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NICORETTE 15MG INHALATOR

Active substance(s): NICOTINE / NICOTINE / NICOTINE

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Brand: Nicorette BRAND
Product: Inhaler 15mg
Leaflet
NICORETTE
PRODUCT
Component code:Inhaler
651536
15mg Leaflet
COMPONENT CODE
Version number: LKL-g
651536

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-g

REPLACED COMP CODE

651379

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020025

560x180mm

9 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 30, 2017 08:41:46

making a quit attempt a behavioural support programme will
increase your chances of success.

What does nicorette® inhalator do?
15mg inhalator
nicotine
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

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® 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”.

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.

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.

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,

n 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.

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,
- 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

n 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.

2 Before using this medicine
X

Do not use nicorette® inhalator:
n if you have an allergy to nicotine or any of the other
ingredients.

unused cartridges in the pack out of the reach and sight of
children.
!

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.

n If you are a child under 12 years of age.
!

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.

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.

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.

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.

n 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 are breast-feeding:

n if you have liver or kidney disease.

1) Firstly, you should try to give up smoking without NRT.

n 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.

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® inhalator to
ensure that the baby gets the smallest amount of nicotine
possible.

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.

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 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.
n 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 adjusted.
If any of these apply, 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

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.

3 How and when to use this medicine
i

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.

i

651536

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.
i

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.

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
relief.
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.

When to use the inhalator

i

Below is the dosage information for
nicorette® inhalator.
Age

Dose

Adults and children
aged 12 years and
over

As needed up to a
maximum of 6
cartridges per day

n Do not use more than 6 cartridges per day.
n 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.
turn over ➤

651536
!

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.
n 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
n 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.
!

These effects include:
n irritability or aggression

!

n poor concentration

n taste disturbance or loss of taste

Rare side-effects:

n increased appetite or weight gain

n tingling or numbness of the hands and feet

(may affect up to 1 in 1,000 people):

n urges to smoke (craving)

n blocked nose

n difficulty in swallowing

n night time awakening or sleep disturbance

n stomach pain or discomfort

n decreased feeling or sensitivity, especially in the mouth

n lowering of heart rate

n diarrhoea

n feeling of wanting to be sick (vomit)

Effects of too much nicotine

n dry mouth

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.

n indigestion

Other side-effects can include:

n excessive gas or wind

These effects include:

n sickness (vomiting)

n feeling faint

n tiredness (fatigue)

n feeling sick (nausea)

Uncommon side-effects:

n headache

n increased salivation

(may affect up to 1 in 100 people):

Side-effects for nicorette inhalator
®

n abnormal dream

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 using
NICORETTE® inhalator and contact a doctor immediately.

n sudden reddening of the face and/or neck

Very common side-effects:

n throat tightness

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 sneezing

(may affect more than 1 in 10 people):

n burping (belching)

n headache

n swollen, red, sore tongue

n cough

n mouth ulcers or blisters

n throat irritation

n numbness or tingling of the mouth

n (feeling sick) nausea

n hives (urticaria)

n sore and inflamed mouth

n excessive sweating

n hiccups

n itching

Common side-effects:

n rash

(may affect up to 1 in 10 people):

n feeling low

n allergic reactions (hypersensitivity)

n anxiety

n burning sensation in the mouth

n restlessness

n dizziness

n pain in jaw
n unusual weakness
n chest discomfort and pain
n general feeling of discomfort or being unwell or out of
sorts (malaise)

n blurred vision, watery eyes
n stomach discomfort
n redness of the skin
n dry throat, lip pain
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 Cleaning, storing and disposal
Cleaning the inhalator

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

Storing the inhalator and cartridges
n 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.
n Do not store above 25°C.

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

Disposal
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, 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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