GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Corsodyl 1% w/w Dental Gel

Chlorhexidine Digluconate 1.0% w/w (as Chlorhexidine Digluconate Solution)

Excipients: Contains Macrogolglycerol Hydroxystearate1% w/w

For a full list of excipients, see section 6.1.

Dental Gel

A clear or faintly opalescent, transparent, colourless or slightly coloured gel with an odour of peppermint.

For the inhibition of the formation of dental plaque.

As an aid in the treatment and prevention of gingivitis

As an aid to maintaining oral hygiene.

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

It is useful in the management of recurrent aphthous ulceration.

It is useful in the management of recurrent oral candidal infections.

It may also be used as part of a preventative programme to help reduce caries activity.

Adults:

Brush the teeth thoroughly with one inch of gel on a moistened toothbrush, once or twice daily for about one minute.

For the treatment of gingivitis, a course of about one month is advisable.

When used for the management of aphthous ulceration and oral candidal infections an alternative method of delivery may be required which facilitates application of the gel to the affected areas. This should be used once or twice daily for about one minute. The length of treatment time should be decided on the basis of clinical response.

During the treatment of denture stomatitis the dentures should be cleansed and soaked in Corsodyl Mouthwash for 15 minutes twice daily, or as directed by the dentist.

For the prevention of caries, 1-2 inches of 'Corsodyl' Dental Gel should be applied to the teeth daily, preferably by close-fitting tray, remaining in contact with the teeth for 5 minutes. The treatment should be continued for up to 14 days. At the same time the patient should be encouraged to undertake adjunctive preventive measures, such as reducing the frequency of intake of refined carbohydrates and brushing the teeth twice daily with a fluoride-containing dentifrice. Additionally professional fluoride applications and fissure sealing may be useful as part of the preventative programme.

Corsodyl Dental Gel is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl (rinsing the mouth and toothbrush between applications) or at a different time of day.

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 Dental Gel is contraindicated 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 gel 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 effects on the foetus arising from the use of Corsodyl Dental Gel during pregnancy or lactation. Therefore, no special precautions are recommended.

None have been reported or are known.

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.

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 gel. 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.

Transient disturbances of taste sensation and a numbness, tingling or burning sensation of the tongue may occur on initial use of the gel. These effects usually diminish with continued use. If the condition persists, consult a healthcare professional

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.

Corsodyl 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.

Hyprolose

Macrogolglycerol Hydroxystearate

Sodium acetate

Levomenthol

Peppermint Oil

Isopropyl Alcohol

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°C.

Container

Collapsible internally-lacquered aluminium tubes.

Closure

White, food grade HDPE cap. Wadless with plug seal.

Pack size

50 g

No special requirements

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/2/1

29 April 1975/ 10 January 2010

September 2010