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NICORETTE 2MG GUM

Active substance(s): NICOTINE - RESIN COMPLEX

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651369
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.

2 mg and 4 mg Gum
Nicotine chewing gum
What you should know about
nicorette® 2 mg Gum

Benefits you can get from using NRT instead of
smoking

(2 mg nicotine chewing gum)

For the best effect, make sure you chew NICORETTE®
Gum correctly. See ”How to chew NICORETTE®
Gum – the NICORETTE® Chewing Technique”.

nicorette® 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.

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.

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.

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

!

!

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.

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.

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.

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, 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.
 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

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.
 NICORETTE® Gum contains sorbitol. If you have
been told by your doctor that you have an
intolerance to some sugars, talk to your doctor
before taking this medicine.

2 Before using this medicine

!

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.

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

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

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.
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.

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651369
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 a child has used or swallowed the
gums









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.

You may experience unwanted effects because by

Effects of too much nicotine

These effects include:

 feeling faint
 feeling sick (nausea)
 headache
 hiccuping (due to excessive swallowing of
nicotine)

4 Possible side-effects

Effects related to stopping smoking
(nicotine withdrawal)

These effects include:

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

➤ 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.



 chest palpitations, fast heart rate/beat
 sudden reddening of the face and/or neck
 high blood pressure
 sudden constriction of the small airways of the
lung that can cause wheezing and shortness of
breath
 loss or damage to voice
 shortness of breath
 blocked nose, sneezing
 throat tightness
 burping (belching)
 swollen, red, sore tongue
 mouth ulcers or blisters
 numbness or tingling of the mouth
 hives (urticaria)
 excessive sweating
 itching
 rash
 unusual weakness
 jaw-muscle ache
 chest discomfort and pain
 general feeling of discomfort or being unwell
or out of sorts (malaise)

 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

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.

!

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.





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 allergic
reactions (swelling of the mouth, lips, throat and
tongue, itching of the skin, swelling of the skin,
ulceration and inflammation of the lining of the
mouth) stop taking NICORETTE® gum and contact a
doctor immediately.

Very common side-effects:

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

Common side-effects:

(may affect up to 1 in 10 people):
 allergic reactions (hypersensitivity)
 dizziness
 taste disturbance or loss of taste
 tingling or numbness of the hands and feet
 stomach pain or discomfort
 diarrhoea
 dry mouth
 excessive gas or wind
 increased salivation
 sore and inflamed mouth
 sickness (vomiting)
 indigestion
 burning sensation in the mouth
 tiredness (fatigue)

Uncommon side-effects:

(may affect up to 1 in 100 people):
 abnormal dream




Rare side-effects:

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

5 Storing and disposal

 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.
 Do not store NICORETTE® Gum above 25°C.
 Do not use the gum after the ‘Use before’ date
on the box or blister strip.
 Dispose of NICORETTE® Gum sensibly.
 Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer
required. These measures will help to protect
the environment.

6 Further information
What’s in this medicine?

The active ingredient in NICORETTE® 2 mg Gum is
2 mg Nicotine.
The active ingredient in NICORETTE® 4 mg Gum is
4 mg Nicotine.
Other ingredients are: Chewing gum base, sorbitol,
sodium carbonate, flavourings, polacrilin, glycerol and
talc.
The chewing gum base contains butylated hydroxy
toluene (E321), an anti-oxidant.
The 2 mg gum also contains sodium bicarbonate.
The 4 mg gum also contains quinoline yellow (E104)
(yellow colour).
The gum does not contain sugar (sucrose) or animal
products.

Very rare side-effects:

What the medicine looks like

Other side-effects can include:

Who makes nicorette® gum?

(may affect up to 1 in 10,000 people):
 abnormal beating of the heart
 serious allergic reactions which cause difficulty
in breathing or dizziness, swelling of the face or
throat
 blurred vision, watery eyes
 dry throat, lip pain
 stomach discomfort
 redness of the skin
 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.
The following details are applicable for Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

The gums are blister packed in sheets of 6 or 15 and
supplied in packs of packs of 6, 15, 30, 105 or 210
pieces. Not all pack sizes may be marketed.
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 December 2015. ©

Information about
nicorette® ACTIVESTOP®

NICORETTE® ACTIVESTOP® is a support programme
which works with NICORETTE® to support you, with
the aim of helping you give up smoking.
All you need is internet access or download the
NICORETTE® Stop Smoking App.

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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