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NICORETTE 4MG GUM

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

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Brand: Nicorette
BRAND
Product: Gum_2_4mg_CL_leaflet
NICORETTE
PRODUCT
Component code: 651528
Gum
Version number: LKL-g 2-4 mg CL Leaflet
COMPONENT CODE
Dimension: 560 x 180
mm
651528
REPLACED COMP CODE
Text font: 9 pt
651369

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 21, 2017 15:10:36

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

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

(2 mg nicotine chewing gum)

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.

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 breastfeeding” 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,

Nicotine replacement therapy can help relieve nicotine
withdrawal symptoms such as irritability, low mood,
anxiety, restlessness and cravings when used in place of
cigarettes.

- Smoke free areas e.g Pub, work, public transport e.g
aeroplanes.

n NRT may benefit smokers who want to quit, by helping to
control weight gain that may be experienced when trying
to stop smoking.

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.

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.
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.

➤If any of these apply, talk to your doctor, nurse or
pharmacist.
!

Use of NRT is safer than smoking tobacco but as soon as
you are ready, you should aim to stop smoking completely.

Do not use nicorette® gum:

!

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.

3 How and when to use this medicine
i

!

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.

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 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.

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.

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
X

If you do need to use NRT to help you quit, the amount of
nicotine that the baby may receive is considerably smaller
and less harmful than the second-hand smoke they would
inhale if you smoked. Tobacco smoke produces breathing
and other problems in babies and children.

n if you are taking other medicines such as theophylline,
clozapine or ropinirole. Stopping smoking or cutting down
may require the dose of these medicines to be adjusted.

i

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.

i

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 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.

Children under 12 years

Do not give this product to children under 12 years.

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.

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.

i

651528

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

®

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

Adults and Children 12 years and 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.
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.
turn over ➤

651528
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.
!

Like all medicines, NICORETTE Gum can have sideeffects. 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.
!

➤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.

These effects include:

n irritability or aggression
n feeling low
n anxiety
n restlessness
n poor concentration
n increased appetite or weight gain
n urges to smoke (craving)
n night time awakening or sleep disturbance
n lowering of heart rate

Effects of too much nicotine

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.

!

4 Possible side-effects

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 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.
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 hives (urticaria)
n excessive sweating
n itching
n rash
n unusual weakness
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:
(less than 1 in 1,000 people are affected)
n difficulty in swallowing
n decreased feeling or sensitivity, especially in the mouth
n feeling of wanting to be sick (vomit)

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 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.

What the medicine looks like
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.

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. ®

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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