GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Corsodyl 0.2% w/v Mint Mouthwash

Chlorhexidine Digluconate 0.2% w/v

(as Chlorhexidine Digluconate Solution)

Excipients: Contains Macrogolglycerol Hydroxystearate 0.8% w/v

For a full list of excipients, see section 6.1.

Mouthwash

A clear or slightly opalescent, colourless solution with an odour of peppermint.

For the 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 or in physically or mentally handicapped patients).

Also for use in a post-periodontal surgery or treatment regimen to promote gingival healing.

It is useful in the management of aphthous ulceration and oral candidal infections (e.g. denture stomatitis and thrush).

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 with 10 ml for one minute prior to treatment.

Corsodyl Mouthwash is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl 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 denture stomatitis the dentures should be cleansed and soaked in Corsodyl Mouthwash for fifteen minutes twice daily.

Children and the Elderly

There are no special dosage recommendations for either elderly patients or children of 12 years and over. The normal adult dose is appropriate 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.

Corsodyl Mouthwash is contra-indicated for patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.

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.

A discoloration of the teeth and tongue may occur. The stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine.

Chlorhexidine is incompatible with anionic agents.

There is no evidence of any adverse events on the foetus arising from the use of Corsodyl Mint Mouthwash during pregnancy or lactation. Therefore, no special precautions are recommended.

None have been reported or are known.

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 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 the 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 tooth brushing is not possible, as for example with intermaxillary fixation, or with extensive orthodontic applicances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste

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 healthcare professional.

Oral desquamation

In cases where oral desquamation occurs, dilution of the mouthwash using 5ml water with 10ml mouthwash, 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 discontinuation of 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.

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. Due to the alcohol content (7 % v/v), ingestion of large amounts by children requires attention, seek medical advice for appropriate action.

Corsodyl Mouthwash contains 0.2% w/v chlorhexidine gluconate 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.

Pre-clinical safety studies carried out on chlorhexidine gluconate have not revealed any pertinent findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in the Summary.

Sorbitol 70% (non-crystallising)

Ethanol (96%)

Macrogolglycerol hydroxystearate

Peppermint oil

Purified water

Chlorhexidine is incompatible with anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine.

Three years.

Do not store above 25^oC. Store in the original container in order to protect from light.

Container

Amber coloured, oriented polyethylene terephthalate (PET) bottles of 300 ml nominal capacity.

Closure

Wadless screw caps made from white, food grade polypropylene.

No special requirements.

GlaxoSmithkline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/2/2

30 September 1976/10 January 2010

September 2010