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

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Chlorhexidine gluconate

Boleh didapati daripada:

Ecolab Deutschland GmbH

Kod ATC:

A01AB; A01AB03

INN (Nama Antarabangsa):

Chlorhexidine gluconate

Dos:

0.2 percent weight/volume

Borang farmaseutikal:

Oromucosal solution

Kawasan terapeutik:

Antiinfectives and antiseptics for local oral treatment; chlorhexidine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2000-02-18

Risalah maklumat

4
PACKAGE LEAFLET
5
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:
Macrogol glycerol hydroxystearate may cause skin reactions.
POSSIBLE SIDE EFFECTS
•
CHLORHEXIDINE CAN VERY RARELY CAUSE HYPSERSENSITIVITY, 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

Ciri produk

Health Products Regulatory Authority
31 October 2023
CRN00DXMW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate Antiseptic Mouthwash Peppermint Flavour 0.2%
w/v Oromucosal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 0.2% w/v
Excipients with known effect:
Macrogol glycerol hydroxystearate 0.7 % w/w
For full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Oromucosal Solution.
A clear colourless 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 Mouth