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NICORETTE NASAL SPRAY
Active substance(s): NICOTINE
NNS 10mg Leaflet
REPLACED COMP CODE
DIELINE / TECH DRAWING REFERENCE
PDD McNeil, HBG, SWE
July 28, 2017 14:38:00
are pregnant or breast-feeding” section.
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.
n if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation of
the oesophagus (passage between the mouth
n if you have liver or kidney disease.
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.
n if you have a respiratory disease, especially
n if you have diabetes – monitor your blood
sugar levels more often when starting to use
NICORETTE® Nasal Spray as you may find
your insulin or medication requirements alter.
n if you are taking other medicines such as
theophyl line, clozapine or ropinirole. Stopping
smoking or cutting down may require the dose
of these medicines to be adjusted.
➤If any of these applies, talk to your doctor,
nurse or pharmacist.
nasal spray solution
What you should know about nicorette
(10 ml nasal spray containing nicotine 10 mg/ml)
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 Nasal Spray is a nicotine
replacement therapy (NRT). It is used to relieve
withdrawal symptoms and reduce the cravings for
nicotine that you get when you try to stop
To help quit smoking you should also try to use a
behavioural support programme to increase your
chances of success.
What does nicorette® Nasal Spray 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 spray NICORETTE® Nasal Spray into
your nose, nicotine passes rapidly into your body
through the lining of your nose. 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.
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.
2 Before using this medicine
Do not use nicorette® Nasal Spray:
n if you have an allergy to nicotine or any of the
Talk to your doctor, nurse or
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
How to use nicorette® Nasal Spray
Follow the instructions and study the pictures
below to ensure that you hold the bottle at the
correct angle and use NICORETTE® Nasal Spray
Care should be taken not to spray the eyes whilst
administering NICORETTE® Nasal Spray
Remove the cap
Remove the protective cap by
squeezing the 2 side clips and pulling
off the cap as shown in the diagram.
If you are using NICORETTE® Nasal
Spray for the first time or if you have not used the
spray for 2-3 days you must first prime the spray
pump. (Please note priming reduces the number
of doses you may get from a bottle).
1 Point the spray safely away from you
and any other adults, children or pets
that are near you.
2 Place the nozzle between your first and
second finger with your thumb on the
bottom of the bottle.
3 Press several times firmly and quickly until a
fine spray appears (up to 7-8 strokes).
After Using the Spray
1 Replace the protective cap.
2 Keep the spray out of the reach of children and
3 The spray should be stored protected from
When to use nicorette® Nasal Spray
The dosage information for NICORETTE® Nasal
Spray follows. This shows when you should take
the nasal spray, the maximum number of sprays
you can have a day and how long you can
continue to use the spray for.
Please read the information carefully and then go
to the “How to stop smoking” section which
shows you how to give up smoking.
Adults and Children aged 12 years and
Adults and Children
One spray in each
12 years and over aged nostril up to twice an
hour to relieve cravings.
n Do not spray in each nostril more than twice in
n Do not use more than 64 sprays per day – this
is equivalent to 2 sprays in each nostril every
hour for 16 hours.
n Children aged 12 and up to 18 years should
not use for longer than 12 weeks in total
without asking for help and advice from a
doctor, nurse or pharmacist.
n Adults aged 18 years and over should not use
for longer than 9 months in total without asking
for help and advice from a doctor, nurse or
Using the Spray
1 Insert the spray tip into
one nostril, pointing the
top towards the back of
your nose. Press firmly
and quickly. Then, insert
the spray tip into your
other nostril and repeat
the process. See the
diagrams which show the
correct and incorrect way
of inserting the spray.
Children under 12 years
Do not give this product to children under 12
Priming the Spray
If you are pregnant or breast-feeding
If you are pregnant: ideally, you should try to
give up smoking without NRT. If you can’t
manage this, you can use NRT as the risks to
your baby are far less than smoking, however you
should talk to your doctor, nurse or pharmacist for
Products that are used intermittently, including
NICORETTE® Nasal Spray, 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: ideally, you should try to
give up smoking without NRT. 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
Breast-feed just before you use NICORETTE®
Nasal Spray to make sure 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
n Use NICORETTE® Nasal Spray whenever you
feel the urge to smoke. The frequency with
which you use the spray will depend on how
many cigarettes you smoked and how strong
they were. You can use one spray in each
nostril up to twice an hour. You may find you
n Each spray delivers 50 microlitres of solution,
which contains 0.5 mg of nicotine.
n The 10ml bottle contains enough solution to
deliver about 200 sprays.
n You may find that in the first few days of use the
spray may irritate your nose and make you
sneeze and your eyes water. If this occurs do
not drive or operate machinery until these
unwanted effects have stopped.
3 How and when to use this
Some of the ingredients can cause
n NICORETTE® Nasal Spray contains methyland propyl parahydroxybenzoate (E216 and
E218) which may cause allergic reactions
(this may happen after a few days).
second-hand smoke they would inhale if you
smoked. Tobacco smoke produces breathing and
other problems in babies and children.
How to stop smoking
Because smoking is an addiction you may find it
difficult to give up. From time to time you may still
have strong urges to smoke but if you follow
these recommendations, you have a good chance
If you find it hard to stop using NICORETTE®
Nasal Spray, you are worried that you will start
smoking again without it or you find it difficult to
reduce the amount of sprays you are using, talk to
your doctor, nurse or pharmacist. Remember
NICORETTE® Nasal Spray is not intended as a
substitute for smoking, it is an aid to give up.
If you feel that you need extra help or want to use
an additional NRT product, talk to your doctor,
nurse or pharmacist as they will be able to advise
turn over ➤
The idea is to stop smoking immediately and use
the nasal spray to relieve the cravings to smoke.
After achieving this you then stop using the spray.
The timescale is up to 12 weeks (3 months) in
Adults and children aged 12 years and
See the following diagram which shows the basic
step by step process. Make sure that you read
the instructions for each step in the information
Preparation 8 weeks 2 weeks 2 weeks Time taken
for each step
Step 3 Step 4
Step 1: Set a date to quit and stop smoking
Step 2: Use NICORETTE® Nasal Spray to
relieve your cravings to smoke for
8 weeks. See Dosage section to decide
how many sprays you are allowed to use
and how often you can use the nasal spray.
Step 3: Start reducing the number of sprays
you use over 2 weeks. By the end of two
weeks you should aim to have halved the
number of sprays you use each day.
Step 4: Cut the number to none at all over the
following 2 weeks.
➤In step 3 & 4 of the course you may find that
one spray to one nostril will help you to
begin to reduce the number of sprays you
need to use.
➤You should not use NICORETTE® Nasal
Spray continuously for longer than 3
➤You might feel a sudden craving to smoke
long after you have given up smoking and
stopped using NICORETTE® Nasal Spray.
Remember you can use NICORETTE® Nasal
Spray again if this should happen.
➤If you need to use this product for more
than 9 months in total, you should ask your
doctor, nurse or pharmacist for advice.
If you have used too much Nasal Spray
If you have used more than the recommended
dosage of NICORETTE® Nasal Spray or have
smoked whilst using NICORETTE® Nasal Spray,
you may experience nausea, 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.
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.
If a child has used or swallowed Nasal
➤ Contact a doctor or your nearest hospital
Accident and Emergency department
4 Possible side-effects
Like all medicines, NICORETTE® Nasal Spray
can have side-effects.
As many of the effects are due to nicotine, they
can also occur when nicotine is obtained by
Effects related to stopping smoking
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® Nasal
Spray before you are ready to reduce your nicotine
These effects include:
n irritability or aggression
n feeling low
n poor concentration
n increased appetite or weight gain
n urges to smoke (craving)
n night time awakening or sleep disturbance
n 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:
n feeling faint
n feeling sick (nausea)
Side-effects of nicorette® Nasal Spray
During the first 2 days of treatment, many people
experience nasal irritation such as sneezing,
running nose, watering eyes and cough. If you
continue to use the nasal spray, the severity of
these effects and how often they occur will reduce.
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® Nasal Spray and
contact a doctor immediately.
Very common side-effects:
(may affect more than 1 in 10 people):
n runny nose
(may affect up to 1 in 10 people):
n tingling or numbness of the hands and feet
n nose bleeds
n throat irritation
n feeling sick (nausea)
n sickness (vomiting)
n excessive sweating
n chest discomfort and pain
(may affect up to 1 in 100 people):
n abnormal dream
n allergic reactions (hypersensitivity)
n sudden reddening of the face and/or neck
n high blood pressure
n tiredness (fatigue)
n general feeling of discomfort or being unwell or
out of sorts (malaise)
Other side-effects can include:
n watery eyes
n fast heart rate/beat
n nasal discomfort
n throat discomfort and pain
n stomach discomfort
n redness of the skin
n hives (urticaria)
n unusual weakness
➤ When you stop smoking you may also develop
mouth ulcers. The reason why this happens is
➤ 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.
5 Storing and disposal
n Keep NICORETTE® Nasal Spray 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 Store NICORETTE® Nasal Spray protected
n Do not use NICORETTE® Nasal Spray after
the ‘Use before’ date shown on the carton or
n Dispose of NICORETTE® Nasal Spray
n Medicines should not be disposed of via
waste-water 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: Disodium phosphate,
sodium dihydrogen phosphate, sodium chloride,
citric acid, polysorbate 80, ß-ionone, methyl and
propyl parahydroxybenzoate (E216 and E218),
disodium edetate and water.
What the medicine looks like
NICORETTE® Nasal Spray consists of a glass
bottle of solution, attached to a pump spray unit
designed to be put into your nose. A protective
cap which covers the nozzle is also supplied.
Who makes nicorette® Nasal Spray?
The Product Licence holder is McNeil Products
Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg,
This leaflet was revised in July 2017. ©
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.