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AMETOP GEL 4% W/W

Active substance(s): TETRACAINE HYDROCHLORIDE

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NON-PRINT AREA

*smith&nephew

AMETOP™ 40mg/g GEL
Tetracaine 40mg/g (4%w/w)

Read this entire leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use AMETOP Gel
carefully to get the best results from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What AMETOP Gel is and what it is used for.
2. Before you use AMETOP Gel.
3. How to use AMETOP Gel.
4. Possible side effects.
5. How to store AMETOP Gel.
6. Further information.

1. What AMETOP Gel is and what it is
used for
AMETOP Gel is a local anaesthetic which numbs
the skin.
AMETOP Gel is used:
• when needles are inserted into a vein for
giving an injection or taking a blood sample.
• to relieve the pain of inserting small plastic
tubes (cannulae) into veins for putting up
drips.

2.Before you use AMETOP Gel
Do not use AMETOP Gel:
• if you are allergic (hypersensitive) to
tetracaine or any of the other ingredients of
AMETOP Gel (see Section 6).
• if you are allergic (hypersensitive) to any other
local anaesthetics.
• if you are pregnant or breast-feeding.
• if the patient is less than 1 month old.
• If the patient is a premature baby up until one
month after the expected delivery date
(44 weeks gestation).
• on wounds
• on broken skin
• on lips, mouth or tongue
• on eyes or ears
• on anal and genital regions.

Take special care with AMETOP Gel
• if you suffer from epilepsy.
Do not swallow AMETOP Gel
Important information about some of the
other ingredients in AMETOP Gel:
AMETOP Gel contains Sodium methyl
parahydroxybenzoate (E219) and Sodium propyl
parahydroxybenzoate (E217) as excipients which
may cause allergic reactions (possibly delayed).
Using other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not use if you are pregnant, thinking of
becoming pregnant, or breast-feeding.
Ask your doctor or pharmacist before taking or
using any medicines.
Driving and using machinery
AMETOP Gel is unlikely to affect driving or the
use of machines.

3.How to use AMETOP Gel
Adults, including the elderly and children over
5 years of age:
• A maximum of 5 tubes (approximately 5g) can
be applied at separate sites at the same time
Children over 1 month of age and under 5
years of age:
• No more than 1 tube should be applied at a
single time but this may be split over
separate sites.
• Do not use if the patient is less than 1 month
old or if the patient is a premature baby up
until one month after the expected delivery
date (44 weeks gestation).
Application of AMETOP Gel can be repeated after
a minimum of 5 hours if necessary.
• The maximum dose in a 24-hour period
should not exceed 7 tubes for adults and
2 tubes for children.
Your doctor, nurse or pharmacist will tell you
where on the skin you need to apply the
medicine. One tube of AMETOP Gel can cover
an area of up to 30 sq cm (6cm x 5cm or
21/2in. x 2in.).
This medicine may be administered by a doctor,
nurse or pharmacist. If not, you should carry out
the following steps:

• To open the tube, invert the cap and pierce
the seal.
1
• Apply the contents
of the tube on the
area of the skin to be
numbed. Do not rub
the gel into the skin.
• The mound of gel
should then be
covered with a
plastic film dressing
1. Pierce nozzle using
spiked cap. Empty tube
which may be
to form a mound of gel
supplied by your
doctor or pharmacist. at required site.
• Each tube is intended for use on a single
occasion only.
How to apply the plastic film dressing
Apply the plastic film dressing as per the
manufacturer’s instructions.
• Place the dressing
2
over the mound of
gel and down around
the edges of the gel.
• If no plastic dressing
is supplied to you,
the mound of gel can
be covered by clear
plastic kitchen wrap.
• The gel must be
2. Smooth down edges of
covered for it to work. dressing. Record the time
of completed application.
• It will not work if you
rub it in like an ointment.
After 30-45 minutes, or as recommended by your
doctor or pharmacist:
• The dressing should be removed and the gel
wiped off the skin with a clean tissue
• Dispose of these carefully out of the reach
of children
• AMETOP Gel should not be left on for more
than 1 hour
• The site will remain numb for about
4-6 hours.
Take care to minimise contact with AMETOP Gel
(except for the area of skin to be numbed) during
application and removal. Allergic reactions to this
product can occur, especially following repeated
contact.
If the product comes into contact with the eyes,
ears, mouth, tongue or nose you should
immediately rinse the affected area and contact
your doctor or pharmacist for further advice. Only
apply to intact, healthy skin.
If you use more AMETOP Gel than you should
or if you swallow AMETOP Gel
You may experience tingling, numbness in your
tongue, ringing in your ears (tinnitus), feeling sick
or actually being sick, twitching and fitting if you
use more AMETOP Gel than you should or if you
swallow AMETOP Gel. You should contact your
doctor immediately.

4.Possible side effects
Like all medicines AMETOP Gel can cause side
effects, although not everyone gets them. The
following side effects may happen with this
medicine:

Frequently;
• redness of the skin at the numbed site.
Less Frequently;
• itching and swelling of the skin at the
numbed site.
Rarely;
• more severe redness, swelling and/or
itching at the numbed site.
Very Rare:
• blistering of the skin at the numbed site. If
blistering occurs remove the AMETOP Gel
immediately using a clean tissue and
contact your doctor or pharmacist.
The risk of these side effects happening may
increase with repeated use.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store AMETOP Gel
• Keep out of the reach and sight of children.
• Use once, then discard.
• Store in a refrigerator at 2-8°C. Do not
freeze. Protect from heat.
• If not stored in a refrigerator AMETOP Gel
must be used within 1 month.
• The expiry date is printed on the base of the
tube and on the carton (MM / YYYY). The
medicine can be used until the end of the
month stated. Do not use your medicine
after this date.

6.Further Information
What AMETOP Gel contains
• The active substance tetracaine.
• AMETOP Gel: the other ingredients are
purified water, sodium chloride, potassium
dihydrogen phosphate, xanthan gum (E415),
sodium hydroxide (E524) and sodium methyl
parahydroxybenzoate (E219) and sodium
propyl parahydroxybenzoate (E217).
What AMETOP Gel looks like and the contents
of the pack
AMETOP Gel is a white semi-transparent gel
containing 4%w/w of tetracaine. Each gram of
gel contains 40mg of tetracaine. Each tube
contains 1.5g of AMETOP Gel from which 1g
(40mg tetracaine) can be squeezed.
Marketing Authorisation Holder
Smith & Nephew Healthcare Limited,
Healthcare House, 101 Hessle Road,
Hull HU3 2BN, United Kingdom.
UK Product Licence (PL 14038/0001).
Irish Product Authorisation (PA 768/1/1).
Manufacturer
Perstorp Specialty Chemicals AB,
Perstorp Pharma, SE-284 80 Perstorp, Sweden.
Date of Preparation: August 2010
™Trade Mark of Smith & Nephew

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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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