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NICORETTE QUICKMIST 1MG/SPRAY MOUTHSPRAY

Active substance(s): NICOTINE / NICOTINE / NICOTINE

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Brand: Nicorette
Product: Ons 1mg BRAND
Mint Leaflet
Component Code: NICORETTE
651540
PRODUCT
Version: LKL-h
Ons 1mg Mint Leaflet
COMPONENT CODE
Dimensions: 558 x 651540
179
Font size: 10 pt REPLACED COMP CODE

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-h

651397

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020038

558x179mm

10 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

June 21, 2017 14:35:51

651540

1 What this medicine is for
QuickMist 1mg/spray mouthspray
nicotine
What should you know about
nicorette® QuickMist mouthspray
(nicotine 1 mg per spray)
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.

QuickMist 1mg/spray mouthspray
PACKAGE LEAFLET:
INFORMATION FOR THE USER
651540

NICORETTE® QuickMist 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®
mouthspray to achieve this by using it to
completely replace all your cigarettes.
However NICORETTE® mouthspray 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 and 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.
What does NICORETTE®
QuickMist do?
When you stop smoking 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 QuickMist,
nicotine passes rapidly 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.
For the best effect, ensure that you use
NICORETTE® QuickMist correctly – see
“How to Use NICORETTE® QuickMist.”
Benefits you can get from using NRT
instead of smoking
For the best effect, ensure that you use
nicorette mouthspray correctly – see
“How to Use NICORETTE® QuickMist.”
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 diseases 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
the 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.

®

2 Before using this medicine
X

Do not use nicorette® QuickMist:

 if you have an allergy to nicotine or
any of the other ingredients.
 if you are under 12 years of age.
!

!

Talk to your doctor, nurse or
pharmacist…

 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,
chest pain, 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

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® mouthspray 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.

starting to use NICORETTE
QuickMist 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 apply, talk to your
doctor, nurse or pharmacist.
®

Important information about
some of the ingredients

NICORETTE® QuickMist contains small
amounts of ethanol (alcohol), less than
100 mg per spray.
!

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® mouthspray
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.

i

i

TO UNLOCK NOZZLE

a

i

b

c

Opening nicorette® QuickMist

b

1. Use your thumb to slide down the
buttond (a) until it can be pushed
lightly
f
e
inwards (b). Do not push
too hard. e
2. While pushing in, slide upwards (c) to
unlock the top of the dispenser. Then
release the button.

button

Priming nicorette® QuickMist

If you are using NICORETTE® QuickMist
for the first time or if you have not used
the spray for 2 days, you must first prime
the spray pump.
 Point the spray safely away from you
and any other adults, children or pets
that are near you.
 Press the top of the QuickMist with
your index finger 3 times until a fine
spray appears.
Note: priming reduces the number
of sprays you may get from
NICORETTE® QuickMist.

3 How and when to use
this medicine

Follow the instructions and study the
pictures below to ensure you use
NICORETTE® QuickMist correctly.
Care should be taken not to spray the
eyes whilst administering the spray.

i

spray
nozzle

How to use nicorette® QuickMist
3. Point the spray nozzle towards your
open mouth and hold it as close to
your mouth as possible.
4. Press the top of the dispenser to
release one spray into your mouth. Do
not inhale while spraying to avoid
getting
a spray down your throat. For
c for a few
b
best results, do not bswallow
seconds after spraying.

TO LOCK NOZZLE

d

e

f

e

!

!

i

How to close nicorette QuickMist
®

5. Slide the button down (d) until it can
be pushed inwards (e).
6. While pushing in, slide the top of the
dispenser downwards (f). Release the
button. The QuickMist spray is now
closed. Close the QuickMist spray every
time after use to prevent use of the spray
by children and accidental spraying.
Care should be taken not to spray
the eyes whilst administering the
mouthspray. If you get spray in your
eye(s), rinse thoroughly with water.
Do not eat or drink when
administering the mouthspray.

When to use nicorette® QuickMist

If you are able to stop smoking you
should use the mouthspray, 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 sprays 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 mouthspray. There are
toxins in cigarettes that can cause harm
to your body.
NICORETTE® QuickMist 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 mouthspray on
those occasions when you can’t or don’t
want to smoke e.g. Social situations

turn over 

651540

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

i
i

!

If you have used more than the
recommended amount of NICORETTE®
QuickMist or have smoked whilst using
NICORETTE® QuickMist, 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.

Below is the dosage information
for nicorette® mouthspray
Children under 12 years
Do not give this product to children
under 12 years.

i

Adults and children aged
12 years and over

Age
Dosage
Adults and  It is important to use enough
children nicotine spray to control
aged 12 cravings.
years and  Use one spray first when you
over would normally smoke a
cigarette or have cravings
to smoke.

 If your cravings do not
disappear within a few
minutes use a second spray.

 If 2 sprays are required to
control cravings, future
doses may be delivered
as 2 consecutive sprays.

 Most smokers will require
1 - 2 sprays every 30
minutes to 1 hour.

 Do not use more than 2 sprays
per dose or 4 sprays every
hour. Do not use more than
64 sprays per day – this
is equivalent to 4 sprays
per hour for 16 hours.
 Do not use more than 2 sprays per
dose or more than 64 sprays per day
– this is equivalent to 4 sprays every
hour for 16 hours.

If you have used too much
nicorette® QuickMist

!

If a child has used or swallowed
nicorette® QuickMist
➤Contact a doctor or your nearest

hospital Accident and Emergency
department immediately if a child
under 12 years uses or swallows this
medicine. 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®
QuickMist 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®
QuickMist before you are ready to

reduce your nicotine intake.
i

These effects include:

 irritability or aggression
 impatient or frustrated
 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
 constipation
 bleeding gums
 dizziness or light-headedness
 sore throat, stuffy or runny nose
➤When you stop smoking you may also
develop mouth ulcers, cough and/or
symptoms of a common cold.
The reason why this happens is
unknown.
Side-effects for nicorette®
QuickMist
If you notice any of the following; fast
heart rate/beat, abnormal beating of the
heart, 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 or dizziness)
stop taking NICORETTE® QuickMist
and contact a doctor immediately.
Very common side-effects:
(may affect more than 1 in 10 people):
 hiccups (these are particularly
common)
 throat irritation

 headache
 feeling sick (nausea)
 cough
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
 toothache
 stomach pain or discomfort
 excessive gas or wind
 vomiting
 dry mouth
 indigestion
 diarrhoea
 tiredness (fatigue)
 sore and inflamed mouth
 increased salivation
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
 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)
 dry skin
 muscle and bone pain
 mouth and throat pain
 sneezing
 runny nose
 blocked nose
 inflammation of the gums
Rare side-effects
(may affect up to 1 in 1,000 people):
 difficulty in swallowing
 decreased feeling of sensitivity
especially in the mouth
 feeling or wanting to be sick (vomit)
The following side-effects may also
occur:
Other side-effects can include:
 blurred vison, watery eyes
 dry throat, lip pain
 stomach discomfort
 redness of the skin
 muscle tightness
➤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.

You can also report side effects
directly in Malta via:
ADR Reporting at:
www.medicinesauthority.gov.mt/
adrportal

5 Storing and disposal

 Keep NICORETTE® QuickMist 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® QuickMist
after the ’Use before’ date shown on
the back on the pack.
 Dispose of used NICORETTE®
QuickMist sensibly and 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.
Other ingredients are: propylene glycol,
anhydrous ethanol, trometamol,
poloxamer 407, glycerol, sodium
hydrogen carbonate, levomenthol, mint
flavour, cooling flavour, sucralose,
acesulfame potassium, hydrochloric
acid, purified water.
What the medicine looks like
NICORETTE® QuickMist consists of a
plastic bottle of solution held in a
dispenser with a mechanical spray
pump.

Each bottle contains 13.2 ml of solution
which provides at least 150 sprays, each
spray containing 1mg nicotine.
NICORETTE® QuickMist is supplied in
packs of either 1 or 2 dispensers.
Not all pack sizes may be marketed.
Who makes nicorette®
QuickMist?
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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