This information is intended for use by health professionals

1. Name of the medicinal product

Corsodyl 1% w/w Dental Gel

2. Qualitative and quantitative composition

Chlorhexidine Digluconate 1.0% w/w

(equivalent to Chlorhexidine Digluconate Solution Ph. Eur. 5.325 % w/w)

3. Pharmaceutical form

Oromucosal gel.

4. Clinical particulars
4.1 Therapeutic indications

Inhibition of 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-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 recurrent aphthous ulceration.

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

As an aid in the prevention of dental caries in high-caries-risk patients (for example xerostomia sufferers), when used in a regimen as an adjunct to fluoride.

4.2 Posology and method of administration

Adults:

Brush the teeth thoroughly with one inch of gel on a moistened toothbrush, once or twice daily for about one minute. Spit out any excess. Do not rinse after applying gel.

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 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.

When used as part of a regimen to prevent dental caries the gel should be applied for 5 minutes nightly for 14 days in a close fitting tray. This treatment should be repeated every 3-4 months or as directed by the dentist. When used as part of a regimen to prevent dental caries of remaining teeth in denture wearers the gel may be applied to the fitting surface of the denture before insertion.

During the treatment of denture stomatitis, thoroughly brush all over the dentures with 2.5 cm of gel on a moistened toothbrush, once or twice daily for about one minute.

Do not exceed the stated dose.

Children and Elderly patients:

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:

For oral (external) use only.

4.3 Contraindications

Corsodyl dental gel 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 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.

Corsodyl 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.

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 gel. These effects usually diminish with continued use. If the condition persists, consult a healthcare professional.

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 tooth coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement.

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 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

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 frequency.

Clinical Trial Data

Gastrointestinal Disorders

Very Common:

Tongue coated

Common:

Dry mouth

Nervous system disorders

Common:

Aguesia / dysguesia

Glossodynia

Oral paraesthesia / hypoaesthesia

Post Marketing Data

Gastrointestinal Disorders

Isolated reports:

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

Isolated reports:

Hypersensitivity and anaphylaxis (see 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.

4.9 Overdose

This has not been reported.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large amounts 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

Chlorhexidine 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 bonds strongly to skin, mucosa and other 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

Hydroxypropylcellulose,

Macrogolglycerol hydroxystearate,

Sodium acetate,

Levomenthol,

Peppermint oil,

Isopropyl alcohol,

Purified water.

6.2 Incompatibilities

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

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Collapsible internally lacquered aluminium tubes. White food grade HDPE cap, wadless with plug seal.

Tube size 50 grams.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0062

9. Date of first authorisation/renewal of the authorisation

10 February 1994 / 09 September 2008

10. Date of revision of the text

30 September 2016