CORSODYL MINT MOUTHWASH
Active substance(s): CHLORHEXIDINE DIGLUCONATE SOLUTION / CHLORHEXIDINE DIGLUCONATE SOLUTION / CHLORHEXIDINE DIGLUCONATE SOLUTION
NAME OF THE MEDICINAL PRODUCT
Corsodyl Mint Mouthwash
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 0.2% w/v
(equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v)
For inhibition of the formation of dental plaque.
As an aid in the treatment and prevention of gingivitis and in the maintenance
of oral hygiene, particularly in situations where tooth brushing cannot be
adequately employed (eg following oral surgery, in mentally or physically
Also for use in a post-peridontal surgery or treatment* regimen to promote
*N.B: Use as part of a post-periodontal treatment regimen has only been
adequately studied over the short term and following standard root surface
It is useful in the management of aphthous ulceration and oral candidal infections (eg
denture stomatitis and thrush)
Posology and method of administration
Thoroughly rinse the mouth for about one minute with 10 ml twice daily. Spit
out after use. In the dental surgery the patient should be instructed to rinse the
mouth for one minute prior to treatment.
For the treatment of gingivitis a course of about one month is advisable
although some variation in response is to be expected. In the case of aphthous
ulceration and oral candidal infections treatment should be continued for 48
hours after clinical resolution. For the treatment of dental stomatitis the
dentures should be cleansed and soaked in Corsodyl Mouthwash for fifteen
minutes twice daily.
Do not exceed the stated dose.
Children and the Elderly:
The normal adult dose is appropriate for elderly patients and children of 12
years and over unless otherwise recommended by the dentist or the physician.
Children under 12 years of age should not use the product unless
recommended by a healthcare professional.
Route of administration:
External (oral) use. [This product is not intended to be swallowed].
Corsodyl is contraindicated for patients who have previously shown a
hypersensitivity reaction to Chlorhexidine or to any of the excipients in the
formulation. However, such reactions are extremely rare.
Special warnings and precautions for use
For oral (external) use only. Do not swallow. Keep out of the eyes and ears.
If the mouthwash comes into contact with the eyes, wash out promptly and
thoroughly with water.
In case of soreness, swelling or irritation of the mouth, stop using the product and
consult a healthcare professional.
Corsodyl is incompatible with anionic agents which are usually present in
conventional toothpastes. These should therefore be used before Corsodyl (rinsing the
mouth between applications) or at a different time of day.
In case of, swelling, or difficulty breathing stop using the product and seek immediate
medical help. Transient disturbances of taste sensation and a numbness, tingling or
burning sensation of the tongue may occur on initial use of the mouthwash. These
effects usually diminish with continued use. If the condition persists, consult a
Discoloration of the teeth and tongue may occur. The stain is not permanent and can
largely be prevented by reducing the consumption of dietary chromagens such as tea,
coffee or red wine. In the case of dentures this can be prevented by cleaning with a
conventional denture cleaner. In certain cases professional treatment (scaling and
polishing) may be required to remove the stain completely. Stained anterior toothcoloured restorations with poor margins or rough surfaces which are not adequately
cleaned by professional prophylaxis may require replacement. Similarly where
normal toothbrushing is not possible, for example with intermaxillary fixation, or
with extensive orthodontic appliances, scaling and polishing may also be required
once the underlying condition has been resolved.
Interaction with other medicinal products and other forms of interaction
Chlorhexidine is incompatible with anionic agents.
Fertility, Pregnancy and lactation
There is no evidence of any adverse effects on the foetus arising from the use of
Corsodyl during pregnancy or on infants during lactation. Therefore no special
precautions are recommended.
Effects on ability to drive and use machines
None have been reported or are known.
Adverse events are listed below by system organ class and frequency. Frequencies are
defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000
to <1/100); rare (≥1/10,000 to <1/1000); and very rare (<1/10,000). The data from
clinical trials are estimates. Post-marketing data refer to reporting rate rather than true
Clinical Trial Data
Very Common: Tongue coated
Nervous system disorders
Aguesia / dysguesia
Oral paraesthesia / hypoaesthesia
Post Marketing Data
Discoloration of the teeth and tongue (see section 4.4)
Irritation of the mouth (see section 4.4)
Desquamation / swelling of oral mucosa (see section 4.4)
Parotid gland swelling
Immune System Disorders
Hypersensitivity and anaphylaxis (section 4.3 and 4.4)
Undesirable effects are generally minor and local in nature.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
This has not been reported.
Due to the alcohol content (7.0% v/v), ingestion of large amounts by children
requires attention, seek medical advice for appropriate action.
Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic
effects are unlikely even if large volumes are ingested. However, gastric lavage may
be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures
Corsodyl Mint Mouthwash contains 0.2% w/v chlorhexidine digluconate which is an
antimicrobial preparation for external use. It is effective against a wide range of
Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and
lipophilic viruses. It is active against a wide range of important oral pathogens and is
therefore effective in the treatment of many common dental conditions.
Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and
tissues and is thus very poorly absorbed. No detectable blood levels have been found
following oral use.
Preclinical safety data
No information further to that contained in other sections of the SPC is included.
List of excipients
Ethanol (96 per cent), Macrogolglycerol hydroxystearate, Sorbitol 70 per cent (noncrystallising), Peppermint oil, Purified water.
Hypochlorite bleaches may cause brown stains to develop in fabrics that have
previously been in contact with preparations containing chlorhexidine.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Oriented amber polyethylene terephthalate bottle with plastic screw cap made
from white food grade polypropylene.
Each bottle contains 300ml or 600ml.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
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.