Corsodyl 1% W/W Dental Gel

Document: label-leaflet MAH BRAND_PL 00079-0314 change

GSK Drawing No.: D101D091/03 Dimensions: 141 x 48 x 35

Factory: Purna

Component Carton

Date: 29th May 2014

Profile Keys:

Varnish Free Print Free Copy/Text Free Pharma Code Quiet Zone

178.25

luw ih

• You may notice a dienge 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

5 000347"070761 > TM^duuiyims.

UBiammim

Active ingredient Chlorhexidine Digluconate 1% w/w.

Other ingredients; Hydroxypropylcellulose, macrogdglycerol hydroxystearate, sc Int oil. Isopropyl alcohol and water.

h- Is; GlaxoSmithKline Consumer Healthcare, Brentford,

TW8 9GS, U.K. and GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, CrtyWest Business Campus, Dublin 24, Ireland.

The manufacturer Is: Purna Pharmaceuticals NV, Rijksweg 17,2870 Puurs, Belgium.

PL 00079/0314 PA 678/2/1

Corsodyl is a registered trade mark owned by or licensed to the GSK group of companies.

PJ Pregnancy and breast feeding

You can use Corsodyl if you are pregnant or breast feeding.

n> Do not swallow.

• Do not exceed the stated dose.

• Toothpastes can stop Corsodyl working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using Corsodyl. You can also use the gel at a different time of day.

H* Gum disease: Brush your teeth for at least one minute once or twice daily using 2 cm of gel. Continue the treatment for about one month.

• Mouth ulcers & oral thrush: Apply gel directly to the sore areas using your finger tip or a cotton bud once or twice daily for at least one minute. Continue use for 2 days after healing has occurred.

• Denture sore mouth; Smear gel lightly over the fitting surfaces of the dentures before Insertion; cleanse and soak the dentures In Corsodyl mouthwash for 15 minutes twice daily or as directed by your dentist.

• Dental surgery or tooth decay; Use as directed by your dentist If your symptoms persist, see your dentist

Corsodyl can have side effects, but not everybody gets them.

■ Stop using the gel and seek immediate medical help if you get a rash, swding of the mouth or face or have drffkiity breathing. These effects may be symptoms of a severe allergic reaction which is very rare.

• Stop using the gel and tel your dentist if you get Inflation, soreness or swelling of the mouth. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

rwiM ufa offortc man nrmr effects^not ^ ^{0,1 urtor}- You can also report side effects directly via the Yellow Card Scheme

umw sne mens mac may occur www.mhra.gov.uk/yellowcard or via HPRA Pharmacovigilance, Earisfort Terrace, IRL ■ Dublin 2;

■ Temporary staining of the tongue. This disappears when treatment is stopped. Tel:+353 1 6764971; Fax:+353 1 6762517. Website: www.hpra.ie; E-mail: medsafetyOhpra.ie.

• Temporary staining of the teeth. This can normally be removed by brushing. You can avoid staining By reporting side effects you can help provide more information on the safety of this medicine,

by not drinking tea, coffee or red wine - espedallyone hour after use, and by blushing daily with MMI,W.kJ.l.'J

toothpaste (see How to use). If toning ^a ** ^& P°^{llsh frwn} »°^ur Keep out of the roach and sight of diidren. Do not use after the 'EXP' date shown on the pack,

ean your uemures wrn oencure cieaner. q_{0 no}t store above 25°C

CORSODYL"

1 % w/w Dental Gel

chlorhexidine digluconate

The active ingredient is chlorhexidine digluconate which is an antibacterial agent that reduces the formation of dental plaque and is used to;

• Treat and prevent gun disease (gums may bleed when bnished)

• Maintain mouth hygiene

• Promote healing after dental sirgery or treatment

• Control recurring mouth ulcers

• Manage denture sore mouth and recurring oral thrush

• Prevent cavities for those at high risk of tooth decay

ummimm

□ Do not use;

• If you have ever had an allergic reaction to chlorhexidine digluconate or any of the other ingredients (see Further information).

•In children under 12 years unless recommended by a dentist.

• Anywhere other than in your mouth. Wash thoroughly if you get any in your eyes or ears.

• Immediately after brushing your teeth. See Howto use for more information.

HTake spedal care with Corsodyl

• Do not bleach fabrics that have been in contact with the gel.

9£Z

1st bar/Left

@SGS

GSK Drawing No.: D101D091/03 Dimensions: 141x43x35

Factory: Purna

Component: Carton

Date: 29th May 2014

Profile Keys:

Varnish Free Print Free Copy/Text Free Pharma Code Quiet Zone

mm itl

S£Z

®o

©o

• o

©o

••

•o

©o

•o

©o

•o

oo oo

sez

BRAILLE EXPLANATIONS AND TRANSLATIONS

| Only Braille text, will not be printed

• •••••••••• •• •• •••• lllfol

•: •: corsodyl #1 •; ;s dental gel

% w/w

The Market is fully responsible for the approval and certification of the Braille translation and content

30mm

130mm

UJLU£

7/ZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZA

93mm

CORSODYL^-

1 % w/w Dental Gel

chlorhexidine digluconate

^Tr*EATS gum PROBLEMS

50 g

—g

;

Please read the outer carton carefully before usirigtorsodyl Dental Gel.' Do not use:

Check before you use

In children under 12 years unless recommended by a dentist.

Anywhere other than in your mouth. Wash thoroughly if you get any in your eyes or ears.

How to use

• For oral use only. Do not swallow. Do not exceed the stated dose.

• Gum disease: Brush your teeth for at least one minute once or twice daily using 2 cm of gel. Continue the treatment for about one month.

• Mouth ulcers & oral thrush: Apply gel directly to the sore areas using your finger tip or a cotton bud once or twice daily for at least

g

one minute. Continue use for 2 days after healing has occurred.

Denture sore mouth: Smear gel lightly over the fitting surfaces of the dentures before insertion; cleanse and soak the dentures in CnrsocM. mouthwash focJ.5 minutesJwicejlailyiir asjbreded byyourjlentisL. _ _ _ _ _ _ _ _ _

£

E

Ln

PM

• Dental surgery or tooth decay: Use as directed by your dentist.

Stop using tne gel and tell your dentist if you get irritation, soreness or swelling of the mouth.

How to store

Keep out of the reach and sight of children. Do not use after the EXP date. Do not store above 25°C.

Further information

Active ingredient: Chlorhexidine Digluconate 1% w/w.

Other ingredients: Hydroxypropylcellulose, macrogolglycerol hydroxystearate, sodium acetate, levomenthol, peppermint oil, isopropylalcohol and water. Corsodyl is a registered trade mark owned by or licensed to the GSK group of companies. M406004/03 204400 LC195

PL 00079/0314 [pi PA 678/2/1

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, CityWest Business Campus,

Dublin 24, Ireland.

Made by: Purna Pharmaceuticals NV, Rijksweg 17,2870 Puuis, Belgium.

'///////////////////////////////////////////////////////,

J3J.U33

01H|

eu j | ja;u0D

>pea