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Active substance(s): NICOTINE

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BRAND: Nicorette Inhaler
DATE: 2012-08-16/LKL-a
ARTICLE No: 651264
DESCRIPTION: Leaflet Inhaler 15mg
REPLACES No: 650941
SIZE: 280x180 mm -- 2 pages




August 16, 2012 09:05:17


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
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 cigarettes.
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 nicotine.

2 Before using this medicine
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, 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
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.

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.

3 How and when to use this

Follow the instructions below.

Setting up the inhalator

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

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.

How to use nicorette® inhalator


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.

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 nicotine.

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 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 the inhalator
but are finding this difficult you should contact
your doctor, nurse or pharmacist for advice.


Age Dose
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.

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.


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

 night time awakening or sleep disturbance
 lowering of heart rate

Below is the dosage information
for nicorette inhalator.

These effects include:

 irritability or aggression
 feeling low
 anxiety
 restlessness
 poor concentration
 increased appetite or weight gain
 urges to smoke (craving)

Effects of too much nicotine
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)
 headache

Side-effects for nicorette®
Very common side-effects

(more than 1 in every 10 people are affected)
 headache
 cough
 irritation of the mouth or throat

Common side-effects:

(less than 1 in every 10 people are affected)
 dizziness
 nasal congestion
 stomach discomfort
 hiccups
 feeling sick (nausea)
 sickness (vomiting)

Uncommon side-effects:

(less than 1 in every 100 people are affected)
 chest palpitations

Very rare side-effects:

(less than 1 in 10,000 people are affected)
 abnormal beating of the heart
➤If you notice these or any other unwanted
effects not listed in this leaflet tell your
doctor, nurse or pharmacist.
Also you can help to make sure medicines
remain as safe as possible by reporting any
unwanted side-effects via the internet at yellowcard; alternatively
you can call Freephone 0808 100 3352
(available between 10am – 2pm Monday to
Friday) or fill in the paper form available
from your local pharmacy.
➤When you stop smoking you may also
develop mouth ulcers. The reason why this
happens is unknown.

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 reach
and sight 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
inserted into the mouthpiece within 48
hours even if it has not been used.


Dispose of your used inhalator cartridges
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 August 2012. ©

Information about nicorette®
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 and a mobile
Call 0800 244 838
for information.

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.