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Chlorhexidine gluconate antiseptic mouthwash original flavour

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What Chlorhexidine Gluconate Antiseptic Mouthwash is and what it is used for

Chlorhexidine Gluconate Antiseptic Mouthwash (chlorhexidine gluconate 0.2% w/v) is an antimicrobial solution which means it kills harmful bacteria present on your teeth and gums.

•    It helps to stop dental plaque from forming and to maintain good oral hygiene.

•    It helps to treat and prevent gingivitis (gum disease).

•    It manages mouth ulcers, oral thrush and denture sore mouth.

•    It promotes gum healing following oral surgery.

Before you use Chlorhexidine Gluconate Antiseptic Mouthwash Do not use:

•    Do not use Chlorhexidine Gluconate Antiseptic Mouthwash if you are allergic to any of the ingredients (see front page for the ingredients).

Take special care:

•    For oral use. Do not swallow.

•    Keep away from the eyes and ears. If the mouthwash accidentally comes into contact with your eyes, rinse out well with clean water immediately.

•    Brushing teeth with some toothpastes can stop some of the ingredients of Chlorhexidine Gluconate Antiseptic Mouthwash from working. Brushing with toothpaste should be done first and the mouth rinsed out well with water before using the mouthwash, or the mouthwash can be used at a different time of the day.

Pregnancy and breast-feeding: As with all medicines, if you are pregnant, thinking

of becoming pregnant or breast-feeding, ask your doctor before using the mouthwash.

Important Information about some of the Ingredients: Ponceau 4R may cause

allergic reactions. Macrogol glycerol hydroxystearate may cause skin reactions.

Possible side effects

•    Chlorhexidine can very rarely cause hypersensitivity, including anaphylactic shock (throat or lip swelling, low blood pressure), and allergic reactions (e.g. dermatitis, itching, redness, eczema, rash, hives, skin irritation, blisters). If any of these reactions occur, stop using the product and seek medical attention immediately.

•    Occasionally this mouthwash can cause a skin reaction and very rarely may cause swelling of the salivary glands. (The swelling will disappear when treatment is discontinued).

•    When using this mouthwash, the tongue, teeth or fillings may become discoloured. This disappears when you stop using the medicine. This staining is not permanent and can be removed by brushing or in extreme cases can be removed by a simple scale and polish from your dentist or hygienist. If discolouration of dentures occurs clean with a conventional dental cleaner.

•    Patients should avoid tannin containing foods or drinks (such as tea, coffee and wine) for at least 1 hour after rinsing to avoid dental staining.

•    Chemical burns have been observed (very rarely) following the application of chlorhexidine to the skin of new born babies / infants.

•    You may notice a change in the way things taste or even a burning sensation when using mouthwash. This usually goes away with continued use.

•    If you notice any peeling of the surface layer of skin in your mouth, dilute the mouthwash with an equal amount of water, as it may be more appropriate than stopping altogether.

Reporting of side effects

If you get any side effects, talk to your pharmacist; doctor or dentist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below. United Kingdom: Yellow Card Scheme, Website www.mhra.gov.uk/yellowcard Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie Email medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Chlorhexidine Gluconate Antiseptic Mouthwash

Do not store above 25°C.

Store in the original container in order to protect from light.

Do not use the product after the expiry date overprinted on this label/leaflet.

Date of revision May 2015

Before using this mouthwash please peel back the label and read all the information carefully

If you have any questions please discuss them with your pharmacist, doctor or dentist before use.

How to use this mouthwash

•    Use as required, up to twice daily.

•    Fill the cap to the 10ml line. Rinse the mouth thoroughly for 1 minute.

•    Do not swallow the mouthwash.

Gingivitis (gum disease): A one month course is usually recommended (2 bottles).

Mouth Ulcers and Oral Thrush: Continue to use for 2 days after healing has occurred.

Denture Sore Mouth: Dentures should be cleaned and soaked in mouthwash for 15 minutes, morning and evening.

Before dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute.

If symptoms persist please speak to your pharmacist, doctor or dentist.

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KEEP OUT OF SIGHT AND REACH OF CHILDREN

The active ingredient is Chlorhexidine Gluconate 0.2% w/v and the other ingredients are ethanol, sorbitol, macrogol glycerol hydroxystearate, flavour E2309 10 N1, ponceau 4R E124 (red colouring) and purified water. See attached leaflet for further information.

AL

0.2% w/v OROMUCOSAL SOLUTION

A medicated mouthwash for treatment and prevention of gum problems

300ml

Marketing Authorisation Holder and Manufacturer

Ecolab Ltd, Lotherton Way, Garforth, Leeds LS25 2JY, England Tel: +44 (0)113 232 0066 PL 04509/0009 PA 1110/11/1 3037080

3037080F/08APR15/GB