CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH PEPPERMINT FLAVOUR

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

Ecolab Limited

ATC code:

A01AB03

INN (International Name):

CHLORHEXIDINE GLUCONATE

Dosage:

0.2 %w/v

Pharmaceutical form:

Oromucosal Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

chlorhexidine

Authorization status:

Marketed

Authorization date:

2000-02-18

Summary of Product characteristics

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:
Macrogol glycerol hydroxysterate 0.7% w/w
For a 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 Mouthwash contains chlorhexidine.
Chlorhexidine is known to induce
hypersensitivity, including g