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NICASSIST MINTY FRESH 4 MG GUM

Active substance(s): NICOTINE - RESIN COMPLEX / NICOTINE - RESIN COMPLEX / NICOTINE - RESIN COMPLEX

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Brand: Nicorette
BRAND
Product: Gum_2_4mg_S&S_leaflet
NICORETTE
Component code: 651529
PRODUCT
Version number: LKL-gGum 2-4 mg S&S Leaflet
Dimension: 560 x 180 COMPONENT
mm CODE
651529
Text font: 9 pt
REPLACED COMP CODE
651373

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-g

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020025

560x180mm

9 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 22, 2017 11:45:27

(2 mg nicotine chewing gum)

- 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.
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.

nicorette® freshmint 4 mg gum

What does nicorette gum do?

freshmint 2 mg and 4 mg gum
What you should know about
nicorette® freshmint 2 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,
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,
- Where you don’t want to smoke and avoid harm to others
e.g children or family.

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.

X

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.

Do not use nicorette® gum:

!

n if you have an allergy to nicotine or any of the other
ingredients.

Talk to your doctor, nurse or pharmacist…
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.
n if you are in hospital because of heart disease
(including heart attack, disorders of heart rate or rhythm,
angina, high blood pressure 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).
n if you have liver or kidney disease.
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® gum as you
may find your insulin or medication requirements alter.
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.

NICORETTE®. This shows the number of gums you should
be using, when you should take them, how you should take
them and the maximum amount of time you should be using
Nicotine Replacement Therapy (NRT) for.
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.

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®
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.

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

!

Some of the ingredients can cause
problems
n The chewing gum base contains butylated hydroxy toluene
(E321), an anti-oxidant. May cause local skin reactions
(e.g. contact dermatitis) or irritation to the eyes and
mucous membranes.

2 Before using this medicine

®

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® 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.

!

3 How and when to use this medicine
i

When to use nicorette® gum

The following sections contain the dosage information for

i

i

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

Dose of Gums

20 cigarettes
or fewer

One 2 mg gum as
required to relieve cravings.

More than
20 cigarettes

One 4 mg gum as
required to relieve cravings.

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.

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.

n 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.
n The 4 mg gums should be used by people who smoke
more than 20 cigarettes per day.

651529

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.

n 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.
n 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.

How to chew nicorette® gum – the
nicorette® chewing technique

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.
turn over ➤

651529

!

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.

n poor concentration
n increased appetite or weight gain
n urges to smoke (craving)
n night time awakening or sleep disturbance
lowering of heart rate

If you have used too many gums

Effects of too much nicotine

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

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
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)

!

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)
n headache
n hiccupping (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.
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 the
skin, ulceration and inflammation of the lining of the mouth,
difficulty in breathing and dizziness) stop taking
NICORETTE® gum and contact a doctor immediately.

Very common 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.

(may affect more than 1 in 10 people):
n headache
n cough
n throat irritation
n (feeling sick) nausea
n hiccups
n sore mouth or throat

These effects include:

Common side-effects:

n irritability or aggression
n feeling low
n anxiety
n restlessness

(may affect up to 1 in 10 people):
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 increased salivation
n sore and inflamed mouth
n sickness (vomiting)
n indigestion
n burning sensation in the mouth
n tiredness (fatigue)

Uncommon side-effects:
(may affect up to 1 in 100 people)
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 unusual weakness
n hives (urticaria)
n excessive sweating
n itching
n rash
n jaw-muscle ache
n chest discomfort and pain
n general feeling of discomfort or being unwell or out of
sorts (malaise)

Rare side-effects
(may affect up to 1 in 1,000 people):
n difficulty in swallowing
n decreased feeling or sensitivity, especially in the mouth
n feeling of wanting to be sick (vomit)

Other side-effects can include:
n blurred vision, watery eyes
n dry throat, lip pain
n stomach discomfort
n redness of the skin
n muscle tightness
➤When you stop smoking you may also develop mouth
ulcers. The reason why this happens is unknown.
➤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.
You can also report side effects directly in Malta via:
ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal

5 Storing and disposal
n Keep NICORETTE® gum out of sight and reach of
children and animals. Nicotine in high doses can be very
dangerous and sometimes fatal if taken by small children.
n Do not store NICORETTE® gum above 25°C.
n Do not use the gum after the ‘Use before’ date on the box
or blister strip.
n Dispose of NICORETTE® gum sensibly.
n Medicines should not be disposed of via waster 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® freshmint 2 mg gum
is 2 mg Nicotine.
The active ingredient in NICORETTE® freshmint 4 mg gum
is 4 mg Nicotine.
Other ingredients are: Chewing gum base, xylitol,
acesulfame potassium, sodium carbonate, peppermint oil,
menthol, polacrilin, magnesium oxide, titanium dioxide E171

(white colour), talc, acacia and carnauba wax. The chewing
gum base contains butylated hydroxytoluene (E321), an
anti-oxidant.
The 2 mg gum also contains sodium bicarbonate.
The 4 mg gum also contains quinoline yellow (E104)
(yellow colour).
None of the gums contain sugar (sucrose) or animal
products).

What the medicine looks like
NICORETTE® freshmint 2 mg gum is a whitish square
coated piece of gum.
NICORETTE® freshmint 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-fill 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 June 2017. ®

BRAND
Brand: Nicorette
NICORETTE
Product: Gum_2_4mg_S&S_leaflet
PRODUCT
Component code: 651530
Gum 2/4mg S&S CO Leaflet
Version number: LKL-j COMPONENT CODE
651530
Dimension: 312 x 284 mm
REPLACED COMP CODE
Text font: 9 pt
651375

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-j

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020032

312x284

9 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 21, 2017 14:45:13

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.
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 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.

freshmint 2 mg and 4 mg gum
Nicotine chewing gum
What you should know about
nicorette® freshmint 2 mg gum
(2 mg nicotine chewing gum)

nicorette® freshmint 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 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,
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,
- 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.
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, 4 mg
nicotine gum may be more appropriate.

2 Before using this medicine
X

Do not use nicorette® gum:

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

Talk to your doctor, nurse or
pharmacist…

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.
n if you are in hospital because of heart disease
(including heart attack, disorders of heart rate or
rhythm, angina, high blood pressure 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).
n if you have liver or kidney disease.
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® gum as you may find your insulin
or medication requirements alter.
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.

What does nicorette® 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® 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’’.

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.

!

Some of the ingredients can cause
problems

n The chewing gum base contains butylated
hydroxy toluene (E321), an anti-oxidant. May
cause local skin reactions (e.g. contact
dermatitis) or irritation to the eyes and mucous
membranes.
!

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

3 How and when to use this
medicine
i

When to use nicorette® gum

The following sections contain the dosage information for NICORETTE® gum. This shows the number
of gums you should be using, when you should take
them, how you should take them and the maximum
amount of time you should be using Nicotine
Replacement Therapy (NRT) for.
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® 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.
n 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.
n 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.

n The 4 mg gums should be used by people who
smoke more than 20 cigarettes per day.
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
Dose of Gums
cigarettes you
smoke per day
20 cigarettes One 2 mg gum as
or fewer required to relieve cravings.
More than One 4 mg gum as
20 cigarettes required to relieve cravings.
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

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.
turn over➤

freshmint • 2mg gum • nicotine
NICORETTE® freshmint gum relieves and/or
prevents withdrawal symptoms including cravings
experienced when trying to stop smoking or cutting
down on cigarettes. It provides a safer alternative to
smoking for both the individual and those around
them. Ideally you should aim to stop smoking.
However, this product can be used either to
completely replace all your cigarettes, or if you do not
feel ready to stop smoking completely, to replace
certain cigarettes and therefore help you to cut down.
It may also help increase your motivation to quit.
Directions: For adults and children 12 years and
over. Please read the attached leaflet carefully before
starting to use the product and note the chewing
technique. Chew one piece of gum when you feel the
urge to smoke. For NICORETTE® chewing technique
refer to top sliding lid of carton. Do not use more than
15 pieces a day.
Warning: Do not take more medicine than
the label tells you to.
If you are pregnant, or you need any other advice
before using this product, talk to your doctor,
pharmacist or nurse. Do not use if you are allergic
to any of the ingredients listed.
You are more likely to quit smoking when
using this product with help from your
pharmacist, doctor, a trained counsellor or a
support programme.

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The nicorette® chewing technique

n increased appetite or weight gain
n urges to smoke (craving)
n night time awakening or sleep disturbance
n lowering of heart rate

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

How to stop smoking:

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)

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.
!

These effects include:

n irritability or aggression
n feeling low
n anxiety
n restlessness
n poor concentration

You may also get these effects if you are not used
to inhaling tobacco smoke.
!

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.
!

Effects of too much nicotine

n excessive sweating
n itching
n rash
n jaw-muscle ache
n chest discomfort and pain
n general feeling of discomfort or being unwell or
out of sorts (malaise)

These effects include:

Rare side-effects:

Side-effects of nicorette® gum

Other side-effects can include:

n feeling faint
n feeling sick (nausea)
n headache
n hiccuping (due to excessive swallowing of
nicotine)
NICORETTE® gum can sometimes cause a slight
irritation of the throat at the start of the
treatment. It may also cause increased salivation.
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 the skin,
ulceration and inflammation of the lining of the
mouth, difficulty in breathing and dizziness) stop
taking NICORETTE® gum and contact a doctor
immediately.

Very common side-effects:
(may affect more than 1 in 10 people):
n headache
n cough
n throat irritation
n (feeling sick) nausea
n hiccups
n sore mouth or throat

Common side-effects:
(may affect up to 1 in 10 people):
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 increased salivation
n sore and inflamed mouth
n sickness (vomiting)
n indigestion
n burning sensation in the mouth
n tiredness (fatigue)

Uncommon side-effects:
(may affect up to 1 in 100 people):
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 unusual weakness
n hives (urticaria)

(may affect up to 1 in 1,000 people):
n difficulty in swallowing
n decreased feeling or sensitivity, especially in the
mouth
n feeling of wanting to be sick (vomit)
n blurred vision, watery eyes
n stomach discomfort
n redness of the skin
n muscle tightness
n dry throat, lip pain
➤When you stop smoking you may also develop
mouth ulcers. The reason why this happens is
unknown.
➤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.
You can also report side effects directly in
Malta via: ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal

What the medicine looks like

NICORETTE® freshmint 2 mg gum is a whitish
square coated piece of gum.
NICORETTE® freshmint 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-fill 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 June 2017 ®.

5 Storing and disposal

n Keep NICORETTE® gum out of sight and
reach of children and animals. Nicotine in high
doses can be very dangerous and sometimes
fatal if taken by small children.
n Do not store NICORETTE® gum above 25ºC.
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® 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® freshmint
2 mg gum is 2 mg Nicotine.
The active ingredient in NICORETTE® freshmint
4 mg gum is 4 mg Nicotine.
Other ingredients are: Chewing gum base, xylitol,
acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide,
titanium dioxide E171 (white colour), talc, acacia
and carnauba wax. The chewing gum base contains
butylated hydroxytoluene (E321), an anti-oxidant.
The 2 mg gum also contains sodium bicarbonate.
The 4 mg gum also contains quinoline yellow
(E104) (yellow colour).
None of the gums contain sugar (sucrose) or
animal products.

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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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