Patient Information Leaflet

CORSODYL
0.2% w/v, mouthwash
Chlorhexidinum gluconatum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

Table of contents

What Corsodyl is and what it is used for
Important information before using Corsodyl
How to use Corsodyl
Possible side effects
How to store Corsodyl
Contents of the pack and other information

1. What Corsodyl is and what it is used for

Corsodyl mouthwash contains chlorhexidine gluconate, which has antibacterial properties.
Indications for Corsodyl mouthwash:
Inhibition of dental plaque formation.
Adjunctive treatment and prevention of gingivitis, and maintenance of oral hygiene, especially in situations where proper tooth brushing is not possible (e.g. after oral surgical procedures, or in physically or mentally disabled patients).
Use after periodontal surgery to promote healing of the gums.
Supportive treatment of aphthae and fungal infections of the oral cavity (e.g. denture stomatitis and oral candidiasis).

2. Information before using Corsodyl

When not to use Corsodyl
If the patient is allergic to chlorhexidine or to any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Corsodyl, discuss this with your doctor, pharmacist,
or nurse.
For oral use only (for external use). Protect eyes and ears from contact with the medicine.
If the solution gets into the eyes, rinse immediately and thoroughly with water.
Do not swallow the solution.
If pain, swelling or irritation of the mouth occurs, discontinue use and contact your doctor.
Discontinue use of Corsodyl and consult your doctor if a rash, swelling of the lips, tongue, throat or face, or difficulty breathing occurs.
Superficial discolouration of the tongue may occur, which resolves after stopping treatment. Discolouration of teeth and fillings may also occur. This discolouration is not permanent and can be largely prevented by limiting consumption of coffee, tea and red wine, and by daily brushing of teeth with toothpaste before using the solution. In the case of dentures, clean them with a denture cleaning agent. However, in some cases professional polishing of teeth may be necessary to completely remove stains. Poorly cleaned discoloured fillings with irregular edges or rough surfaces may require replacement. In situations where tooth brushing is not possible, such as facial trauma treated with intermaxillary elastics or use of orthodontic appliances, removal of dental calculus and polishing of teeth may also be required.
Corsodyl solution is incompatible with anionic agents, which are commonly found in toothpastes. Therefore, after brushing teeth, rinse the mouth thoroughly with water and wait 5 minutes before using Corsodyl. Alternatively, Corsodyl may be used at a different time of day.
During initial use of the oral solution, temporary disturbances in taste sensation or a burning, tingling or numbing sensation of the tongue may occur. These effects usually diminish with continued use.
If the above symptoms persist, consult your doctor.
If desquamation of the oral mucosa occurs, dilute the solution with an equal amount of water and mix well, which often allows continued use.

Corsodyl with other medicines
Chlorhexidine is incompatible with anionic substances, including ingredients found in toothpastes.

Pregnancy, breastfeeding and fertility
For external use only. No special precautions are recommended.

Driving and operating machinery
For external use only. The effect on the ability to drive and operate machinery is unknown.

Corsodyl contains glycerol, sorbitol and a fragrance
Glycerol
The medicine contains 500 mg of glycerol in each dose (10 ml). The medicine may cause headache, gastrointestinal disturbances and diarrhoea.
Sorbitol
The medicine contains 1.05 mg of sorbitol in each dose (10 ml).
Fragrance
The medicine contains a fragrance containing benzyl alcohol, citral, geraniol, limonene, linalool, eugenol and citronellol. These may cause allergic reactions.

3. How to use Corsodyl

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Use in adults
Method of use: rinse the mouth thoroughly twice daily with 10 ml of the solution for about one minute.

Before dental procedures: rinse the mouth with 10 ml of the solution for one minute.

In the treatment of gingivitis, a course lasting approximately one month is recommended.

For aphthous ulcers and oral candidiasis, treatment should be continued for 48 hours after clinical signs of healing have been achieved.

In the treatment of denture stomatitis, after cleaning the dentures, soak them twice daily in Corsodyl solution for fifteen minutes.

Do not use the product for longer than 4 weeks unless otherwise advised by a doctor.

Do not exceed the recommended dose.

Use in elderly patients and children over 12 years of age
There are no special dosage recommendations for elderly patients or children over 12 years of age. The usual adult dose is appropriate unless otherwise directed by a dentist.

Use in children
Corsodyl should not be used in children under 12 years of age without medical advice.

Use of a higher than recommended dose of Corsodyl
No cases of overdose have been reported.

Accidental swallowing
Chlorhexidine is poorly absorbed when taken orally. Even after swallowing significant amounts, systemic adverse effects are unlikely.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions are listed below according to their frequency of occurrence.
The following adverse reactions may occur:
Very common (affecting more than 1 in 10 patients):

coated tongue.

Common (affecting less than 1 in 10 patients, but more than 1 in 100 patients):

dryness and burning sensation in the mouth,
loss of taste / taste disturbance,
tongue pain,
sensory disturbances (paraesthesia) / numbness in the oral cavity.

Single reported cases:

discoloration of teeth and tongue,
irritation of the oral cavity,
desquamation and (or) swelling of the oral mucosa,
swelling of the parotid glands,
breathing difficulties,
rash,
hypersensitivity and anaphylactic reactions (swelling of lips, tongue, throat, face).

In some individuals during treatment with Corsodyl other adverse reactions may occur. If any adverse effects not listed in this leaflet occur, they should be reported to a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Corsodyl

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must 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 pack and other information

What Corsodyl contains

The active substance is chlorhexidine gluconate.
The other ingredients are: glycerol, macrogol glycerol hydroxystearate, non-crystallizing liquid sorbitol, Optamint 291616 flavour (containing benzyl alcohol, citral, geraniol, limonene, linalool, eugenol and citronellol), purified water.

What Corsodyl looks like and contents of the pack
300 ml bottle
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
Omega Pharma Manufacturing GmbH&Co.
KG, Benzstrasse 25,
D-71083 Herrenberg,
Germany
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products