Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% w/v Oromucosal Solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Chlorhexidine gluconate

Dostupno od:

Ecolab Deutschland GmbH

ATC koda:

A01AB; A01AB03

INN (International ime):

Chlorhexidine gluconate

Doziranje:

0.2 percent weight/volume

Farmaceutski oblik:

Oromucosal solution

Područje terapije:

Antiinfectives and antiseptics for local oral treatment; chlorhexidine

Status autorizacije:

Not marketed

Datum autorizacije:

2000-02-18

Uputa o lijeku

CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH
Original Flavour
0.2% w/v OROMUSCAL SOLUTION
A medicated mouthwash for treatment and prevention of gum problems.
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.
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
KEEP OUT OF SIGHT AND REACH OF CHILDREN
The active ingredient is Chlorhexidine Gluconate 0.2% w/v andthe other
ingredients are ethanol,
sorbitol, macrogol glycerolhydroxystearate, flavour E2309 10 N1,
ponceau 4R E124 (redcolouring)
and purified water. See attached leaflet for further information.
MA HOLDER & MANUFACTURER
Ecolab Deutschland GmbH
Ecolab-Allee 1, D-40789
Germany
PA1843/3/1
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

Svojstava lijeka

Health Products Regulatory Authority
21 March 2023
CRN00DF5H
Page 1 of 5
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
Chlorhexidine Gluconate 0.2% w/v
Excipients with known effect: 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 Antis