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CORSODYL MINT FLAVOUR 0.2%W/V MOUTHWASH

Active substance: CHLORHEXIDINE DIGLUCONATE SOLUTION

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1.

NAME OF THE MEDICINAL PRODUCT
Corsodyl Mint Flavour 0.2% w/v Mouthwash

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 0.2% w/v
(equivalent to Chlorhexidine Digluconate Solution 1.028% w/w)
Also contains macrogolglycerol hydroxystearate. For full list of excipients, see
section 6.1.

3

PHARMACEUTICAL FORM
Mouthwash
A clear to slightly opalescent, transparent solution with an odour of peppermint.

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 toothbrushing cannot be adequately
employed (e.g. following oral surgery, in mentally or physically handicapped
patients).
Also for use in a post-peridontal surgery or treatment* regimen to promote gingival
healing.
*NB: 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
(e.g. 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.
The mouthwash is incompatible with anionic agents which are usually present in
conventional dentifrices. These should therefore be used before the mouthwash
(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 the 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
Oromucosal use. This product is not intended to be swallowed.

4.3

Contraindications
The product 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 oromucosal 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.
Macrogolglygerol hydroxystearate may cause skin reactions.

4.5

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

4.6

Fertility, pregnancy and lactation
There is no evidence of any adverse effects on the foetus arising from the use of
chlorhexidine digluconate 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 have 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 and anaphylaxis to
chlorhexidine have also been reported but are extremely rare.

4.9

Overdose
This has not been reported.
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
ATC code: A01A B03
Pharmacotherapeutic group: anti-infectives and antiseptics for local oral treatment
The 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
There are no preclinical data of relevance to the prescriber, which are additional to
those already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol
Macrogolglycerol Hydroxystearate
Sorbitol liquid (non-crystallising)
Peppermint flavour
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
30 months.
Shelf-life after opening: 3 months.

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 300 ml or 600 ml.

6.6

Special precautions for 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, U.K.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00079/0677

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/06/2013

10

DATE OF REVISION OF THE TEXT
08/11/2013

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Source: Medicines and Healthcare Products Regulatory Agency

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