CORSODYL ORIGINAL Mouthwash Ref.[2644] Active ingredients: Chlorhexidine

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.

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.

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 mouthwash. 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. 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.

Chlorhexidine is incompatible with anionic agents.

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.

None have been reported or are known.

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. or search for MHRA Yellow Card in the Google Play or Apple App Store.

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