Chlorhexidine gluconate 0.12% oral rinse

Chlorhexidine gluconate 0.12% oral rinse Medicine

Overdose

Chlorhexidine Gluconate 0.12% Oral Rinse is poorly absorbed by the oral route; therefore systemic effects are unlikely even if large volumes are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.

Incompatibilities

Care Chlorhexidine Gluconate 0.12% Oral Rinse Antiseptic Mouthwash is incompatible with anionic agents which are often present in toothpastes. Therefore these should be used before the mouthwash, rinsing the mouth between applications, or at a different time of day.

Undesirable effects

Skin disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune disorders

Frequency not known: Hypersensitivity including anaphylactic shock.

A superficial discolouration of the dorsum of the tongue may occur which disappears after discontinuation of treatment. Discolouration of the teeth and silicate or composite restorations may also occur. The discolouration is not permanent and may be prevented by brushing daily with conventional toothpaste prior to using the mouthwash and avoiding tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and polishing) may be necessary to completely remove the stain.

Transient disturbances of taste and a burning sensation of the tongue may occur on initial use of the mouthwash but usually diminishes with continued use.

In cases where oral desquamation occurs it may be necessary to discontinue treatment.

Very occasionally, swelling of the parotid glands during use has been reported. If this happens stop using the product and the effect should go away.

In all cases spontaneous resolution has occurred on discontinuation of treatment.

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 Care Scheme at: www.mhra.gov.uk/yellowcard.

Preclinical safety data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

Pharmacodynamic properties

A01A B03 - Stomatological preparations, antiinfectives for local oral treatment

Chlorhexidine Gluconate 0.12% Oral Rinse digluconate is a bisbiguanide antiseptic and disinfectant, which is bactericidal or bacteriostatic against a wide range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. The antimicrobial activity covers most of the important species occurring in the oral microflora.

Pharmacokinetic properties

Due to its cationic nature, Chlorhexidine Gluconate 0.12% Oral Rinse digluconate binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

Special precautions for disposal and other handling

Not applicable.