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NICORETTE FRESHFRUIT 2 MG GUM

Active substance: NICOTINE RESINATE

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651298




of cigarettes you smoke, your body misses the
nicotine that you have been absorbing. You may
experience unpleasant feelings and a strong
desire to smoke (craving). This indicates that you
were dependent on nicotine.
When you chew NICORETTE® gum, nicotine is
released and passes into your body through the
lining of your mouth. The nicotine released from
the gum is sufficient to relieve the unpleasant
withdrawal symptoms. It will also help to stop the
craving to smoke, but NICORETTE® gum will not give
you the “buzz’’ you get from smoking a cigarette.
Benefits you can get from using NRT instead of
smoking
For the best effect, make sure you chew NICORETTE®
gum correctly. See ‘How to chew NICORETTE®
(gum - the NICORETTE® chewing technique’.
The benefits of stopping smoking far outweigh
any potential risk from using nicotine from NRT.
It is the toxins in cigarette smoke such as tar, lead,
cyanide and ammonia that cause smoking related
disease and death, not the nicotine.

You may think that smoking helps relieve
feelings of anxiety and stress, but it does not
deal with the cause of the stress and leads to a
number of serious diseases. In addition, the
feeling of relaxation after smoking is temporary,
with withdrawal symptoms and cravings soon
returning.
Nicotine replacement therapy can help relieve
nicotine withdrawal symptoms such as irritability,
low mood, anxiety, restlessness and cravings
when used in place of cigarettes.

NRT may benefit smokers who want to quit, by
helping to control weight gain that may be
experienced when trying to stop smoking.
Use of NRT is safer than smoking tobacco but as
soon as you are ready, you should aim to stop
smoking completely.

fruitfusion 2 mg and 4 mg gum
Nicotine chewing gum
What you should know about
nicorette® fruitfusion 2 mg gum
(2 mg nicotine chewing gum)
nicorette® fruitfusion 4 mg gum
(4 mg nicotine chewing gum)
Please read this leaflet carefully before you start
using this medicine. It provides useful information
on how to use it safely. Keep the leaflet, you
might need it again.
If you think you are having side-effects, have any
questions or are not sure about anything please
ask your doctor, nurse or pharmacist.

1 What the medicine is for

NICORETTE gum is a nicotine replacement therapy
(NRT).
It is used to relieve and/or prevent withdrawal
symptoms and reduce the cravings for nicotine
that you get when you try to stop smoking, or
when cutting down the number of cigarettes you
smoke.
NICORETTE® gum can also be used when you are
pregnant or breast-feeding to help you stop
smoking, as the risks to your baby are far less than
if you continue to smoke.
For more information, see ’If you are pregnant or
breast-feeding’ section.
Ideally you should always aim to stop smoking.
You can use NICORETTE® gum to achieve this by
using it to completely replace all your cigarettes.
However NICORETTE® gum can also be used in
other ways,
 if you feel unable to stop smoking completely,
or wish to replace certain cigarettes and
therefore it can help you to cut down the
number of cigarettes you smoke,
 at those times when you can’t or do not want
to smoke. For example,
- Where you don’t want to smoke and avoid
harm to others e.g children or family.
- Smoke free areas e.g Pub, work, public
transport e.g aeroplanes.
It may also help increase your motivation to quit.
When making a quit attempt a behavioural
support programme will increase your chances of
success. Details of NICORETTE® ActiveStop are at
the end of this leaflet.
If you smoke 20 or fewer cigarettes a day, the 2 mg
nicotine gum will help relieve your cravings.
If you smoke more than 20 cigarettes a day, the
4 mg nicotine gum may be more appropriate.
®



What does nicorette® gum do?
When you stop smoking, or cut down the number

2 Before using this medicine
X Do not use nicorette® gum:

 if you are a child under 12 years of age.
 if you have an allergy to nicotine or any of the
other ingredients.

!

Talk to your doctor, nurse or
pharmacist…
 if you are pregnant or breast-feeding – you may
be able to use nicotine replacement therapy
(NRT) to help you give up smoking but you
should try to give up without it. See ”If you are
pregnant or breast-feeding” section.
 if you are in hospital because of heart disease
(including heart attack, disorders of heart rate
or rhythm, or stroke).
In other heart conditions not requiring you to
be in hospital, using NRT is better than
continuing to smoke.
 if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation
of the oesophagus (passage between the mouth
and stomach).

to the “How to stop smoking’’ section, which will help
you decide which method to use to give up smoking.
 Use the “How to chew NICORETTE® gum - the
NICORETTE® chewing technique” instructions
which follow. The method of chewing is NOT
the same as that for ordinary chewing gum.
This way of chewing ensures that the nicotine is
correctly released from the gum.
 The number of NICORETTE® gums you use each
day will depend on how many cigarettes you
smoked and how strong they are. See the dosing
table to find out the dose you should take.
 The 2 mg gums should be used by people who
smoke 20 or fewer cigarettes each day or by
heavier smokers when they are cutting down
the number and strength of the NICORETTE®
gums they are using.
 The 4 mg gums should be used by people who
smoke more than 20 cigarettes each day.

 if you have liver or kidney disease.
 if you have an overactive thyroid gland or have
a phaeochromocytoma (a tumour of the
adrenal gland that can affect blood pressure) –
your doctor will have told you this.
 if you have diabetes – monitor your blood
sugar levels more often when starting to use
NICORETTE® gum as you may find your insulin
or medication requirements alter.
 if you are taking other medicines such as
theophylline, clozapine or ropinirole. Stopping
smoking or cutting down may require the dose
of these medicines to be adjusted.
➤ If any of these applies, talk to your doctor,
nurse or pharmacist.
!

Some of the ingredients can cause
problems
 NICORETTE® fruitfusion gum contains butylated
hydroxy toluene (E321), an anti-oxidant, which
may irritate your mouth.

!

i

Children under 12 years

If you are pregnant or breast-feeding

i

Adults and Children 12 years and
over

If you are pregnant:
1) Firstly, you should try to give up smoking without
NRT. Stopping completely is by far the best
option. The earlier and quicker you do this the
better it is for you and your baby.
2) Secondly, if you can’t manage this, you can use
NRT as a safer alternative to smoking as the risks
to your baby are far less than smoking, however
you should talk to your doctor, nurse or
pharmacist for advice.
Products that are used intermittently, including
NICORETTE® gum, may be preferable to nicotine
patches. However, patches may be more suitable if
you have nausea or sickness. If you do use patches
take them off before going to bed at night.
If you are breast-feeding:
1) Firstly, you should try to give up smoking
without NRT.
2) Secondly, if you can’t manage this you are best
to use NRT products that are taken intermittently
(not patches), however you should talk to your
doctor, nurse or pharmacist for advice.
Breast-feed just before you use NICORETTE®
gum to ensure that the baby gets the smallest
amount of nicotine possible.
If you do need to use NRT to help you quit, the
amount of nicotine that the baby may receive is
considerably smaller and less harmful than the
second-hand smoke they would inhale if you
smoked. Tobacco smoke produces breathing and
other problems in babies and children.

3 How and when to use this
medicine
i

When to use nicorette® gum
The table below contains the dosage information
for NICORETTE® gums. This shows the number of
gums you should be using, when and how you
should take them.
Please read this information carefully and then go

Do not give this product to children under 12 years.

Number of
cigarettes you
smoke per day
20 cigarettes
or fewer
More than
20 cigarettes

Dose of Gums
One 2 mg gum as
required to relieve cravings.
One 4 mg gum as
required to relieve cravings.

 Use only one piece of gum at a time.
 Do not use more than 15 gums per day.
 The frequency with which you use the gums
will depend on how many cigarettes you
smoked and how strong they were.
i

How to chew nicorette® gum – the
nicorette® chewing technique
The method of chewing NICORETTE® gum is not the
same as for ordinary chewing gum. NICORETTE®
gum is chewed to release nicotine then rested so
that nicotine can be taken in through the lining of
the mouth. If NICORETTE® gum is chewed
continuously, the nicotine is released too quickly
and is swallowed. This may irritate your throat,
upset your stomach or give you hiccups.
If you have false teeth you may have difficulty
chewing the gum as NICORETTE® gum could stick
to them and on rare occasions, damage dentures.
If you experience a problem, other types of
nicotine replacement therapy such as a skin patch,
inhalator or microtab may be more suitable for you.

i

The nicorette® chewing technique
1. Chew slowly until taste becomes strong.
2. Rest between gum and cheek.
3. Chew again when the taste has faded.
 Keep chewing like this for about half an hour.
After this time the gum will have lost its
strength and you should dispose of it carefully.

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651298
i How to stop smoking:
If you are able to stop smoking you should use
NICORETTE® gum, when needed, in place of
cigarettes. As soon as you can (this could be after a
number of weeks or months) you should reduce
the number of gums you use until you have
stopped using them completely.
If you are unable to stop smoking or do not feel
ready to quit at this time, you should replace as
many cigarettes as possible with NICORETTE® gum.
There are toxins in cigarettes that can cause harm
to your body. NICORETTE® gum provides a safer
alternative to smoking, for both you and those
around you. Reducing the number of cigarettes
may also help you to become more motivated to
stop smoking. As soon as you are ready you should
aim to stop smoking completely.
You can also use NICORETTE® gum on those
occasions when you can’t or don’t want to smoke
e.g. Social situations such as a party, in the pub or
when at work.
When making a quit attempt behavioural therapy,
advice and support will normally improve the
success rate. If you have quit smoking and want to
stop using NICORETTE® gum but are finding this
difficult you should contact your doctor, nurse or
pharmacist for advice.
!

If you have used too many gums
If you have used more than the recommended
dosage you may experience nausea (feeling sick),
salivation, pain in your abdomen, diarrhoea,
sweating, headache, dizziness, hearing disturbance
or weakness.
 If you do get any of these effects contact a
doctor or your nearest hospital Accident and
Emergency department immediately. Take this
leaflet and the pack with you.

!

If a child has used or swallowed the
gums
 Contact a doctor or your nearest hospital
Accident and Emergency department
immediately if a child under 12 years uses,
chews or swallows this medicine. Take this
leaflet and the pack with you.
Nicotine ingestion by a child may result in
severe poisoning.

4 Possible side-effects

Like all medicines, NICORETTE® gum can have side-effects.
As many of the effects are due to nicotine, they can
also occur when nicotine is obtained by smoking.

Effects related to stopping smoking
(nicotine withdrawal)










 feeling low
 anxiety
 restlessness
 poor concentration
 increased appetite or weight gain
 urges to smoke (craving)
 night time awakening or sleep disturbance
 lowering of heart rate

Effects of too much nicotine

You may also get these effects if you are not used to
inhaling tobacco smoke.
!
These effects include:
 feeling faint
 feeling sick (nausea)
 headache
 hiccuping (due to excessive swallowing of nicotine)

Side-effects of nicorette® gum

NICORETTE® gum can sometimes cause a slight
irritation of the throat at the start of the treatment. It
may also cause increased salivation.
Those who suffer from indigestion may suffer from
heartburn or indigestion and may benefit from slower
chewing and use of the 2 mg gum.
The gum may occasionally stick to dentures and in
rare cases damage them.

Very common side-effects:

(more than 1 in every 10 people are affected):
 headache
 sore mouth or throat
 jaw-muscle ache
 stomach discomfort
 feeling sick (nausea)
 hiccups

Common side-effects:

(less than 1 in every 10 people are affected):
 dizziness
 sickness (vomiting)

Uncommon side-effects:

(less than 1 in every 100 people are affected):
 hives (urticaria)
 redness or itching of the skin
 chest palpitations

Rare side-effects:

You may experience unwanted effects because by
stopping smoking you have reduced the amount of
nicotine you are taking. You may also experience
these effects if you under use NICORETTE® gum
before you are ready to reduce your nicotine intake.

(less than 1 in 1,000 people are affected):
 allergic reactions (swelling of the mouth, lips,
throat and tongue, itching of the skin, swelling of
skin, ulceration and inflammation of the lining of the
mouth).

! These effects include:
 irritability or aggression

Very rare side-effects:

(less than 1 in 10,000 people are affected):
 abnormal beating of the heart

➤ If you notice these or any other unwanted effects
not listed in this leaflet tell your doctor, nurse or
pharmacist.
Also you can help to make sure medicines remain
as safe as possible by reporting any unwanted
side-effects via the internet at www.mhra.gov.uk/
yellowcard; alternatively you can call Freephone
0808 100 3352 (available between 10am – 2pm
Monday to Friday) or fill in the paper form available
from your local pharmacy.
➤ When you stop smoking you may also develop
mouth ulcers. The reason why this happens is
unknown.

5 Storing and disposal
 Keep NICORETTE® gum out of reach and sight of
children and animals. Nicotine in high doses can
be very dangerous and sometimes fatal if taken by
small children.
 Do not store NICORETTE® gum above 25°C.
 Do not use the gum after the ‘Use before’ date on
the box or blister strip.
 Dispose of NICORETTE® gum sensibly.
 Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

6 Further information
What’s in this medicine?

The active ingredient in NICORETTE® fruitfusion 2 mg
gum is 2 mg nicotine.
Other ingredients in NICORETTE® fruitfusion 2 mg
gum are: Chewing gum base, xylitol, acesulfame
potassium, sodium carbonate, sodium hydrogen
carbonate, peppermint oil, levomenthol, magnesium
oxide, titanium dioxide (E171), acacia, carnauba wax,
Tuttifrutti QL84441, hypromellose, sucralose,
polysorbate 80 and talc. The chewing gum base
contains butylated hydroxytoluene (E321), an
anti-oxidant.
The active ingredient in NICORETTE® fruitfusion 4 mg
gum is 4 mg nicotine.
Other ingredients in NICORETTE® fruitfusion 4 mg
gum are: Chewing gum base, xylitol, peppermint oil,
anhydrous sodium carbonate, acesulfame potassium,
levomenthol, magnesium oxide, quinoline yellow
Al-lake (E104), talc, Tuttifrutti QL84441, hypromellose,
sucralose, polysorbate 80, acacia, titanium dioxide
(E171) and carnauba wax. The chewing gum base
contains butylated hydroxytoluene (E321), an
anti-oxidant.
None of the gums contain sugar (sucrose) or animal
products.

What the medicine looks like

NICORETTE® fruitfusion 2 mg gum is a whitish square
coated piece of gum.
NICORETTE® fruitfusion 4 mg gum is a crème square
coated piece of gum.

Pack types and pack sizes:
The gums are blister-packed in sheets of 6, 10 or 15
and supplied in packs of 10, 12, 15, 30, 105 and 210
pieces.
The gums are loose-filled packed in a cardboard box,
wrapped in a transparent plastic film, containing 25
pieces and supplied in packs of 25, 100 (4x25) and
200 (8x25).
Not all pack types and sizes may be marketed.

Who makes nicorette® gum?

The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg, Sweden.
This leaflet was revised in August 2012.©

Information about nicorette®
ActiveStop

NICORETTE® ActiveStop is a personalised support
programme which works with NICORETTE® to support
you, with the aim of helping you give up smoking.
All you need is internet access.
Call 0800 244 838 for information.

Expand view ⇕

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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