PAROEX 1.2 MG / ML MOUTHWASH - patient leaflet, side effects, dosage

Patient leaflet - PAROEX 1.2 MG / ML MOUTHWASH

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 paroexif you are allergic (hypersensitive) to chlorhexidine, or any of the other ingredients of this medicine (listed in section 6).

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.

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.

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: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.

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- 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

LABORATOIRES CHEMINEAU

93 ROUTE DE MONNAIE – BP 16

37210 VOUVRAY