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Active substance(s): NICOTINE

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nasal spray
nasal spray solution
What you should know about nicorette®
Nasal Spray
(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 smoking.
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
other ingredients.
! 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.
n 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.
n if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation
of the oesophagus (passage between the mouth
and stomach).
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
theophylline, 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.
! Some of the ingredients can cause
n Nicorette Nasal Spray contains methyl- and
propyl parahydroxybenzoate (E216 and E218)
which may cause allergic reactions (this may
happen after a few days).
! 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 advice.
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
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
i 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
Remove the cap
Remove the protective cap by squeezing
the 2 side clips and pulling off the cap as
shown in the diagram.
Priming the Spray
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).

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.
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 light.
i 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.
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 need less.
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.
i Children under 12 years
Do not give this product to children under 12 years.
i Adults and Children aged 12 years
and over
Adults and Children
One spray in each nostril up
aged 12 years and over to twice an hour to relieve

• Do not spray in each nostril more than twice in one
• Do not use more than 64 sprays per day – this is
equivalent to 2 sprays in each nostril every hour for
16 hours.
• 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.
• 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 pharmacist.
i 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 of
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
i Stopping Immediately
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 total.
i Adults and children aged
12 years and over
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 which
Step 1

8 weeks 2 weeks 2 weeks Time taken
(2 months)
for each step
Step 2

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 on page 14 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 months.
➤ 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
➤ 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.
! If a child has used or swallowed Nasal Spray
➤ 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 Nasal Spray can have
As many of the effects are due to nicotine, they
can also occur when nicotine is obtained by

turn over


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
Nasal Spray before you are ready to reduce your
nicotine intake.
! These effects include:
n irritability or aggression
n feeling low
n anxiety
n restlessness
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)
n headache
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
Very common side-effects:
(more than 1 in every 10 people are affected)
n runny nose
n sneezing
n watery eyes
n nosebleeds
Common side-effects:
(less than 1 in every 10 people are affected)
n headache
n dizziness
n cough
n stomach discomfort
n feeling sick (nausea)
n sickness (vomiting)
Uncommon side-effects:
(less than 1 in every 100 people are affected)
n chest palpitations
Very rare side-effects:
(less than 1 in 10,000 people are affected)
n abnormal beating of the heart
➤ If you notice these or any other unwanted effects
not listed in this leaflet tell your doctor, nurse or
➤ When you stop smoking you may also develop
mouth ulcers. The reason why this happens is

5 Storing and disposal

n Keep Nicorette Nasal Spray 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.
n Store Nicorette Nasal Spray protected from light.
n Do not use Nicorette Nasal Spray after the ‘Use
before’ date shown on the carton or label.
n Dispose of Nicorette Nasal Spray sensibly.
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 December 2011. ©
Information about Nicorette ActiveStop
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.
Call 0800 244 838 for information

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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.