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CORSODYL MINT MOUTHWASH

Active substance: CHLORHEXIDINE DIGLUCONATE SOLUTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Corsodyl Mint Mouthwash

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 0.2% w/v
(equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v)

3.

PHARMACEUTICAL FORM
Oromucosal solution

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
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
handicapped patients).
Also for use in a post-peridontal surgery or treatment* regimen to promote
gingival healing.
*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
instrumentation
It is useful in the management of aphthous ulceration and oral candidal
infections (eg denture stomatitis and thrush)

4.2.

Posology and method of administration

Adults:
Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In
the dental surgery the patient should be instructed to rinse the mouth for one
minute prior to treatment.
Corsodyl is incompatible with anionic agents which are usually present in
conventional dentifrices. These should therefore be used before Corsodyl
(rinsing the mouth between applications) or at a different time of day.
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.
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].

4.3.

Contraindications
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.

4.4.

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.

4.5

Interaction with other medicinal products and other forms of interaction
Chlorhexidine is incompatible with anionic agents.

4.6.

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.

4.7.

Effects on ability to Drive and Use Machines
None have been reported or are known.

4.8

Undesirable effects
Discoloration: A superficial discoloration of the dorsum of the tongue may
occur. This disappears after treatment is discontinued. Discoloration of the
teeth and silicate or composite restorations may also occur. This stain is not
permanent and can largely be prevented by reducing the consumption of tea,
coffee and red wine and brushing with a conventional toothpaste daily before
using the mouthwash, or, in the case of dentures, cleaning with a conventional
denture cleaner. However, in certain cases a professional prophylaxis (scaling
and polishing) may be required to remove this stain completely. Stained
anterior tooth-coloured 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.
Taste: Transient disturbance of taste sensation and a burning sensation of the
tongue may occur on initial use of the mouthwash. These effects usually
diminish with continued use.
Oral desquamation: In cases where oral desquamation occurs dilution of the
mouthwash with an equal volume of tap water, freshly mixed, will often allow
continued use of the mouthwash.
Parotid gland swelling: Very occasionally, swelling of the parotid glands
during the use of chlorhexidine mouthrinses has been reported. In all cases
spontaneous resolution has occurred on discontinuing treatment.
Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations
can occasionally occur.
Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to
chlorhexidine have also been reported but are extremely rare.

4.9.

Overdose
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 as appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2.

Pharmacokinetic Properties
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.

5.3.

Preclinical Safety Data
No information further to that contained in other sections of the SPC is
included.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Ethanol (96 per cent), Macrogolglycerol hydroxystearate, Sorbitol 70 per cent
(non-crystallising), Peppermint oil, Purified water.

6.2.

Incompatibilities
Hypochlorite bleaches may cause brown stains to develop in fabrics that have
previously been in contact with preparations containing chlorhexidine.

6.3.

Shelf Life
Three years.

6.4.

Special Precautions for Storage
Store below 25°C.

6.5.

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.

6.6.

Instructions for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Beecham Group plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as:

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00079/0312

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/09/2008

10

DATE OF REVISION OF THE TEXT
26/03/2009

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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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