Corsodyl 1% w/w Dental Gel

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Chlorhexidine digluconate

Доступна с:

Haleon Ireland Limited

код АТС:

A01AB; A01AB03

ИНН (Международная Имя):

Chlorhexidine digluconate

дозировка:

1 percent weight/weight

Фармацевтическая форма:

Dental gel

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

Antiinfectives and antiseptics for local oral treatment; chlorhexidine

Статус Авторизация:

Marketed

Дата Авторизация:

1975-04-29

тонкая брошюра

Corsodyl

1% W/W DENTAL GEL
CHLORHEXIDINE DIGLUCONATE
50g
Possible side effects
Corsodyl can have side effects, but not everybody gets them.
• STOP USING the gel and SEEK IMMEDIATE MEDICAL HELP if you get a
RASH, SWELLING OF THE LIPS,
TONGUE, THROAT OR FACE or HAVE DIFFICULTY BREATHING. These effects may
be symptoms of a severe
allergic reaction which is very rare.
• STOP USING the gel and TELL YOUR DENTIST if you get IRRITATION,
SORENESS or SWELLING OF THE MOUTH.
OTHER SIDE EFFECTS that may occur:
• Temporary STAINING OF THE TONGUE. This disappears when treatment
is stopped.
• Temporary STAINING OF THE TEETH. This can normally be removed by
brushing. You can avoid
staining by not drinking tea, coffee or red wine – especially one
hour after use, and by
brushing daily with toothpaste (see Check before you use). If staining
continues it can be
removed with a scale & polish from your dentist or hygienist. You can
clean your dentures
with denture cleaner.
• You may notice A CHANGE OF TASTE OR BURNING SENSATION when you
first use the gel.
This usually goes away with continued use.
IF YOU DO GET ANY SIDE EFFECTS, even those not mentioned above, TELL
YOUR DOCTOR, DENTIST OR
PHARMACIST.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed on this carton. You can also report side
effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or
Apple App Store, or via HPRA Pharmacovigilance, Website: www.hpra.ie
.
By reporting side effects you can help provide more information on the
safety of this medicine.
How to store
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Use within 1 month of
opening. Do not use after the
‘EXP’ date shown on the pack.
Do not store above 25°C.
WHAT IS CORSODYL DENTAL GEL FOR?
The active ingredient is chlorhexidine digluconate which is an
antibacterial
agent that reduces the formation of dental plaque and is used to:

Характеристики продукта

Health Products Regulatory Authority
12 July 2023
CRN00DM3P
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Corsodyl 1% w/w Dental Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine digluconate 1% w/w (as Chlorhexidine digluconate
Solution).
Excipients: Contains Macrogolglycerol Hydroxystearate 1% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dental Gel
A clear or faintly opalescent, transparent, colourless or slightly
coloured gel with an odour of peppermint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the inhibition of the formation of dental plaque.
As an aid in the treatment and prevention of gingivitis.
As an aid to maintaining oral hygiene.
For use in a post-periodontal surgery or treatment regimen to promote
gingival healing.
It is useful in the management of recurrent aphthous ulceration.
It is useful in the management of recurrent oral candidal infections.
It may also be used as part of a preventative programme to help reduce
caries activity.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Brush the teeth thoroughly with one inch of gel on a moistened
toothbrush, once or twice daily for about one minute. Spit out
any excess. Do not rinse after applying gel.
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 the 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.
During the treatment of denture stomatitis thoroughly brush all over
the dentures with 2.5 cm of gel on a moistened
toothbrush, once or twice daily for about one minute.
For the prevention of caries, 1-2 inches of ‘Corsodyl’ Dental Gel
should be applied to the teeth daily, preferably by close-fitting
tray, remaining in contact with the teeth for 5 minutes. The