly with water before rinsing with Paroex.
PAROEX is ready for use and should not be diluted.
Duration of course of treatment
Paroex, mouthwash would normally not be used for longer than 5 days at a time. It may only be
used over a longer period if advised by your doctor or dentist.
Children over the age of 6 and the elderly
There are no special dosage recommendations for either elderly patients or children over the age
of 6. The normal adult dose is appropriate unless otherwise recommended by your doctor or
dentist.
If you use more Paroex than you should
When used as directed, the amounts of chlorhexidine absorbed by the oral mucosa can be
detoxified by the human body without toxic signs.
Therapeutic measures for detoxification are not necessary. In local overdose, Chlorhexidine
digluconate, mouthwash can be eliminated by rinsing with water.
This medicine also contains a certain ingredient which may trigger in high doses convulsions in
children and agitation/confusion in elderly subjects. Respect the posology and the recommended
duration of treatment.

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If you forget to use Paroex
Do not use a double dose to make up for a forgotten dose. Continue treatment as usual according
to the instructions.
If you have any further questions on the use of this product, ask your doctor, dentist, or
pharmacist.

4.
Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
In rare cases (seen in at least 1 in 10,000 patients, but in less than 1 in 1,000 patients), immediate
allergic reactions, contact allergy and urticaria. In isolated cases, severe allergic reactions with
symptoms such as breathing problems, swelling around the eyes, low blood pressure, shock have
also been reported after local application of chlorhexidine.
Should you suffer from anaphylactic or allergic reactions, please contact your doctor
immediately.
With oral administration, reversible discoloration of hard dental tissues, restorations and lingual
papillae (glossotrichia) may occur. Brownish discoloration of the teeth may occur.
By reducing the consumption of tea, coffee and red wine, these symptoms can be prevented.
Wound healing disorders are possible.
At the start of treatment, a burning sensation on the tongue may occur. The following may also
occur: Reversible impairment of taste sensation, reversible numbness of the tongue.
These symptoms generally improve over the course of use of Paroex, mouthwash. If the
symptoms still persist after cessation of treatment, consult a doctor or pharmacist.
In rare cases (seen in at least 1 in 10,000 patients, but in less than 1 in 1,000 patients) regular
use may lead to bleeding of gums after brushing teeth.
In rare cases (seen in at least 1 in 10,000 patients, but in less than 1 in 1,000 patients)
increased tartar formation may occur.
In very rare cases (seen in at least 1 in 100,000 patients, but in less than 1 in 10,000 patients),
irritation of the mucosa in the mouth, peeling of the mucosa in the mouth may occur.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple
App Store

By reporting side effects you can help provide more information on the safety of this medicine.

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5.

How to store Paroex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The product should be discarded 1 month after first opening (50, 100, 300 and 500 ml bottles) or
3 months after first opening (5L bottle).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Paroex contains
- The active substance is chlorhexidine digluconate. 1 ml contains 6.36 mg of chlorhexidine
digluconate solution 20% (w/v). One ml contains 1.2 mg chlorhexidine digluconate.
- Other ingredients are glycerol, potassium acesulfam, macrogolglycerol hydroxystearate,
propyleneglycol, azorubine, Optamint flavour, purified water.
What Paroex looks like and contents of the pack
PAROEX, mouthwash is clear red solution.
Package size: bottles containing 50, 100, 300, 500 and 5000 ml.
Marketing authorisation holder
SUNSTAR FRANCE
55/63 rue Anatole France
92300 LEVALLOIS PERRET
FRANCE
Manufacturer
LICHTENHELDT GmbH PHARMAZEUTISCHE FABRIK
Industristrasse 7-9
23812 WAHLSTEDT
GERMANY
or
LABORATOIRES CHEMINEAU
93 ROUTE DE MONNAIE - BP 16
37210 VOUVRAY
FRANCE
On request, this leaflet is available in formats suitable for the blind and partially-sighted.
This leaflet was last revised in 07/2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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