Paroex

Leaflet attached to the packaging: information for the user

Paroex, 1.2 mg/mL, mouthwash solution

Chlorhexidine digluconate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Paroex and what is it used for
• 2. Important information before using Paroex
• 3. How to use Paroex
• 4. Possible side effects
• 5. How to store Paroex
• 6. Contents of the packaging and other information

1. What is Paroex and what is it used for

Paroex mouthwash solution contains the antiseptic active substance chlorhexidine digluconate, used for local treatment inside the mouth. The medicine is used in adults and children over 6 years of age as an adjunctive treatment for infections of the oral mucosa and post-operative care after dental surgery. If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

2. Important information before using Paroex

When not to use Paroex

Warnings and precautions

For mouthwash use only - avoid contact with eyes and ears and any other tissue except the oral mucosa. In case of eye contact, rinse immediately with water and contact a doctor. In case of ear contact or other tissues, rinse with water. This product is not intended for swallowing. Therefore, it should only be used in patients who are able to rinse their mouths. Paroex should not be used if the patient has ulcers and desquamation of the oral mucosa. Long-term mouthwash with Paroex instead of toothbrushing may increase gum bleeding. Do not use for more than 5 days, unless a doctor or dentist recommends longer treatment. Long-term use may increase the risk of bacterial or fungal infections. Chlorhexidine digluconate, the active substance of Paroex, may rarely cause severe allergic reactions, leading to a drop in blood pressure and even loss of consciousness. Early symptoms of a severe allergic reaction may include skin rash or asthma. If these symptoms occur, stop using Paroex and contact a doctor as soon as possible (see section 4 "Possible side effects"). Reversible brown discoloration of teeth, fillings, and tongue surface may occur. These symptoms can be prevented by reducing the consumption of tea, coffee, and red wine. At the beginning of treatment, a burning sensation of the tongue may occur. A decrease in taste or numbness of the tongue may also occur. These symptoms usually improve during treatment. If the symptom persists after stopping treatment, consult a doctor or pharmacist.

Paroex and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. Paroex is incompatible with anionic agents, which are usually present in conventional toothpastes and other products commonly used locally in the mouth (chewing gum, nicotine substitutes, mouthwashes, dissolvable tablets...). Paroex should therefore be used at a different time or after using these products. Before using Paroex 1.2 mg/ml mouthwash solution, rinse your mouth with water. Do not consume food or drinks containing sugar immediately after using the medicine, as this reduces its effectiveness.

Using Paroex with food and drink

Do not consume food or drinks containing sugar within one hour after using Paroex.

Pregnancy and breastfeeding

Experience with the use of Paroex in pregnant women is limited. It is also unknown whether chlorhexidine passes into breast milk. Therefore, caution should be exercised when using Paroex. 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 using this medicine.

Driving and using machines

Paroex is not expected to affect the ability to drive or use machines.

Paroex contains azorubine (E 122), macrogol glycerol hydroxystearate, propylene glycol

Azorubine (E 122) may cause allergic reactions. Macrogol glycerol hydroxystearate may cause allergic reactions. In case of accidental swallowing, it may cause stomach upset and diarrhea. Propylene glycol may cause skin irritation.

3. How to use Paroex

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Unless otherwise instructed, Paroex should be used one to three times a day, preferably after meals and at times other than toothbrushing. The proposed dosing schedule is suitable for adults and children over 6 years of age. Children under 6 years of age should not use Paroex 1.2 mg/ml. Administration: Apply to the oral mucosa. Rinse the mouth with 15 ml (1 measuring cup to the ring mark) of Paroex for one minute and spit it out. Do not swallow or rinse your mouth again. If the packaging does not contain a measuring cup, use a tablespoon (15 ml). If Paroex is used immediately after toothbrushing, rinse your mouth thoroughly with water before using the medicine. Paroex mouthwash solution is ready to use and should not be diluted. Duration of treatment: Paroex mouthwash solution should not be used for more than 5 days. The medicine can only be used for a longer period if recommended by a doctor or dentist.

Using a higher dose of Paroex than recommended

When used as directed, the amounts of chlorhexidine absorbed through the oral mucosa can be eliminated by the human body without harmful symptoms. No treatment is necessary to counteract the effects. In case of local overdose, chlorhexidine digluconate mouthwash solution can be removed by rinsing with water. This medicine also contains an ingredient that may cause convulsions in children and excitement/confusion in the elderly at high doses. Follow the dosing and recommended treatment duration.

Missing a dose of Paroex

Do not take a double dose to make up for a missed dose. Continue treatment as before, following the recommendations. If you have any further questions about using this medicine, consult a doctor, dentist, or pharmacist.

4. Possible side effects

Like all medicines, Paroex can cause side effects, although not everybody gets them. In rare cases (may affect up to 1 in 1000 people), immediate allergic reactions, contact allergy, and urticaria occur. In individual cases, after local use of chlorhexidine, severe allergic reactions with symptoms such as difficulty breathing, swelling around the eyes, low blood pressure, and shock have been reported. If anaphylactic or allergic reactions occur, contact a doctor immediately. Other side effects: Uncommon (may affect up to 1 in 100 people):

• After oral administration, reversible brown discoloration of teeth, fillings, and tongue may occur. These symptoms can be prevented by reducing the consumption of tea, coffee, and red wine.

Rare (may affect up to 1 in 1,000 people):

• increased plaque formation
• bleeding gums after toothbrushing (with regular use)

Very rare (may affect up to 1 in 10,000 people):

• irritation of the oral mucosa
• desquamation of the oral mucosa

Frequency not known (frequency cannot be estimated from the available data):

• burning sensation or numbness of the tongue*.
• reversible disturbance of taste*
• parotid gland inflammation
• allergic contact dermatitis

*These symptoms usually improve during treatment with Paroex. If the symptoms persist after stopping treatment, consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa; tel: +48 22 492 13 01; fax: + 48 22 492 13 09; e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. 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 stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special precautions for storage. The product should be discarded after 1 month from first opening (50 mL, 100 mL, 300 mL, and 500 mL bottles) or after 3 months from first opening (5 L bottle). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Paroex contains

• The active substance is chlorhexidine digluconate. 1 mL contains 6.36 mg of 20% (w/v) chlorhexidine digluconate solution. Each mL contains 1.2 mg of chlorhexidine digluconate.
• The other ingredients are glycerol, sucralose, macrogol glycerol hydroxystearate, propylene glycol, azorubine (E 122), Optamint - flavor and fragrance correcting agent (contains menthol, anethole, eucalyptol, peppermint essential oil, menthone, menthyl acetate, racemic menthol, propylene glycol, triacetin, star anise essential oil, sweet fennel essential oil, vanillin, maltol, tangerine essential oil, ethanol), purified water.

What Paroex looks like and contents of the pack

Paroex, mouthwash solution is a clear, red solution. Pack sizes: bottles containing 50 ml, 100 ml, 300 ml, 500 ml, and 5 L.

Marketing authorization holder and manufacturer

105 rue Jules Guesde
92300 Levallois Perret
France

Manufacturer

Lichtenheldt GmbH Pharmazeutisch Fabrik

Industristrasse 7
23812 Wahlstedt
Germany

Laboratoires Chenineau

93 Route de Monnaie
37210 Vouvray
France
This leaflet is available in a format suitable for the blind and partially sighted upon request. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
DE: Paroex 1,2 mg/ml, Mundwasser
AT: Parosept 1,2 mg/ml, Mundwasser
BE: Parosept 1,2 mg/ml, solution pour bain de bouche
CZ: Perioxept
DK: Paroex 1,2 mg/ml, mundskyllevæske
ES: Paroex 1,2 mg/ml, solucion para enjuague bucal
FI: Parosept 1,2 mg/ml, Suuvesi
IT: Paroex 1,2 mg/ml, collutorio
NL: Perioxept 1,2 mg/ml, mondspoeling
NO: Paroex
PL: Paroex
PT: Paroex 1,2 mg/ml, solução para lavagem da boca
UK: Paroex 1.2 mg/ml, mouthwash
SE: Parosept 1,2 mg/ml, munsköljvätska

Date of last revision of the leaflet: 03/2021

5/5