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COLGATE PRO GUM HEALTH 0.2% ANTISEPTIC MOUTHWASH

Active substance: CHLORHEXIDINE DIGLUCONATE

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0.2
ANTISEPTIC MOUTHWASH
CHLORHEXIDINE DIGLUCONATE

Note: The name of this medicinal product is Colgate Pro
Gum Health 0.2% Antiseptic Mouthwash but will be
referred to as Colgate Pro Gum Health mouthwash
throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine,
because it contains important information for you.
This medicine is available without prescription. However, you still need to
use Colgate Pro Gum Health mouthwash carefully to get the best results
from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist or dentist if you need more information or advice.
- f you get any side effects, talk to your doctor, dentist, or pharmacist.
I
This includes any possible side effects not listed in this leaflet.
-  ou must talk to a doctor, dentist, or pharmacist if you do not feel better
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or if you feel worse after 7 days.




In this leaflet:
1.  hat Colgate Pro Gum Health mouthwash is and what it is
W
used for
2.  hat you need to know before you use Colgate Pro Gum Health
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mouthwash
3. How to use Colgate Pro Gum Health mouthwash
4. Possible side effects
5. How to store Colgate Pro Gum Health mouthwash
6. Contents of the pack and other information
1. WHAT COLGATE PRO GUM HEALTH mouthwash IS AND

WHAT IT IS USED FOR


Colgate Pro Gum Health mouthwash is an antiseptic which temporarily
reduces the number of germs in the mouth (thereby inhibiting the
formation of dental plaque).
Colgate Pro Gum Health mouthwash is used for adults and children over
the age of 6
• or the short-term supportive treatment of inflammation of gums and
f
mucous membrane in the mouth.
•  efore, during, or after courses of treatment for gums and supporting
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structures of the teeth and to prevent infections of surgical wounds.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLGATE

PRO GUM HEALTH mouthwash


Do not use Colgate Pro Gum Health mouthwash
If you are allergic (hypersensitive) to chlorhexidine digluconate or any of
the other ingredients of Colgate Pro Gum Health mouthwash (listed in
section 6). People that are unable to control their swallowing effectively
must not use a mouth rinse.
Take special care with Colgate Pro Gum Health mouthwash
For rinsing the mouth only - keep out of the eyes and ears, or other
tissues except the inside of your mouth. In case of contact with eyes, rinse
immediately with water and contact your doctor immediately.
Colgate Pro Gum Health mouthwash should not be used, if you have
ulcers or peeling in the oral cavity.
Continuous rinsing of your mouth with Colgate Pro Gum Health
mouthwash instead of brushing your teeth may exacerbate bleeding of the
gums.
Do not use Colgate Pro Gum Health mouthwash for longer than 7 days
at a time unless your doctor or dentist advises a longer treatment. A
continuous usage could increase the risk of bacterial or fungal infections.

Chlorhexidine digluconate, the active substance in Colgate Pro Gum
Health mouthwash, may in rare cases cause severe allergic reactions,
leading to a drop in blood pressure and even to unconsciousness. Early
symptoms of a severe allergic reaction may be skin rash or asthma. If you
notice these symptoms, stop using Colgate Pro Gum Health mouthwash
and contact your doctor as soon as possible (see under section 4:
“Possible side effects”).
Colgate Pro Gum Health mouthwash can cause staining, if spilt on
clothing.
Other medicines and Colgate Pro Gum Health mouthwash
Tell your doctor, dentist, or pharmacist if you are taking, have recently
taken, or might take any other medicines, including medicines obtained
without a prescription.
The effectiveness of Colgate Pro Gum Health mouthwash may be affected
by some toothpaste ingredients. Therefore, ideally use Colgate Pro Gum
Health mouthwash at a separate time to toothbrushing. If you use Colgate
Pro Gum Health mouthwash just after brushing rinse thoroughly your
mouth with water before rinsing with Colgate Pro Gum Health mouthwash.
Colgate Pro Gum Health mouthwash with food and drink
Do not consume sugar-containing food or drinks within an hour of using
Colgate Pro Gum Health mouthwash.
Pregnancy and breast-feeding
There is limited experience with the use of Colgate Pro Gum Health
mouthwash in pregnant women. Also, it is not known, whether
chlorhexidine is present in breast milk. Therefore, you should use Colgate
Pro Gum Health mouthwash with caution. If you are pregnant or breastfeeding, ask your doctor, dentist, or pharmacist for advice before using
Colgate Pro Gum Health mouthwash as for any medicine.

Driving and using machines
It is not expected that using Colgate Pro Gum Health mouthwash will
affect your ability to drive and operate machinery.

Important information about some of the ingredients of Colgate
Pro Gum Health mouthwash
Colgate Pro Gum Health mouthwash contains macrogol glycerol
hydroxystearate. This substance may cause skin reactions.
3. HOW TO USE COLGATE PRO GUM HEALTH mouthwash
For rinsing the mouth only. Do not swallow.
Always use Colgate Pro Gum Health mouthwash exactly as described in
this leaflet or as your doctor or dentist has advised you. You should check
with your doctor, dentist, or pharmacist if you are not sure about the correct
use of Colgate Pro Gum Health mouthwash. Colgate Pro Gum Health
mouthwash is for the use of adults and children over the age of 6 only.

Use Colgate Pro Gum Health mouthwash twice a day, ideally at a
different time to brushing your teeth:
-  inse your mouth with 10 ml (1 cap) of Colgate Pro Gum Health
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mouthwash for one minute and spit out.
If you use Colgate Pro Gum Health mouthwash just after brushing, rinse
your mouth thoroughly with water before rinsing with Colgate Pro Gum
Health mouthwash.
Colgate Pro Gum Health mouthwash is ready for use and should not be
diluted. The screw-cap on the bottle contains a measuring device to
measure a 10 ml dose.
Duration of course of treatment
Colgate Pro Gum Health mouthwash would normally not be used for
longer than 7 days at a time. It may only be used over a longer period if
advised by your doctor or dentist.

Children over the age of 6 and the elderly
There are no special dosage recommendations for either elderly patients
or children over the age of 6. The normal adult dose is appropriate
unless otherwise recommended by your doctor or dentist.

If you use more Colgate Pro Gum Health mouthwash than you
should
Cases of overdosing when using Colgate Pro Gum Health mouthwash
have not been reported. Accidentally swallowed solution is only poorly
absorbed by the gut. If you swallowed larger amounts of Colgate Pro
Gum Health mouthwash, tell your doctor or dentist.

If you forget to use Colgate Pro Gum Health mouthwash
Do not use a double dose to make up for a forgotten dose. Continue
treatment as usual according to the instructions.
If you have any further questions on the use of this product, ask your
doctor, dentist, or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Colgate Pro Gum Health mouthwash can cause side effects,
although not everybody gets them. Below is a list of known side effects
which patients have experienced while using chlorhexidine digluconate:
Rare side effects (seen in at least 1 in 10,000 patients, but in less than 1
in 1,000 patients):
- anaphylactic (allergic) reactions with symptoms such as:
• constriction of the airways (making it difficult to breathe)
• general breathing problems
• swelling around the eyes
• low blood pressure
• shock
- allergic reactions after localised use of chlorhexidine
- hypersensitivity reactions
- rash
Very rare side effects (seen in less than 1 in 10,000 patients) or side
effects, for which it is not known how common they are (because it cannot
be estimated from the data available):
- permanent damage to the cornea when the solution gets into the eye
Should you suffer from anaphylactic or allergic reactions please contact
your doctor immediately.
In case of contact with eyes, rinse immediately with water and contact
your doctor immediately.
Other side effects in order of frequency:
Very common side effects (seen in at least 1 in 10 patients):
-  iscolouration of the tongue and staining of teeth (hard tooth substance,
d
tooth coloured dental restorations)
In most cases the staining will be temporary during usage of Colgate Pro
Gum Health mouthwash. In some cases if staining of the teeth persists, you
may need a professional polish of your teeth by your dentist or hygienist.

If you notice any of these side effects, or if you notice any other side
effects not listed in this leaflet, please tell your doctor, dentist, or
pharmacist.
5. HOW TO STORE COLGATE PRO GUM HEALTH mouthwash

Keep Colgate Pro Gum Health mouthwash out of sight and reach of
children.
Do not use Colgate Pro Gum Health mouthwash after the expiry date
which is stated on the carton and the bottle after “EXP”. The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The product should be discarded 4 weeks after first opening.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist about how to throw away any medicines you no
longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Colgate Pro Gum Health mouthwash contains
-  he active substance is chlorhexidine digluconate. 1 ml contains 2 mg
T
chlorhexidine digluconate. One dose of 10 ml contains 20 mg
chlorhexidine digluconate.
-  ther ingredients are sorbitol, liquid (non-crystallising), glycerol,
O
macrogol glycerol hydroxystearate, citric acid monohydrate (for
pH-adjustment), peppermint oil, Patent blue V (E 131) and purified
water.
What Colgate Pro Gum Health mouthwash looks like and
contents of the pack
Colgate Pro Gum Health mouthwash is a clear blue solution.
Package size: Bottle containing 300 ml.

Marketing Authorisation Holder
Colgate-Palmolive (UK) Ltd.
Guildford Business Park
Middleton Road, Guildford
Surrey, GU2 8JZ
United Kingdom
Manufacturer
Colgate-Palmolive (UK) Ltd.
The Dental Health Unit,
Williams House, Lloyd Street North,
Manchester Science Park,
Manchester, M15 6SE
United Kingdom
On request, this leaflet is available in formats suitable for the blind and
partially-sighted.

This leaflet was last revised in October 2012.

Other very common side effects:
- change in taste in the mouth
- a prickling sensation
- irritation of the tongue
- irritation of the mucosa in the mouth
These effects will disappear once you stop using Colgate Pro Gum Health
mouthwash.
Common side effects (seen in at least 1 in 100 patients, but in less than 1
in 10 patients):
- formation of hard deposits on the teeth above the gum line
- peeling of the mucous membrane in the mouth
- inflammation of the mouth
Uncommon side effects (seen in at least 1 in 1,000 patients, but in less
than 1 in 100 patients):
- disorder of mucous membrane in the mouth
Very rare side effects (seen in less than 1 in 10,000 patients) or side
effects, for which it is not known how common they are (because it cannot
be estimated from the data currently available):
-  welling of the salivary gland near the ear (which reduces when the
s
treatment has stopped)

10119999

50900-01 - 25 OCT. 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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