PL 16431/0122 Patient Information Leaflet

CHLORHEXIDINE GLUCONATE MOUTHSPRAY

Chlorhexidine Gluconate

BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY

This leaflet contains a summary of the information about your medicine, Chlorhexidine Gluconate Mouthspray.

YOUR MEDICINE

Chlorhexidine Gluconate Mouthspray is a mint flavoured solution containing Chlorhexidine gluconate 0.2% w/v as active ingredient.

Chlorhexidine Gluconate Mouthspray comes in a pump-action spray bottle containing 60ml of solution.

The active ingredient of this medicine, chlorhexidine gluconate, is an antimicrobial, which acts to kill the harmful bacteria present on the surface of your teeth and gums.

Chlorhexidine Gluconate Mouthspray is used to help stop dental plaque from forming. It helps to treat and prevent gingivitis (gum disease), and to maintain oral hygiene. It is particularly useful when the teeth can’t be brushed properly, for example after surgery in the mouth or for those with physical handicaps.

Occasionally medicines containing chlorhexidine can cause an itchy/red skin reaction. Very rarely a general allergic reaction to chlorhexidine can occur (rash, itching, sometimes shortness of breath). If you experience these symptoms, stop using the medicine and see your doctor or dentist.

The surface of your tongue may become discoloured. This disappears when you stop taking the medicine.

Your teeth and/or fillings may become discoloured. This stain is not permanent and can usually be prevented if you can brush with conventional toothpaste before using the spray. In some cases though, you may have to have a scale and polish from your dentist to remove the stain completely. Tooth-coloured fillings which are in poor condition may not be adequately cleaned even by the dentist and may need replacing.

When it is not possible to brush the teeth properly, for example with a brace fixed to the teeth, then scaling and polishing may be required when the underlying condition has been resolved.

You may notice a change in the way things taste, or even a burning sensation on the tongue when you first use the spray. This will usually go away as you continue with your treatment. If notice any shedding of the surface layer of skin inside your mouth (peeling) then stop taking the medicine.

Occasionally, swelling of the salivary glands during the use of chlorhexidine mouthwash has been reported. In all cases this has been returned to normal when the treatment was stopped.

Tell your doctor, dentist or pharmacist if you notice any other unwanted effects not mentioned above.

Do not take this medicine if you know you are allergic to any of the ingredients.

The medicine is only for use in the mouth. Do not swallow. Expel from mouth after each use. Keep it away from the eyes and ears. If any spray does come into contact with the eyes, wash it out well with water.

This medicine can be stopped from working properly by the ingredients of some toothpastes. Therefore, brushing with toothpaste should be done first and the mouth rinsed out well with water before using Chlorhexidine Gluconate Mouthspray. Alternatively you can use the spray at a different time of day.

As with all medicines, if you are pregnant, ask your doctor before using Chlorhexidine Gluconate Mouthspray.

When using the spray for the first time, remove the dustcap from the top of the bottle and replace with the nozzle actuator, which is supplied separately inside the carton.

The spray should be used twice a day (in the morning and in the evening), using up to 12 shots of the spray at each time. (Each shot from the spray gives about 0.14ml of solution).

Direct the spray inside your mouth onto surfaces of the teeth and gums.

For gum disease, it is recommended that you continue to use the medicine for about one month. Your doctor, dentist or pharmacist may advise you to use it for a longer or shorter period of time, depending on your particular needs.

Problems of overdosage with Chlorhexidine Gluconate Mouthspray should not occur as chlorhexidine is poorly absorbed into the body. However if a large volume of the solution is swallowed accidentally then contact your doctor who can then decide whether washing out the stomach is needed.

The expiry date of this product is printed on the carton and the bottle label. Do not use the product after this date.

Store the product below 25°C.

Active Ingredient

Chlorhexidine Gluconate BP    0.20%w/v

Inactive Ingredients

Peppermint Flavour E1640-1-N1(HSE)

Ethanol (BP)

Sorbitol (BP)

Cremophor RH60 (HSE)

Purified water (BP)

The product licence for Chlorhexidine Gluconate Mouthspray is held by: Ayrton Saunders Ltd.,

9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU

PL 16431/0122

The product is manufactured by: Pharmaserve (North West) Ltd.

9 Arkwright Road,

Astmoor Industrial Estate, Runcorn, Cheshire.

WA7 1NU

This leaflet was last revised October 2010.