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ANBESOL ADULT STRENGTH GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / CHLOROCRESOL / LIDOCAINE HYDROCHLORIDE

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Artwork Information
Product Title:

Anbesol Adult Gel

Date:

16-12-16

Label Number:

16-303

Fonts Used:

Arial, Arial Bold

Font size (min):

7pt

IVersion 2

Product Size:

140mm x 150mm

Colours Used:

BLACK,

Artwork by:

Keylines, Guides, Dimensions and Cutter guide are NOT to be printed.

b ALLIAN Ct
I

ANBESOL®ADULT STRENGTH GEL
Lidocaine Hydrochloride, Chlorocresol
and Cetytpyridinium Chloride

PATIENT INFORMATION LEAFLET
IRead all of1hls leaflet carefully before using 1hls medicine as It
contains important information for you.
•• Keep this leaftel You may wish to read It again.
I Ask your pharmacist if you need more infonnation or advice.
• If you get any side effacts, talk to your doctor or pharmacist.
I This includes any possible side elfects not listed in this leaflet.
What is in this leaflet
1. What Anbelol Adult strength Gel is 111d whit it is used for
2. What you need to know before you use Anbesol Adull
strength Gal
3. How to un Anbesol Adult Stnmgth Gal
4. Pouibla side affacts
5. How to store Anbasol Adult Sllllngth Gal
II. Contents of pack and othar Information

111. What Anbasol Adult Slrwngth Gal Is and what It Is usad for I
Anbesol Adult strength Gel contains 2.0%w/w of
lidocaine hydrochloride, 0.1 %w/w of chlorocresol and
I0.02%w/w of cetytpyridinium chloride.
Lidocaine hydrochloride is a local anaesthetic which
worb by stopping the sensation of pain. Chloroaasol and
lcetylpyridinium chloride kill bacteria.
Anbesol Adult strength Gal is used for temporary relief of
pain caused by recurrent mouth ulcel'8 and denture
Iirritation for adults and children over 12 years.
2. What you naed to know before you use Anbnol
I
Adult Strength Gel
Do not uaa Anbeaol Adult Strength Gal:
• If you are allergic to lidocaine hydrochloride, chlorocresol,
I cetylpyridinium chloride, other anaesthetics similar to
lidocaine or any of the other ingredients in this medicine
L (listed In Section 6)._

•--VOu have porpnyna (a pain, constipation, changes in the colour of urine, skin
rashes and disturbed behaviour).
I
Warnings and precautions
Talk to your doctor or pharmacist before using Anbesol
Adult Strength Gel:
I
• If you have open wounds or damaged areas in the
lining of your mouth as this may result in too much of
the active ingredients being absorbed.
• If symptoms continue for more than 7 days or recur
frequently, speak to your pharmacist, doctor or dentist.
Do not use more Anbesol Adult Strength Gel than
I
recommended (as listed In Section 3) as this may result In
the active ingredients being absorbed into the body
causing serious side effects, such as convulsions (fits).
I
Children
Do not give this medicine to children under the age of 12 years.
other medlclnBB and Anbaaol Adult strength Gel
I
Tall your doctor or pharmacist if you are taking, have
recenUy taken or might take any of the following medicines
as they may interfere with Anbesol Adult Strength Gel:
I
• Other anaesthetics or medicines similar to lldocalne for
example antianhythmic drugs such as mexiletine which
are used to control abnormal heartbeats
I
• Erythromycin a type of antibiotic used to treat bacterial
infections
• ltraconazole a type of antlfUngal medicine used to treat I
fungal infections
• Antiarrhythmic drugs such as amiodarona which are
used to control abnormal heartbeats
• Cimelidine used to treat stomach ulcers or heartburn
• Beta-blockers used to treat heart conditions, high blood I
pressure or migraine
• Calcium chloride used for the treatment of
hypocalcaemia or as a food additive
• Codeine phosphate used to treat pain, diarmoea or
relieve coughs
• Diamorphine hydrochloride a painkiller used to treat
severe pain
• Paveretum used to treat moderate to severe pain and I
to calm you before an operation
• Quinine hydrochloride used to treat malaria or leg cramps
• Methylcellulose used to treat constipat~
_J

[" Non~ic surtactan!iSuch 88CetomacrogoTlUOO

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polysorbate 80 which are used in medicines, foods and
cosmetics
IPregnancy, f11rtility and braaat-faading
If you are pregnant, breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
Ior pharmacist for advice before using this medicine.
If you are breast-feeding small amounts of the active
ingredient lidocaine will pass into your breast milk but in
Isuch small quantities that It should not harm your baby If
this medicine is used as directed.
Driving and using machines
!Anbesol Adult Strength Gel is unlikely to affect your ability
to drive or use machines.
IImportant Information about some of the Ingredients
This medicinal product contains chlorocresol and the azo
dye Ponceau 4R (E124) which may cause allergic
lreactions in sensitive individuals.
This medicinal product contains 66.605% ethanol
(alcohol), I.e. up to 0.760 mg per ml, equivalent to 15.2 ml
Ibeer, 6.3 ml wine per dose which may be harmful for those
suffering from alcoholism. To be taken into account in
pregnant or breast-feeding women, children and high risk
groups such as patients with liver disease, or epilepsy.
3. How to use Anbaaol Adult Strength Gel
!Adults, the aldarty and chlldren 12 years and ovar:
• Apply a small amount of Anbesol Adult Strength Gel to
affected area with a clean fingertip.
I· One application should be sufficient to obtain tamporary
pain relief.
1•
Do not apply more frequently than every 3 hours.
If you use more Anbaaol Adult strength Gal than you
should; If anyone used more Anbesol Adult Strength Gel
than they should, or if large quantities of the gel are
laccidentally swallowed, contact your doctor or your
nearest Accident and Emergency department, taking this
Ileaflet and pack with you.
Like all medicines, this medicine may cause side effects,
Ialthough not everybody gets them.
• Allergic reactions (eg difficulty breathing, rash or itch).
L Some people have reported sulfering from ulcers. _

oU&rmi!ltlS (lnflammatlOilof the&l itchy and scaly skin).
Reporting of aide effects
If you gal any side effects, talk to your doctor or
pharmacist. 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/yallowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

5. How to store Anbeaol Adult Strength Gel
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiry date which is stated on th"I
carton and tube after EXP. The expiry data refers to th"I
last day of that month.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These meesuras
will help protect the environment.
I

1. Contenta of the pack and other Information

What AnbBllOI Adult Strength Gal contalna
Anbesol Adult Strength Gel contains the active ingredients; I
lidocaine hydrochloride 2.0%w/w, Chlorocresol 0.1 'Yaw/w
and cetylpyridinium chloride 0.02%w/w.
It also contains alcohol, clove oil, glycerol, hydroxypropyl I
cellulose, sodium saccharin, Ponceau 4R (E124) and
purified waler.
What AnbBllOI Adult Strength Gal looka Ilka and
contenta of the pack
Anbesol Adult Strength Gel is a soft pink clear gel for
oromucosal use supplied In a tube containing 10g.
Marketing Authorisation Holder:
Alliance Pharmaceuticals Limited, Avonbridge House,
Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
Manufactured by: Conforme N.V.,Zenderstraat 10,
B-9070 Destelbergen, Belgium.
This leaflet was last revised in December 2016
Anbesol, Alliance and associated devices are registered
trademarb of Alliance Pharmaceuticals Limited.
@Alliance Pharmaceuticals Limited 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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