Medine.co.uk

Corsodyl Mint Flavour 0.2%W/V Mouthwash

Document: label-leaflet MAH BRAND_PL 44673-0063 change

PARTICULARS TO APPEAR ON THE OUTER PACKAGING PEEL BACK LABEL


1. NAME OF THE MEDICINAL PRODUCT


Corsodyl® Mint Flavour 0.2% w/v Mouthwash chlorhexidine digluconate


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredient: Chlorhexidine Digluconate 0.2% w/v.


3. LIST OF EXCIPIENTS


Other ingredients: Glycerol, Macrogolglycerol Hydroxystearate, Sorbitol Liquid (NonCrystallising), Peppermint Flavour and Purifed Water.


4. PHARMACEUTICAL FORM AND CONTENTS


Mouthwash 300 ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


• Use twice a day. Fill the cap to 10 ml line. Rinse mouth thoroughly for 1 minute then spit out. • Do not swallow • Do not use more mouthwash than the label tells you to.


6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN


Keep out of the sight and reach of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


Use only if seal on cap is present and intact before opening.

Macrogolglycerol Hydroxystearate may cause skin reactions.

Check before you use:

Do not use:

•    If you have ever had an allergic reaction to chlorhexidine digluconate or any of the other ingredients (see What is Corsodyl Mint Flavour 0.2% w/v Mouthwash for?).

•    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 How to use for more information.

Take special care with Corsodyl

   Temporary staining of the teeth and tongue may occur. See Possible side effects for more information.

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

Pregnancy and breast feeding

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

•    Do not swallow and do not use more mouthwash than the label tells you to.

If your symptoms persist, see your dentist.

Possible side effects

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

•    Stop using the mouthwash and seek immediate medical help if you get a rash, swelling of the mouth or face or have difficulty breathing. These effects may be symptoms of a severe allergic reaction which is very rare. • Stop using the mouthwash and tell you dentist if you get irritation of the mouth, soreness or swelling of the inside of the cheeks. These effects should go away when treatment is stopped.

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 How to 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 mouthwash. This usually goes away with continued use. If peeling of the skin inside the mouth occurs, dilute Corsodyl with an equal amount of water.

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 in this leaflet. You can also report side effects directly via the Yellow

Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.


8. EXPIRY DATE


EXP:


9. SPECIAL STORAGE CONDITIONS


Storage and further information

Do not use after the ‘EXP’ date shown on the pack. Store below 25°C. Use within 3 months of opening.


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >


11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


MA Holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is Omega Pharma Manufacturing GmbH & Co. KG, Herrenberg, Germany.

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


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0063


13. BATCH NUMBER


BN:

14. GENERAL CLASSIFICATION FOR SUPPLY


< not applicable - GSL >

15. INSTRUCTIONS ON USE


Read the information underneath carefully before use.

ALCOHOL FREE

•    Bleeding Gums

•    Irritated Gums

•    Mouth Ulcers

TREATS GUM PROBLEMS

What is Corsodyl Mint Flavour 0.2 % w/v Mouthwash for?

The active ingredient is chlorhexidine digluconate which is an antibacterial agent that reduces the formation of dental plaque and is used to: • Treat & prevent gum disease (where gums may bleed when brushed) • Promote gum healing after dental surgery or treatment • Control mouth ulcers • Maintain mouth hygiene • Manage oral thrush and denture sore mouth

Text revised: July 2016.

How to use

•    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 mouthwash at a different time of day.

•    Use twice a day. Fill the cap to 10 ml line. Rinse mouth thoroughly for 1 minute then spit out.

•    Gum disease: A one month course (600 ml) is recommended.

•    Mouth ulcers & oral thrush: Continue to use for 2 days after healing has occurred.

•    Denture sore mouth: Clean & soak your dentures in Corsodyl for 15 minutes twice a day.

•    Dental surgery: Rinse as directed by your dentist.

16. INFORMATION IN BRAILLE


corsodyl mint Flavour #0.2% w/v mouthwash