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Active substance(s): NICOTINE / NICOTINE

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smoking a cigarette.
Benefits you can get from using NRT instead
of smoking
For the best effect, ensure that you use
nicorette inhalator correctly – see “How to Use
NICORETTE® inhalator”.
The benefits of stopping smoking clearly
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.

15mg inhalator
inhalation cartridges
What should you know about
nicorette® 15mg inhalator

(nicotine 15 mg per cartridge)
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® inhalator 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.
Ideally you should always aim to stop smoking.
You can use NICORETTE® inhalator to achieve
this by using it to completely replace all your
However NICORETTE® inhalator 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® inhalator 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
When you use NICORETTE® inhalator, air is
drawn through the inhalator and nicotine is
released. The nicotine is absorbed into your
body through the lining of your mouth. This
relieves the unpleasant withdrawal symptoms.
It will also help to stop your craving to smoke,
but will not give you the ’’buzz’’ you get from

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 inhalator 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 or cutting down may
require the dose of these medicines to be
If any of these applies, talk to your doctor,
nurse or pharmacist.
This product contains small cartridges which
could be a choking hazard if a child attempts to
swallow one. Keep any unused cartridges in the
pack out of the reach and sight of children.

X Do not use nicorette® inhalator:
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

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 a long term throat disease or
difficulty breathing due to bronchitis,
emphysema or asthma. NICORETTE® inhalator
may not be suitable for you to use and you
may be advised to use a different type of NRT.
if you have an overactive thyroid gland or


Changing a cartridge

1 Open the mouthpiece as in step 3 of Setting
up the inhalator. Pull out the cartridge and
dispose of it safely.
2 Put a new cartridge into the inhalator as in
steps 4-6 of Setting up the inhalator.

Dosage and temperature

NICORETTE® inhalator works best at room
temperature and it is best not to use the
inhalator in the cold.
In cold surroundings (below 15°C or 59°F) you
may have to inhale more often to get the same
amount of nicotine as when using the inhalator
at room temperature. When you are in
surroundings above 30°C or 86°F, you should
inhale less often to avoid taking in too much

3 How and when to use this

How to use nicorette® inhalator

Follow the instructions below.

Setting up the inhalator

1 Take the sealed plastic tray from the box.
Peel back the foil.

Special information about using
the inhalator
Using the inhalator

1 Inhale using the inhalator, either deeply or
shallow puffs. Choose the way that suits
you. Either way, your body will receive the
amount of nicotine required to give craving
You may find it takes more effort than
inhaling from a cigarette, but the amount of
nicotine you absorb through the lining of
your mouth is the same whether you take
deep or shallow puffs.
2 It is up to you how many inhalations (puffs)
you take, how often you take them and for
how long.
3 Each cartridge will provide you with about
40 minutes of intense use. You can divide this
time how you like. For example, you could
use a cartridge for four 10 minute inhalation
periods. Or you could use a cartridge for 10
minutes on waking and then for six periods
of five minutes later on in the day.
Once the cartridge is used up, you will need
to change it.

If you are pregnant or

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® inhalator 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 se NICORETTE®
inhalator 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.

2 Before using this medicine


2 Take the plastic mouthpiece from the box.
3 Twist the two sections of the mouthpiece
until the two marks line up. Then pull the
mouthpiece apart.
4 Take a cartridge from the tray. Push the
cartridge firmly into the bottom of the
mouthpiece until the seal breaks.
5 Put the top section on the mouthpiece,
lining up the two marks. Push together
firmly to break the cartridge seal.
6 Twist to lock.


When to use the inhalator

If you are able to stop smoking you should use
the inhalator, when needed, in place of
cigarettes. As soon you can (this could be after a
number of weeks or months) you should reduce


the number of cartridges 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 inhalator.
There are toxins in cigarettes that can cause harm
to your body. NICORETTE® inhalator 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 inhalator 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
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 the inhalator
but are finding this difficult you should contact
your doctor, nurse or pharmacist for advice.

If you have used nicorette®
inhalator too much

If you have used more than the recommended
number of cartridges, 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.

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® inhalator cartridges before you
are ready to reduce your nicotine intake.

If a child uses an inhalator or
swallows a cartridge

 Contact a doctor or your nearest hospital
Accident and Emergency department
immediately if a child under 12 years uses
your inhalator, or chews, sucks or swallows a
cartridge. Take this leaflet and the pack with
Nicotine inhalation or ingestion by a child may
result in severe poisoning.

4 Possible side-effects

Like all medicines, NICORETTE inhalator can
have side-effects. As many of the effects are

These effects include:

irritability or aggression
feeling low
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

Below is the dosage information
for nicorette® inhalator.

Adults and children
As needed up to a
aged 12 years and
maximum of 6
cartridges per day
 Do not use more than 6 cartridges per day.
 The frequency with which you use the cartridges
and the length of time it lasts will depend on
how many cigarettes you smoked and how
strong they were.

due to nicotine, they can also occur when
nicotine is obtained by smoking.

It is possible to inhale too much nicotine if you
use the inhalator in very warm surroundings.
You may also get these effects if you are not
used to inhaling tobacco smoke.

These effects include:
feeling faint
feeling sick (nausea)

Side-effects for nicorette®

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 using NICORETTE®
inhalator and contact a doctor immediately.

Very common side-effects:
(may affect more than 1 in 10 people):
throat irritation
(feeling sick) nausea
sore and inflamed mouth

Common side-effects:

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

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 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
throat tightness
burping (belching)
swollen, red, sore tongue
mouth ulcers or blisters
numbness or tingling of the mouth
hives (urticaria)
excessive sweating
pain in jaw
unusual weakness
chest discomfort and pain
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 or 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:

a serious allergic reactions which cause
difficulty in breathing or dizziness, swelling
of the face or throat
blurred vision, watery eyes
stomach discomfort
redness of the skin
dry throat, lip pain
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:;
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

5 Cleaning, storing and disposal
Cleaning the inhalator

Clean the empty mouthpiece several times a
week by rinsing it in water.

Storing the inhalator and

Keep NICORETTE® inhalator 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.
Do not store above 25°C.
Do not use NICORETTE® inhalator after the
’Use before’ date shown on the carton.
Dispose of any cartridge that has been inser
ted into the mouthpiece within 48 hours
even if it has not been used.


Dispose of your used inhalator cartridges safely.
When a cartridge is used up, it is very
important that you dispose of the empty
cartridge carefully as it still contains some
nicotine fixed to the plug. This nicotine is not
available for inhalation but could be harmful
to children or pets if swallowed or sucked.
You can return the empty cartridge to the
foil tray then dispose of all the empty
cartridges with your household rubbish.

6 Further information

What’s in this medicine?
The active ingredient is Nicotine.
Other ingredients are: Menthol.

What the medicine looks like

NICORETTE® inhalator consists of a plastic
mouthpiece into which you insert a tube-like
cartridge containing 15 mg of nicotine, the
active ingredient, held in a porous plug.
The plug also contains menthol to give the
nicotine a slight minty flavour.
Pack sizes: 4, 20 or 36.
Each pack contains a plastic tray sealed with foil
containing 4, 20 or 36 cartridges and a plastic
mouthpiece. Not all pack sizes may be marketed.

Who makes nicorette® inhalator?
The Product Licence holder is McNeil Products
Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg,
This leaflet was prepared in December 2015. ©

Information about nicorette®

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
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.