Corsodyl Dental Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

Beecham Group PLC 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

A01AB03

INN (International Name):

CHLORHEXIDINE GLUCONATE 1 % (W/W)

Pharmaceutical form:

OROMUCOSAL GEL

Composition:

CHLORHEXIDINE GLUCONATE 1 % (W/W)

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-03-24

Patient Information leaflet

IT IS AN ANTIBACTERIAL SOLUTION WHICH INHIBITS THE
FORMATION OF DENTAL PLAQUE, & IS USED TO:
• TREAT & PREVENT GINGIVITIS (GUM DISEASE - USUAL SIGN IS GUMS THAT
BLEED WHEN BRUSHED)
• PROMOTE GUM HEALING AFTER DENTAL SURGERY • CONTROL MOUTH ULCERS
• MAINTAIN MOUTH
HYGIENE • MANAGE ORAL THRUSH & DENTURE SORE MOUTH
DO NOT USE IF PLASTIC WRAP IS MISSING OR NOT INTACT
Use twice daily. Fill cap to 10 ml line. Rinse mouth thoroughly for 1
minute then spit out.
GUM DISEASE: One month course (600 ml) is recommended.
MOUTH ULCERS & ORAL THRUSH: Continue to use for 2 days after healing
has occurred.
DENTURE SORE MOUTH: Dentures should be cleansed & soaked in Corsodyl
for 15 mins twice daily.
DENTAL SURGERY: Rinse as directed by your dentist.
if symptoms persist.
0.2% w/v chlorhexidine digluconate. Also contains ethanol 7% v/v,
macrogolglycerol hydroxystearate, sorbitol, peppermint oil, water.
Store below 25ºC.
KEEP SAFELY AWAY FROM CHILDREN
Do not use after the "use by end of" date shown on the pack.
WHAT IS CORSODYL FOR?
HOW TO USE
CONTAINS
GLAXOSMITHKLINE CONSUMER HEALTHCARE, BRENTFORD, TW8 9GS, U.K.
CORSODYL is a registered trade mark of the GlaxoSmithKline group of
companies.
Text revised: February 2004.
Made by SmithKline Beecham
Consumer Healthcare,
Maidenhead, SL6 4BL, U.K.
CONSULT YOUR DENTIST
WHEN USING
DO NOT USE
PLEASE READ BEFORE USING
if you are sensitive to chlorhexidine or any of the other listed
ingredients.
• TOOTHPASTES MAY STOP CORSODYL WORKING PROPERLY IF USED IMMEDIATELY
AFTERWARDS.
TO PREVENT THIS, USE TOOTHPASTE AT A DIFFERENT TIME OF DAY, OR USE
TOOTHPASTE FIRST, RINSE
THOROUGHLY WITH WATER & WAIT 5 MINUTES BEFORE USING CORSODYL.
• WHEN USING CORSODYL, DISCOLOURATION OF THE TONGUE & TEETH MAY
OCCUR WHICH IS NOT
PERMANENT. TONGUE STAINING DISAPPEARS AFTER TREATMENT STOPS & TOOTH
DISCOLOURATION IS
NORMALLY REMOVED BY BRUSHING. STAINING CAN GENERALLY BE AVOIDED BY:
1) NOT DRINKING TEA, COFFEE OR RED WINE - ESPECIALLY FOR THE FIRST
HOUR AFTER USE
2) BRUSHING DAILY WITH TOOTHPASTE BEFORE US

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Corsodyl Dental Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 1.0% w/w
(equivalent to Chlorhexidine Digluconate Solution Ph Eur 5.325 % w/w)
3. PHARMACEUTICAL FORM
Oromucosal gel.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Inhibition of formation of dental plaque.
As an aid in the treatment and prevention of gingivitis.
As an aid to maintaining oral hygiene.
Also for use in a post-peridontal surgery or treatment* regimen to
promote gingival healing.
*NB: Use as part of a post-periodontal treatment regimen has only been
adequately studied over the
short term and following standard root surface instrumentation.
It is useful in the management of recurrent aphthous ulceration.
It is useful in the management of recurrent oral candidal infections.
As an aid in the prevention of dental caries in high-caries-risk
patients (for example xerostomia
sufferers), when used in a regimen as an adjunct to fluoride.
Page 2 of 6
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Brush the teeth thoroughly with one inch of gel on a moistened
toothbrush, once or twice daily for
about one minute.
For the treatment of gingivitis, a course of about one month is
advisable.
When used for the management of aphthous ulceration and oral candidal
infections an alternative
method of delivery may be required which facilitates application of
the gel to affected areas. This
should be used once or twice daily for about one minute. The length of
treatment time should be
decided on the basis of clinical response.
When used as par of a regimen to prevent dental caries the gel should
be applied for 5 minutes
nightly for 14 days in a close fitting way. This treatment should be
repeated every 3-4 months or as
directed by the dentist. When used as part of a regimen to prevent
dental caries of remaining teeth
in dental wearers the gel may be applied to the fitting surfaces of
the denture before insertion.
During the treatment of denture stomatitis t