4.1. Therapeutic indications

Aids prevention of dental plaque formation. Aids the treatment and prevention of gingivitis. For the maintenance of oral hygiene. Promotes gingival healing following periodontal surgery. Management of recurrent oral ulceration. For the treatment of denture stomatitis and oral thrush.

4.2. Posology and method of administration

For oromucosal use.

Adults, the elderly and children: To be used as required up to twice daily. Rinse the mouth thoroughly for about 1 minute with 10ml. The mouthwash should be expelled from the mouth after rinsing.

Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute. The mouthwash should be expelled from the mouth after rinsing.

Treatment of gingivitis: A course of one month is recommended.

Treatment of denture stomatitis: Soak the denture(s) in solution for 15 minutes twice daily.

Treatment of oral ulceration and oral thrush: Treatment should be continued for 48 hours after clinical resolution.

4.3. Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4. Special warnings and precautions for use

For oral use only. Keep away from the eyes and ears. If the solution comes into contact with the eyes, rinse well with water. Keep out of the reach and sight of children. Do not swallow. If symptoms persist, stop using and consult your doctor or dentist.

Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Chlorhexidine Mouthwash should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).

4.5. Interaction with other medicinal products and other forms of interaction

Chlorhexidine digluconate is incompatible with anionic agents which are usually present in conventional dentrifices. These should therefore be used before the mouthwash. Rinse the mouth thoroughly with water before using the mouthwash.

4.6. Fertility, pregnancy and lactation

No harmful effects in human pregnancy or during lactation have been reported. Nevertheless like all medicines, care should be exercised and the mouthwash should only be used on the advice of a doctor or dentist.

4.7. Effects on ability to drive and use machines

No or negligible influence.

4.8. 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 (see sections 4.3 and 4.4).

Nervous System Disorders

Common: Oral paraesthesia/hypoaesthesia

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.

4.9. Overdose

Chlorhexidine 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.