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NICORETTE FRUITFUSION 6MG GUM

Active substance(s): NICOTINE RESINATE / NICOTINE RESINATE / NICOTINE RESINATE

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Brand: Nicorette
BRAND
Product: Gum_6mg_CF_leaflet
NICORETTE
Component code: 651534
PRODUCT
Version number: LKL-hGum 6 mg CF Leaflet
COMPONENT CODE
Dimension: 560 x 180 mm
651534
Text font: 9 pt
REPLACED COMP CODE
651421

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-h

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020025

560x180mm

9 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 21, 2017 14:16:06

- Where you don’t want to smoke and avoid harm to others
e.g children or family.

fruitfusion 6 mg gum
Nicotine chewing gum
What you should know about
nicorette® fruitfusion 6 mg gum
(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 breastfeeding’’ 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,
n 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,
n at those times when you can’t or do not want to smoke.
For example,

- 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.
The initial dosage should be individualised based on your
nicotine dependence:
n If you smoke 20 or fewer cigarettes a day, the
2 mg nicotine gum will help relieve your cravings.
n If you smoke more than 20 cigarettes a day, the 4 or 6 mg
nicotine gum may be more appropriate. The 6 mg gum is
particularly recommended if you require enhanced craving
relief (i.e. greater decrease in craving intensity, faster
craving relief and/or longer craving relief) when compared
to the 4 mg gum.

n if you have liver or kidney disease.

If you are breast-feeding:
1) Firstly, you should try to give up smoking without NRT.

n 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.

n 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.
n 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.

n 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.

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.

2 Before using this medicine
X

Some of the ingredients can cause
problems

!

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.

Talk to your doctor, nurse or pharmacist…

n 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.
n if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation of the
oesophagus (passage between the mouth and stomach).

i

The table 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.
n 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.

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.

When to use nicorette® fruitfusion
6 mg gum

®

If you are pregnant or breast-feeding
If you are pregnant:

n 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.

3 How and when to use this medicine

n NICORETTE® fruitfusion 6 mg gum contains butylated
hydroxy toluene (E321), an anti-oxidant, which may irritate
your mouth.

Do not use nicorette fruitfusion 6 mg gum:
n if you have an allergy to nicotine or any of the other
ingredients.

!

!

n If you are a child under 12 years of age.

®

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.

n 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 apply, talk to your doctor, nurse or
pharmacist.

i

n 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.

Adults and Children 12 years and over

651534

Number of cigarettes
you smoke per day

Dose of Gums

20 cigarettes
or fewer

One 2 mg gum as required
to relieve cravings.

More than 20
cigarettes as required
to relieve cravings

One 4 mg gum as required
to relieve cravings.

More than
20 cigarettes
requiring strong
craving relief

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 4 mg gum

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

651534

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 6 mg 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.
n 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

!

n 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
n 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

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

n sore throat or cold-like symptoms
n cough
n constipation

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.

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:

n irritability, frustration or anger
n feeling low
n anxiety
n restlessness or impatience
n poor concentration
n increased appetite or weight gain
n urges to smoke (craving)
n night time awakening or sleep disturbance
n lowering of heart rate
n bleeding gums or mouth ulcers
n dizziness or light headedness

Effects of too much nicotine
You may also get these effects if you are not used to inhaling
tobacco smoke.
!

These effects include:

n feeling faint
n feeling sick (nausea, vomiting)
n headache
n 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; fast heart rate/beat,
abnormal beating of the heart, chest palpitations, shortness
of breath or allergic reactions (swelling of the face, mouth,
lips, throat and tongue, itching of the skin, swelling of skin,
ulceration and inflammation of the lining of the mouth,
difficulty in breathing and dizziness) stop taking NICORETTE®
fruitfusion gum and contact a doctor immediately.

Very common side-effects:
(more than 1 in every 10 people are affected)
n headache
n cough
n throat irritation
n stomach discomfort
n feeling sick (nausea)
n hiccups
n sore mouth or throat
n jaw-muscle ache
n tingling or numbness of the mouth

Common side-effects:

Rare side-effects:

(less than 1 in every 10 people are affected)
n allergic reactions (hypersensitivity)
n dizziness
n taste disturbance or loss of taste
n tingling or numbness of the hands and feet
n stomach pain or discomfort
n diarrhoea
n dry mouth
n excessive gas or wind
n indigestion
n increased salivation
n sore and inflamed mouth
n sickness (vomiting)
n burning sensation in the mouth
n tiredness (fatigue)

(less than 1 in every 1,000 people are affected)
n difficulty in swallowing
n decreased feeling or sensitivity, especially in the mouth
n feeling of wanting to be sick (vomit)

Uncommon side-effects:
(less than 1 in every 100 people are affected)
n abnormal dream
n sudden reddening of the face and/or neck
n high blood pressure
n sudden constriction of the small airways of the lung that
can cause wheezing and shortness of breath
n loss or damage to voice
n blocked nose, sneezing
n throat tightness
n burping (belching)
n swollen, red, sore tongue
n mouth ulcers or blisters
n numbness or tingling of the mouth
n redness of the skin
n hives (urticaria)
n excessive sweating
n itching
n rash
n unusual weakness
n chest discomfort and pain
n general feeling of discomfort or being unwell or out of
sorts (malaise)

Other side-effects can include:
n blurred vision, watery eyes dry throat, lip pain
➤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
n Keep NICORETTE® fruitfusion 6 mg gum out of the
sight and reach children and animals. Nicotine in high
doses can be very dangerous and sometimes fatal if taken
by small children.
n This medicinal product does not require any special
temperature storage conditions. Store in original container
to protect from light.
n Do not use the gum after the ‘Use before’ date on the box.
n For the gums in loose-filled cardboard boxes, dispose of
within 3 months of opening.
n Dispose of NICORETTE® fruitfusion 6 mg gum sensibly.
n 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 June 2017.

Expand Transcript

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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