NICORETTE FRESHMINT 4MG GUM

Active substance: NICOTINE - RESIN COMPLEX

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Transcript
651263
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.

freshmint 2 mg and 4 mg 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 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
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.

!

!

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.

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).
 if you have liver or kidney disease.
 if you have an overactive thyroid gland or have
a phaeochromocytoma (a tumour of the

Some of the ingredients can cause
problems
 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

!

to the “How to stop smoking: your choice”
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 per day.

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.

i

Do not give this product to children under 12
years.

i

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.

When to use nicorette® gum
The following sections contain the dosage
information for 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

Adults and Children 12 years and
over

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

3 How and when to use this
medicine
i

Children under 12 years

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.


turn over 

651263
 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® 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)

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:

 irritability or aggression
 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
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.

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-effect:

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

Rare side-effects
(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).

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 sideeffects 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 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 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 and a mobile
telephone. Call 0800 244 838 for information

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.

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,
 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, 4 mg nicotine gum may be more
appropriate.

2 Before using this medicine
X Do

 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).
 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.
➤ f any of these applies, talk to your doctor,
I
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’’

not use nicorette® gum:

!

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 per day.

dermatitis) or irritation to the eyes and
mucous membranes.
!

If you are pregnant or breast-feeding

If you are pregnant:
1) irstly, you should try to give up smoking
F
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) econdly, if you can’t manage this, you can
S
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) irstly, you should try to give up smoking
F
without NRT.
2) econdly, if you can’t manage this you are
S
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 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.
 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

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.
 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.



Some of the ingredients can
cause problems
 The chewing gum base contains butylated
hydroxy toluene (E321), an anti-oxidant. May
cause local skin reactions (e.g. contact

651212

turn over 

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® 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

 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.
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 and sickness (vomiting)

Uncommon side-effects:

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

If you have used more than the recommended
dosage you may experience nausea (feeling
sick), salivation, pain in your abdomen,
diarrhoea, sweating, headache, dizziness,
Rare side-effects:
hearing disturbance or weakness.
(less than 1 in 1,000 people are affected)
➤ f you do get any of these effects contact a
I
 allergic reactions (swelling of the mouth,
doctor or your nearest hospital Accident and
lips, throat and tongue, itching of the skin,
Emergency department immediately. Take
swelling of skin, ulceration and inflammation
this leaflet and the pack with you.
of the lining of the mouth)

!

If a child has used or swallowed
the gums

➤ ontact a doctor or your nearest hospital
C
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:
 irritability or aggression
 feeling low

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 25ºC.
 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® 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® 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 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

651215

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’’.
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.

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,
 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, 4 mg
nicotine gum may be more appropriate.

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).
 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.
!

3 How and when to use this
medicine
i

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.
 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 per day.

Some of the ingredients can cause
problems
 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 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.

When to use nicorette® gum

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

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.

turn over 

651215
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.
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)

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:
 irritability or aggression
 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

Rare side-effects:
(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).

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

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.

 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 25ºC.
 Do not use the gum after the ‘Use before’ date on
the box.
 Dispose of NICORETTE® gum sensibly.
 For the gums in loose-filled cardboard boxes,
dispose of within 3 months of opening.
 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.

Very common side-effects:

6 Further information

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

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

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 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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