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NICORETTE MICROTAB

Active substance(s): NICOTINE BETA-CYCLODEXTRIN COMPLEX

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Brand: Nicorette
BRAND
NICORETTE
Product: Microtab 2mg
leaflet
PRODUCT
Component code: 651537
Microtab 2mg Leaflet
Version number: LKL-j
COMPONENT CODE
Text font: 9 pt
651537

DESIGN

SPRUCE

COLOR

BLACK

VERSION

LKL-j

REPLACED COMP CODE

651396

PMS 355

MARKET

GB

DIELINE / TECH DRAWING REFERENCE

CH020026

9 pt

ADDITIONAL
INFORMATION

PDD McNeil, HBG, SWE

July 28, 2017 15:05:20

651537

microtab 2mg sublingual tablet
nicotine
What you should know about
nicorette® 2mg sublingual tablet
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® Microtab 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, or when you are
cutting down the number of cigarettes you
smoke while trying to stop smoking.
To help cut down or quit smoking you
should also try to use a behavioural support
programme to increase your chances of
success.
IMPORTANT: NICORETTE® Microtab is a
sublingual tablet which means it must
be dissolved under the tongue and NOT
swallowed or chewed.
What does nicorette® microtab 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® Microtab,
nicotine is released and passes into your
body through the lining of your mouth. 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
X Do not use nicorette® microtab:
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, 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 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 diabetes – monitor your
blood sugar levels more often when
starting to use NICORETTE® Microtab
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 apply talk to your
doctor, nurse or pharmacist.
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® Microtab, 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 advice.
Breast-feed just before you use
NICORETTE® Microtab 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
medicine
How to use nicorette microtab
Place the microtab under your tongue.
Allow it to slowly dissolve (about 30
minutes). This will release nicotine, which
you will absorb through the lining of your
mouth. NICORETTE® Microtab should
NOT be chewed or swallowed.
When to use the nicorette® microtab
Below is the dosage information for the
NICORETTE® Microtabs. This shows the
number of microtabs you should be taking,
when you should take them, how you
should take them and the maximum amount
of time you should be using Nicotine
®

Replacement Therapy (NRT) for.
Please read the information carefully and
then go to the “How to stop smoking: your
choice” section, which will help you decide
which method to use to give up smoking.
n The number of NICORETTE® Microtabs
you use each day will depend on how
many cigarettes you smoked and how
strong they were. See dosing information
over the page to find out the dose you
should use.
i Children under 12 years
Do not give this product to children under
12 years.
i Adults and Children 12 years and over
Number of Cigarettes
Dose of Microtabs
you smoke per day
20 cigarettes or fewer One microtab to be
taken every hour.
More than 20 cigarettes Two microtabs to be
taken every hour.
n Most people take between 8 to 24
microtabs per day.
n Do not take more than 40 microtabs per day.
Do not exceed stated dose.
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 more than 9 months in total without
asking for help and advice from a doctor,
nurse or pharmacist.

i

i

How to stop smoking: your choice
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 quitting.
Some people may find it easier to set a
date to quit and stop smoking
immediately.
Others who are unable or not ready to stop
smoking abruptly, may benefit from
gradually reducing the number of
cigarettes they smoke each day until they
feel ready to stop completely.
If you are an adult you can follow either one
of these options. However children should
follow the guide to stopping immediately as
the recommended duration of nicotine
replacement therapy in children is 12
weeks maximum. The only time children
should stop gradually is if they are having a
problem stopping immediately and they
should talk to their doctor, nurse or
pharmacist beforehand.
If you find it hard to stop using
NICORETTE® Microtabs, you are worried
that you will start smoking again without
them or you find it difficult to reduce the
number of NICORETTE® Microtabs you
are using, talk to your doctor, nurse or
pharmacist. Remember NICORETTE®
Microtabs are not intended as a substitute
for smoking, they are an aid to give up.
Use one of the two options which follow.
Stopping Immediately
The idea is to stop smoking immediately

i

and use the microtabs to relieve the
cravings to smoke. After achieving this you
then stop using the microtabs.
There is a difference in how you stop
depending on whether you are aged
between 12 -18 years or 18 years and over.
Make sure you follow the instructions for
the age range applicable to you.
Adults 18 years and over
See the following diagram which shows the
basic step by step process.
The time given in step 2 is the longest
amount of time it should take, and you
should try to achieve your move to the next
step in the shortest time possible.
Make sure you read the instructions for
each step in the information which follows.

Preparation
Step 1

12 weeks
(3 months)
Step 2

Gradually
reduce usage
Step 3

Step 1: Set a date to quit and stop
smoking cigarettes.
Step 2: Use 1 or 2 microtabs every hour
to relieve your cravings. See
“Dosage” section to decide which
number of microtabs is suitable for
you to use.
➤ Use the microtabs for up to
12 weeks (3 months) to relieve your
cravings to smoke.
Step 3: Start reducing the number of
tablets you use each day.
Once you reach only one or two
tablets each day you should try to

i

stop completely.
➤ If you need to use the microtabs
for longer than a total of 9 months,
ask your doctor, nurse or
pharmacist for advice.
➤ You might feel a sudden craving to
smoke long after you have given
up smoking and stopped using the
NICORETTE® Microtabs.
Remember you can use nicotine
replacement therapy again if this
should happen.
Children aged 12 years and over
See the following diagram which shows the
basic step by step process. The time given
in steps 2 and 3 are the longest time
possible it should take, and you should try
to achieve your move to the next step in the
shortest amount of time. The total amount
of time taken to stop smoking should not
exceed 12 weeks.
Make sure you read the instructions for
each step in the information which follows.

Preparation
Step 1

8 weeks
(2 months)
Step 2

4 weeks
Step 3

Step 1: Set a date to quit and stop
smoking cigarettes.
Step 2: Use 1 or 2 microtabs every hour
to relieve your cravings. See
“Dosage” section to decide which
number of microtabs is suitable for
you to use.
➤ Use the microtabs for up to
8 weeks (2 months) to relieve
turn over ➤

651537

your cravings to smoke.
Step 3: Start reducing the number of
tablets you use each day over
the next 4 week period. Once you
reach only one or two tablets each
day you should try to stop
completely. You should make sure
that you do this within the 4 weeks.
➤ If you need to use the microtabs for longer
than the 12 weeks (3 months), ask your
doctor, nurse or pharmacist for advice.
i Stopping Gradually
The idea is to start gradually replacing
some of your cigarettes with the microtabs.
After achieving this you then give up
cigarettes completely while using the
microtabs. Finally you give up using the
microtabs.
There is a difference in how you stop
depending on whether you are aged
between 12 -18 years or 18 years and
over. Make sure you follow the
instructions for the age range applicable
to you.
Adults 18 years and over
See the following diagram which shows the
basic step by step process. The time given
for steps 2 and 3 are the longest it should
take, and you should try to achieve your
move to the next step in the shortest time
possible.
Make sure you read the instructions for
each step in the information which follows.

4 weeks
Preparation 24 weeks 12 weeks
(6 months) (3 months) reduce usage
Step 3
Step 4
Step 1
Step 2

Step 1: Work out how many cigarettes
you smoke per day. Set a date
to start reducing the number of
cigarettes you smoke.
Step 2: Start reducing. Over the next few
months, reduce the number of
cigarettes you smoke by using 1 or
2 NICORETTE® Microtabs every
hour to relieve your cravings. See
“Dosage” section to decide which
number of microtabs is suitable for
you to use.
➤ If after 6 weeks you have not
reduced the number of cigarettes you smoke, ask your doctor,
nurse or pharmacist for advice.
➤ You should aim to stop smoking
completely by six months from
the beginning of treatment.
Step 3: Stop smoking. Cut out all
cigarettes and continue using the
microtabs for up to 3 months to
relieve your cravings to smoke.
Step 4: Start reducing the use of the
microtabs. You should try to use
fewer microtabs each day. When
you are using only one or two
microtabs per day, you should stop
completely.
➤ If you need to use the product
for longer than 9 months, ask
your doctor, nurse or pharmacist

i

!

!

for advice.
➤ You might feel a sudden craving
to smoke long after you have
given up smoking and stopped
using NICORETTE® Microtabs.
Remember you can use nicotine
replacement therapy again if
this should happen.
Children aged 12 years and over
Children should follow the guide to
stopping immediately. The recommended
duration of nicotine replacement therapy in
children is 12 weeks maximum. The only
time children should stop gradually is if they
are having a problem stopping immediately.
Talk to your doctor, nurse or pharmacist
before attempting to stop gradually.
If you have used too many Microtabs
If you have used more than the recommended
number of NICORETTE® Microtabs you
may experience nausea, 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 has used or swallowed
Microtabs
n Contact a doctor or your nearest
hospital Accident and Emergency
department immediately if a child under
12 years uses, chews, sucks or swallows
a NICORETTE® Microtab. Take this

leaflet and the pack with you.
Nicotine ingestion by a child may result
in severe poisoning.

4 Possible side-effects

!

!

Like all medicines, NICORETTE® Microtab
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 use too few NICORETTE®
Microtabs 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® microtab
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® Microtabs and
contact a doctor immediately.
Very common side-effects:
(may affect more than 1 in 10 people):
n headache
n cough
n throat irritation
n hiccups
n feeling sick (nausea)
Common side-effects:
(may affect up to 1 in 10 people):
n allergic reactions (hypersensitivity)
n burning sensation in the mouth
n dizziness
n taste disturbance or loss of taste
n tingling or numbness of the hands and
feet
n stomach pain or discomfort
n diarrhoea
n dry mouth
n indigestion
n excessive gas or wind
n increased salivation
n sore and inflamed mouth

n sickness (vomiting)
n tiredness (fatigue)
n nasal irritation
n sore mouth or throat
Uncommon side-effects:
(may affect up to 1 in 100 people):
n abnormal dream
n sudden reddening of the face and/or
neck
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 blocked nose, sneezing
n throat tightness
n burping (belching)
n swollen red sore tongue
n mouth ulcers or blisters
n numbness or tingling of the mouth
n excessive sweating
n itching
n rash
n hives (urticaria)
n unusual weakness
n chest discomfort and pain
n jaw-muscle ache
n general feeling of discomfort or being
unwell or out of sorts (malaise)
Rare side-effects:
(may affect up to 1 in 1,000 people):
n difficulty in swallowing
n decreased feeling or sensitivity, especially
in the mouth
n feeling of wanting to be sick (vomit)

Other side-effects
n blurred vision, watery eyes
n dry throat, lip pain
n stomach discomfort
n redness of the skin
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.

5 Storing and disposal

n Keep NICORETTE® Microtab 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 NICORETTE® Microtab
above 25°C.
n Do not use NICORETTE® Microtab after
the ‘Use before’ date shown on the
carton or blister.
n Dispose of any unused NICORETTE®
Microtab 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: ß-cyclodextrin,
crospovidone, colloidal silica and
magnesium stearate.
What the medicine looks like
NICORETTE® Microtab is blister packed in
sheets of 10 microtabs, and is available in
cartons containing 10, 20, 30, 90, 100,
150 or 210 microtabs.
Not all pack sizes may be marketed.
Who makes nicorette® microtab?
The Product Licence holder is McNeil
Products Ltd, Maidenhead, Berkshire, SL6
3UG, UK.
The manufacturer is McNeil AB,
Helsingborg, Sweden.
This leaflet was revised in July 2017. ©

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