Chlorhexidine gluconate 0.2% mouthwash original

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorhexidine gluconate

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

A01AB03

INN (International Name):

Chlorhexidine gluconate

Dosage:

2mg/1ml

Pharmaceutical form:

Mouthwash

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030400

Patient Information leaflet

PEEL HERE
ANTISEPTIC
CHLORHEXIDINE
GLUCONATE
0.2% W/V OROMUCOSAL SOLUTION
300ML
A MEDICATED MOUTHWASH FOR TREATMENT
AND PREVENTION OF GUM PROBLEMS
O
R
I
G
I
N
A
L
F
L
A
V
O
U
R
KEEP OUT OF SIGHT AND REACH OF CHILDREN
MARKETING AUTHORISATION HOLDER
AND MANUFACTURER
Ecolab Ltd, Lotherton Way, Garforth,
Leeds LS25 2JY, England
Tel: [phone]
3037080
3037080F/08APR15/GB
4 028163 037080
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.
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.
Chlorhexidine gluconate
antiseptic mouthwash
original flavour
Chlorhexidine gluconate
antiseptic mouthwash
original flavour
PL 04509/0009
ANTISEPTIC
CHLORHEXIDINE
GLUCONATE
0.2% W/V OROMUCOSAL SOLUTION
300ML
A MEDICATED MOUTHWASH FOR TREATMENT
AND PREVENTION OF GUM PROBLEMS
O
R
I
G
I
N
A
L
F
L
A
V
O
U
R
KEEP OUT OF SIGHT AND REACH OF CHILDREN
MARKETING AUTHORISATION HOLDER
AND MANUFACTURER
Ecolab Ltd, Lotherton Way, Garforth,
Leeds LS25 2JY, England
Tel: [phone]
3037080
3037080F/08APR15/GB
Before using this mouthwash please peel back the
label and read all the information carefully
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% W/V
Oromucosal Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients:
Ponceau 4R 0.001%w/w
Macrogol glycerol hydroxystearate 0.7 % w/w
For full list of excipients see Section 6.1
3.
PHARMACEUTICAL FORM
Oromucosal Solution
A clear pink solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial
solution which
inhibits the formation of dental plaque. It is indicated as an aid to
the treatment and
prevention of gingivitis and in the maintenance of oral hygiene,
particularly in
situations where toothbrushing cannot be adequately employed (eg
following oral
surgery or in physically handicapped patients). It is used to promote
gingival
healing following periodontal surgery, to manage recurrent oral
ulceration.
Additionally it is useful in the treatment of denture stomatitis and
thrush.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Children, adults and the elderly.
Chlorhexidine Gluconate Antiseptic Mouthwash should be used as
required up to
twice daily.
Rinse the mouth thoroughly for about 1 minute with 10 ml. Prior to
dental
surgery, the patient should be instructed to rinse the mouth with 10
ml for 1
minute. In the treatment of gingivitis a course of about one month is
recommended (ie two bottles). For denture stomatitis cleanse and soak
the
denture in solution for 15 minutes twice daily. In the case of
aphthous ulceration
and oral candidal infections, 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
Chlorhexidine Gluconate Antiseptic Mouthwash contains chlorhexidine.
Chlorhexidine is
known to induce hypersensitivity, including generalised allergic
re