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NICORETTE COOLS 2MG LOZENGE

Active substance(s): NICOTINE RESINATE / NICOTINE RESINATE / NICOTINE RESINATE

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Brand: Nicorette
NICORETTE CM LeafletSPRUCE
Product: Loz 2/4mg
LOZ 2/4mg CM Leaflet
Component Code:
651539
LKL-e
651539
Version: LKL-e651388
Dimensions: 558
x 179
GB
10 pt
CH0200038
558x179
Font size: 10 pt
BRAND

DESIGN

COLOR

PRODUCT

COMPONENT CODE

BLACK

VERSION

REPLACED COMP CODE
MARKET

PMS 355

DIELINE / TECH DRAWING REFERENCE

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 9, 2017 07:11:16

cools
2 mg and 4 mg Lozenge
nicotine
compressed lozenge
What you should know about
nicorette® cools lozenge
nicorette®
cools 2 mg Lozenge
(2 mg nicotine compressed
lozenge)
nicorette®
cools 4 mg Lozenge
(4 mg nicotine compressed
lozenge)

PACKAGE LEAFLET:
INFORMATION FOR THE USER
651539

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 this medicine is for
NICORETTE® cools lozenge 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® cools lozenge can also be
used when you are pregnant or breastfeeding 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®
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,

„ 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.

- 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.

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

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.

2 Before using this medicine
X

Do 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.

!

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,

!

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.

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 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.
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.

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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

i

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

651539

i

Adults and children aged 12
years and over
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)

„ 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.

!

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.
Nicotine ingestion by a child may
result in severe poisoning.

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.
!

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; 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®
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
„ 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
„ 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):
„ difficulty in swallowing
„ decreased feeling of sensitivity,
especially in the mouth
„
feeling of wanting to be sick (vomit)

Other side-effects can include:
„ 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.
Pack types and pack sizes:
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
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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