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NICORETTE FRUITFUSION 6MG GUM

Active substance(s): NICOTINE RESINATE

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BRAND: Nicorette Gum Flat leaflet
DATE: 2013-08-13/MPS-j
ARTICLE No: 651253
DESCRIPTION: Nico gum 6mg FF LP MP
REPLACES No: New
COUNTRY: England/GB
SIZE: 280x180 mm -- 2 pages
PMS
COLORS:

Black

355

PDD McNeil, HBG, SWE

August 13, 2013 10:39:37

651253
relief (i.e. greater decrease in craving intensity,
faster craving relief and/or longer craving relief)
when compared to the 4mg gum.





fruitfusion 6 mg gum
Nicotine chewing gum
What you should know about
nicorette® fruitfusion 6 mg gum



What does nicorette® fruitfusion
6 mg gum do?
When you stop smoking, or cut down the number
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® fruitfusion 6 mg
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® fruitfusion 6 mg 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® fruitfusion 6mg gum correctly. See
‘’How to chew NICORETTE® fruitfusion 6 mg 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.

(6 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® fruitfusion 6 mg gum is a nicotine
replacement therapy (NRT) for heavy smokers.
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® fruitfusion 6 mg 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® fruitfusion 6 mg gum to
achieve this by using it to completely replace all
your cigarettes.
However NICORETTE® fruitfusion 6 mg 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.
The initial dosage should be individualised based
on your nicotine dependence:
 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 or 6mg nicotine gum may be more
appropriate. The 6 mg gum is particularly
recommended if you require enhanced craving

 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).
 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®
fruitfusion 6 mg 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.

2 Before using this medicine

X Do not use nicorette® fruitfusion
6 mg 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.

!

Some of the ingredients can cause
problems
 NICORETTE fruitfusion 6 mg gum contains
butylated hydroxy toluene (E321), an
anti-oxidant, which may irritate your mouth.
®

!

If you are pregnant or breast-feeding

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® fruitfusion 6 mg 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®
fruitfusion 6 mg 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® fruitfusion
6 mg gum
The table below contains the dosage information
for NICORETTE® fruitfusion 6 mg gum. 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
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® fruitfusion
6 mg 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® fruitfusion 6 mg
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.

i

Children under 12 years

Do not give this product to children under 12
years.

i

Adults and Children 12 years and
over

Number of
cigarettes you
smoke per day
20 cigarettes
or fewer
More than
20 cigarettes
as required to
relieve cravings
More than
20 cigarettes
requiring strong
craving relief



Dose of Gums
One 2 mg gum as
required to relieve cravings.
One 4 mg gum as
required to relieve cravings.
One 6 mg gum as required to
provide enhanced craving relief
(i.e. decrease in craving
intensity, faster craving relief
or longer craving relief) when
compared to the 4mg gum

 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.
 Children aged between 12 to 18 years, should
consult with a doctor, nurse or pharmacist
before starting to use this product.
i

If you smoke more than
20 cigarettes and experience
excessive side-effects
When using the highest strength 6 mg gum, if you
experience excessive side-effects, discard the gum
and increase the period of time taken between


turn over 

651253
each gum. If you continue to experience
side-effects, you should switch to the 4 mg gum.
i How to chew nicorette® fruitfusion

6 mg gum – the nicorette® Chewing
Technique

The method of chewing NICORETTE® fruitfusion
6 mg gum is not the same as for ordinary chewing
gum. NICORETTE® fruitfusion 6 mg gum is chewed
to release nicotine then rested so that nicotine can
be taken in through the lining of the mouth. If
NICORETTE® fruitfusion 6 mg 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 fruitfusion 6mg
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.

i

How to stop smoking
If you are able to stop smoking you should use
NICORETTE® fruitfusion 6 mg 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®
fruitfusion 6 mg gum. There are toxins in
cigarettes that can cause harm to your body.
NICORETTE® fruitfusion 6 mg 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® fruitfusion 6 mg 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® fruitfusion 6 mg 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),
vomiting, increased 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® fruitfusion 6 mg 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)

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® fruitfusion 6 mg
gum before you are ready to reduce your nicotine
intake.
! These effects include:
 Irritability, frustration or anger
 feeling low
 anxiety
 restlessness or impatience
 poor concentration
 increased appetite or weight gain
 urges to smoke (craving)
 night time awakening or sleep disturbance
 lowering of heart rate
 bleeding gums or mouth ulcers
 dizziness or light headedness
 sore throat or cold-like symptoms
 cough
 constipation

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, vomiting)
 headache
 hiccuping (due to excessive swallowing of nicotine)

Side-effects of nicorette® fruitfusion
6 mg gum
NICORETTE® fruitfusion 6 mg 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 using either the 2 or 4 mg gum.
The gum may occasionally stick to dentures and in
rare cases damage them.
If you notice any of the following 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) stop taking
nicorette fruitfusion gum and contact a doctor
immediately.

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
 tingling or numbness of the hands and feet

Common side-effects:

(less than 1 in every 10 people are affected)
 dizziness
 indigestion
 sickness (vomiting)
 increased amount of saliva

Uncommon side-effects:

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

Very rare side-effects:

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

5 Storing and disposal

 Keep NICORETTE® fruitfusion 6 mg 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.
 This medicinal product does not require any
special temperature storage conditions. Store in
original container to protect from light.
 Do not use the gum after the ‘Use before’ date on
the box.
 For the gums in loose-filled cardboard boxes,
dispose of within 3 months of opening.

 Dispose of NICORETTE® fruitfusion 6mg 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
6 mg Gum is 6 mg nicotine.
Other ingredients in NICORETTE® fruitfusion 6 mg
gum are: Chewing gum base, xylitol (E967),
peppermint oil, sodium carbonate (E500),
acesulfame potassium (E950), levomenthol,
magnesium oxide (E530), Tuttifrutti flavour,
hypromellose (E464), sucralose (E955), polysorbate
80 (E433), acacia, titanium dioxide (E171) and
carnauba wax (E903). The chewing gum base
contains butylated hydroxytoluene (E321), an
anti-oxidant.
The gums do not contain sugar (sucrose) or animal
products.

What the medicine looks like

NICORETTE® fruitfusion 6 mg gum is a whitish square
coated piece of gum.
Pack types and pack sizes:
The gums are blister packed in sheets of 15 and
supplied in packs of 105 or 210 pieces.
The gums are loose-fill packed in a box, wrapped in a
transparent plastic film, supplied in packs of 100
(4x25) and 200 (8x25) pieces.
Not all pack sizes may be marketed.

Who makes nicorette® fruitfusion
6 mg gum?

The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg, Sweden.
The leaflet was prepared in August 2013.©

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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