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Chorhexidine Gluconate Antiseptic Mouthwash Peppermint Flavour 0.2% W/V Oromucosal Solution

Document: label-leaflet MAH GENERIC_PL 04509-0010 change

■ ANTISEPTIC


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.

CHLORHEXIDINE

GLUCONATE

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0.2% w/v OROMUCOSAL SOLUTION CHLORHEXIDINE GLUCONATE A medicated mouthwash for treatment and prevention of gum problems 300ml

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

The active ingredient is Chlorhexidine Gluconate 0.2% w/v and the other ingredients are ethanol, sorbitol, macrogol glycerol hydroxystearate, flavour E1640 10 N1 and purified water. See attached leaflet for further information.

Marketing Authorisation Holder and Manufacturer

Ecolab Ltd, Lotherton Way, Garforth, Leeds LS25 2JY, England Tel: +44 (0)113 232 0066

PL 04509/0010 PA 1110/11/2 3037100 438777 3037100F/01MAR13/GB

ECOLAB*

Do not remove this label-leaflet from the container.

□ APPROVED

dl APPROVED AFTER CORRECTIONS

COUNTRY _

DATE/NAME _

print-out not in original size !

Chlorhexidine Gluconate Antiseptic Mouthwash Peppermint Flavour / GB

300 ml / Front - Leaflet Front 348 x 65 mm

Schaab / 01.03.2013    PANTONE 3405 PANTONE 295 Black Braille Letter Die Cut

Page 4-168 mm

3037100F-2.pdf


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A medicated mouthwash for treatment prevention of «jum prob'ems

300ml


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.

CHLORHEXIDINE

GLUCONATE

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

The active ingredient is Chlorhexidine Gluconate 0.2% w/v and the other ingredients are ethanol, sorbitol, macrogol glycerol hydroxystearate, flavour E1640 10 N1 and purified water. See attached leaflet for further information.

How to use this mouthwash


0 2% w/v OROMUCOSAL SOL' IT'ON CHLORHEX'OINF GLUCONATE



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•    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^rl Y^rush^Contftue t(Rise 2 da^s

after healing has occurred# • •    • •• ••    •

•    • •

Denture Sore Mouth: Dentures should be cleaned and soaked in mouthwash for^50iinut|£, mqgning r-id aveniijgg.^

Before dental surgery: Rin^ttft ftoiiffh thoftughly vffth*

10ml for 1 minute. •    •    •    •

If symptoms persistjDl#as#spes#t#y<0it^>h#maofrt, do ':c . or dentist,    ^    ^ ^    ^    • • •

• • • • •

Marketing Authorisation Holder and Manufacturer

ftx^fcAtd, Lfth#rtc^ Way, G#rf<#th, Leeds LSm 2JY«England • •

Tel:+4^(0)11^232 0066 #

PL 04509/0010 PA 1110/11 /2 $)37100 t3#77 30371 ®F/01«/W13/GB

ECOLAB

l%Wot remove this label-leaflet A)m the container.

PEEL HERE

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).

•    Do not use on new born babies/infants.


Take special care:

•    For oral use only.

•    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:

Macrogol glycerol hydroxystearate may cause skin reactions.


Possible side effects

•    Chlorhexidine can sometimes cause allergic reactions e.g. itching, shortness of breath, anaphylactic shock (throat, lip swelling, low blood pressure) but this is extremely rare. If an allergic reaction occurs, 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.


•    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.

•    If you are concerned about these or any other unwanted effects, stop using Chlorhexidine Gluconate Antiseptic Mouthwash and consult your pharmacist, doctor or dentist.

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.


This label-leaflet was approved January 2013.