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NICORETTE COOLS 4MG LOZENGE

Active substance(s): NICOTINE RESINATE

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651388

Please read this leaflet carefully
nicorette®
before you start using this medicine.
cools
2 mg and 4 mg Lozenge
It provides useful information on
nicotine
how to use it safely. Keep the leaflet,
compressed lozenge
you might need it again.
What you should know about
If you think you are having
nicorette® cools lozenge
side-effects, have any questions or
®
are not sure about anything please
nicorette
ask your doctor, nurse or pharmacist.
cools 2 mg Lozenge
(2 mg nicotine compressed
1 What this medicine
lozenge)
is for
nicorette®
Nicorette® cools lozenge is a
cools 4 mg Lozenge
nicotine replacement therapy (NRT).
(4 mg nicotine compressed
It is used to relieve and /or prevent
lozenge)
withdrawal symptoms and reduce
the cravings you get when you try to
stop smoking or when cutting down
the number of cigarettes you smoke.

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

651388

Nicorette® cools lozenge 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®
cools lozenge to achieve this by
using it to completely replace all
your cigarettes.
However Nicorette cools lozenge
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.

What does nicorette® cools
lozenge 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 use nicorette® cools
lozenge, nicotine is released and
passes into your body through the
lining of your mouth. The nicotine
released is sufficient to relieve the
unpleasant nicotine withdrawal
symptoms. It will also help to stop
your craving to smoke but will not
give you the “buzz” you get from
smoking a cigarette.

Benefits you can get from using NRT
instead of smoking

2 Before using this
medicine

For the best effect, ensure that you
use nicorette cools lozenge correctly
– see “How to Use Nicorette® cools
lozenge”.

X Do

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 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.

not use nicorette® cools
lozenge:

!

 if you have an allergy to nicotine
or any of the other ingredients.
 if you are a child under 12 years
of age.
Nicorette
Nova - Leaflet Icons

Talk to your doctor, nurse or
pharmacist…
 If you are pregnant or breastfeeding – 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 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 cools lozenge as you may
find your insulin or medication
requirements alter.
 if you are taking any other
medicines such as theophylline,
clozapine or ropinirole. Stopping
smoking may require the dose of
these medicines to be adjusted.
➤ If any of these applies, talk to
your doctor, nurse or pharmacist.

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® cools lozenge,
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®
cools lozenge 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.

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3 How and when to use
this medicine
i

How to use nicorette® cools

lozenge

Place the lozenge in the mouth.
Allow it to slowly dissolve. This will
release nicotine, which you will
absorb through the lining of your
mouth. Nicorette® cools lozenge
should NOT be chewed or
swallowed.
The number of lozenges you use
each day will depend on how many
cigarettes you smoked and how
strong they were. See dosing
information over the page to find
out the dose you should use.
i

When to use nicorette®

cools lozenge

 If you smoke 20 or less
cigarettes a day, the 2 mg nicotine
lozenge will help relieve your
cravings.
 The 4 mg lozenge should be used
by people who smoke more than
20 cigarettes a day.
If you are able to stop smoking you
should use the lozenge, 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
lozenges 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

Op

651388

cigarettes as possible with the
lozenge. There are toxins in
cigarettes that can cause harm to
your body. Nicorette® cools lozenge
provides a safer alternative to
smoking, for both you and those
around you. Reducing the amount 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 the lozenge 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.

i

years and over

i

Children under 12 years
Do not give this product to children
under 12 years.

Age

Dosage of lozenge

Adults and
children aged
12 years
and over

One lozenge to
be taken as
required to
relieve cravings.

4 Possible side-effects
Like all medicines, nicorette® cools
lozenge 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® cools lozenge
before you are ready to reduce your
nicotine intake.

• Most people take between 8 to 12
lozenges per day.
• Do not take more than 15 lozenges
per day.
• Do not exceed the stated dose.
!

If you have used too much
nicorette® cools lozenge

If you have used more than the
recommended amount of nicorette®
cools lozenge 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.

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® cools lozenge but are
finding this difficult you should
contact your doctor, nurse or
pharmacist for advice.
Below is the dosage information for
the nicorette® cools lozenge. This
shows the number of lozenges 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.

Nicotine ingestion by a child may
result in severe poisoning.

Adults and children aged 12

!

If a child has used or
swallowed a nicorette® cools
lozenge
➤ 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.

!

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

Side-effects for nicorette®
cools lozenge

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® cools lozenge and
contact a doctor immediately.
Very common side-effects:
(may affect more than 1 in 10 people):
 headache
 cough
 feeling sick (nausea)
 throat irritation
 hiccups
 sore mouth or throat
Common side-effects:
may affect up to 1 in 10 people):
 allergic reactions (hypersensitivity)
 burning sensation in the mouth
 dizziness
 taste disturbance or loss of taste
 tingling or numbness of the hands
and feet
 stomach pain or discomfort
 diarrhoea
 dry mouth
 indigestion
 excessive gas or wind
 increased salivation
 sore and inflamed mouth
 tiredness (fatigue)
 sickness (vomiting)
Uncommon side-effects:
(may affect up to 1 in 100 people):
 abnormal dream

 chest palpitations, fast heart rate/beat
 sudden reddening of the face and/
or next
 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
 excessive sweating
 itching
 rash
 hives (urticaria)
 unusual weakness
 chest discomfort and pain
 jaw-muscle ache
 general feeling of discomfort or
being unwell or out of sorts
(malaise)
Rare side-effects:
(may affect up to 1 in 1,000 people):
 allergic reactions (swelling of the
mouth, lips, throat or tongue,
itching of the skin, swelling of
skin, ulceration and inflammation
of the lining of the mouth)
 difficulty in swallowing
 decreased feeling of sensitivity,
especially in the mouth
 feeling of wanting to be sick (vomit)
Very rare side-effects:
(may affect up to 1 in 10,000 people):

 abnormal beating of the heart
Other side-effects can include:
 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 sideeffects not listed in this leaflet.
You can also report side-effects
directly via the Yellow Card
Scheme at: www.mhra.gov.uk/
yellowcard
By reporting side-effects you can
help provide more information on
the safety of this medicine.

5 Storing and disposal
 Keep nicorette® cools lozenge
out of the sight and reach of
children and animals. Nicotine in
high doses can be very dangerous
and sometimes fatal if taken by
small children.
 Nicorette® cools lozenge does
not require any special storage
conditions.
 Do not use the product after the

’Use before’ date on the bottle,
box or blister strip.
 Dispose of lozenges sensibly away
from children and animals.
Medicines should not be disposed
of via wastewater 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 is nicotine.
Each lozenge contains 2 or 4
milligrams of nicotine (as nicotine
resinate).
Other ingredients are:
Mannitol (E421), Xanthan gum
(E415), Winterfresh Flavour, Sodium
carbonate anhydrous, Sucralose (E955),
Acesulfame potassium (E950),
Magnesium stearate (E470b),
Hypromellose (Methocel E3),
Titanium dioxide (E171), Sepifilm
gloss, Polysorbate 80.

What the medicine looks like

Nicorette cools 2 mg lozenge is an
oval, white to off-white lozenge
imprinted with a “n” on one side
and “2” on the other side.
®

Nicorette® cools 4 mg lozenge is an
oval, white to off-white lozenge
imprinted with a “n” on one side
and “4” on the other side.
ack types and pack sizes:
P
Loose-fill packed in a plastic bottle

(’’Flip pack’’) containing 20 lozenges
and supplied in packs of 20 (1x20) or
80 (4x20) lozenges.
Blister packed in sheets of 12 and
contained in a cardboard box supplied
in packs of 24 (2x12) lozenges.
Not all pack types and pack sizes may
be marketed.

Who makes nicorette® cools
lozenge?

The Product Licence holder is McNeil
Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
The manufacturer is McNeil AB,
Helsingborg, Sweden.
This leaflet was prepared in
December 2015. ©

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 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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