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NICORETTE INVISI 15 MG PATCH
Active substance(s): NICOTINE
Component code: 000000
version number: MPS-a
Text font: 9pt
REPLACED COMP CODE
DIELINE / TECH DRAWING REFERENCE
PDD McNeil, HBG, SWE
November 21, 2017 11:06:46
if you feel unable to stop smoking completely, or wish to
increase the time to your next cigarette with the intention
of cutting down the number of cigarettes you smoke,
■ at those times when you can’t or do not want to smoke.
where you don’t want to smoke and avoid harm to
others e.g children or family
for prolonged periods (greater than 16 hours) where
smoking cigarettes is not allowed e.g aeroplanes,
work, social occasions
It may also help increase your motivation to quit.
When making a quit attempt a behavioural support
programme will increase your chances of success.
nicorette® invisi 25 mg patch: Each patch releases
25 milligrams of nicotine, the active ingredient, over 16 hours.
nicorette® invisi 15 mg patch: Each patch releases
15 milligrams of nicotine, the active ingredient, over 16 hours.
nicorette® invisi 10 mg patch: Each patch releases
10 milligrams of nicotine, the active ingredient, over 16 hours.
What should you know about
invisi 25 mg
invisi 15 mg
invisi 10 mg
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® invisi patch 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® invisi patch to achieve this by using it to
completely replace all your cigarettes.
However, NICORETTE® invisi patch can also be used in
What does nicorette® invisi patch do?
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 apply a NICORETTE® invisi patch to the skin
nicotine is released and passes into your body through the
skin. 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.
Benefits you can get from using NRT instead of smoking
For the best effect, ensure that you use NICORETTE® invisi
patch correctly – see ”How and when to use this medicine”
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.
■ 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.
NRT 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® invisi patch:
if you have an allergy to nicotine or any of the other
■ If you are a child 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, 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 stomach ulcers or oesophagitis
(inflammation of the food pipe).
if you are to undergo an MRI procedure.
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
if you have diabetes – monitor your blood sugar levels
more often when starting to use NICORETTE® invisi
patch as you may find your insulin or medication
if you have a skin disorder such as psoriasis, eczema
or hives (urticaria) covering a large area of your skin.
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
If any of these apply, talk to your doctor, nurse
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 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:
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® invisi patch 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.
3 How and when to use this medicine
How to use nicorette® invisi patch
i Follow the instructions below.
Choosing where to apply the patch
1 Before applying your NICORETTE® invisi patch, choose
a completely clean, dry area of hairless skin on the front
or side of the chest, upper arm or hip.
2 Avoid placing the patch onto any area of skin that is red,
cut or irritated.
3 Do not apply oil or talcum powder to the skin before
putting on the patch as this may prevent it from sticking
4 It is important that you do not use the same area on two
consecutive days to help avoid irritating that site.
i How to apply the patch
1 Wash your hands before applying the
2 Each NICORETTE® invisi patch
comes in a child resistant sachet
which can be opened by cutting along
the edge with a pair of scissors.
3 Remove the patch from its sachet and
then peel one part of the silvery aluminium
backing away. Avoid touching the
sticky surface of the patch with your
4 Carefully apply the sticky part of the
patch to the chosen area of skin and
then peel off the remaining half of the
silvery aluminium backing foil.
5 Press the patch firmly onto the skin with
your palm or finger tips.
6 Run your fingers around the edge to
ensure it sticks firmly.
i Removing and disposing of the patch
1 The patch should be removed before you go to bed as
NICORETTE® invisi patch is not designed to be worn
when you go to sleep at night or for more than 16 hours
2 After removal, the patch should be folded in half, sticky
side inwards and placed inside the opened sachet or a
piece of aluminium foil.
3 The patch should then be disposed of carefully in the
household rubbish, out of reach of children and animals.
i When to use nicorette® invisi patch
If you are able to stop smoking immediately you should use
NICORETTE® invisi patch, when needed, in place of
cigarettes by following the dosing instructions detailed
under section “Stopping Immediately”.
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 NICORETTE® invisi patch. There are toxins in
cigarettes that can cause harm to your body. NICORETTE®
invisi patch 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.
If you are planning to stop smoking or reduce the number of
cigarettes you smoke, NICORETTE® invisi patch can be
used while you are still smoking. However, during this time,
you should aim to replace as many cigarettes as possible
with NICORETTE® invisi patch. As soon as you feel ready
you should stop smoking completely. Follow the dosing
instructions detailed under section “Stopping Gradually”.
You can also use NICORETTE® invisi patch on those
occasions when you can’t or don’t want to smoke e.g. long
haul flights, social situations, or when at work. However, in
smoke free areas such as pub, work breaks, public transport, car journeys etc., an alternative flexible NICORETTE®
product (e.g Gum, Inhalator) would be more suitable. Follow
the dosing instructions detailed under section “Temporary
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 NICORETTE® invisi
patch but are finding this difficult you should contact your
doctor, nurse or pharmacist for advice.
Below is the dosage information for NICORETTE® invisi
patch. This shows the number of patches you should be
using, when you should use them and where applicable the
maximum amount of time you should be using Nicotine
Replacement Therapy (NRT) for.
Please read this information carefully and then go to the
“How to stop smoking your choice” section which shows
you how to give up.
■ Depending on where you are in your treatment
programme, the strength of the patch that you are using
may differ. See the “How to stop smoking your choice”
for more information.
■ However all patches are used and applied in the same way.
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.
If you find it hard to stop smoking using NICORETTE®
invisi patch, you are worried that you will start smoking
again without it, or you find it difficult to reduce the number
of patches you are using, talk to your doctor, nurse or
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 ■ Apply one new patch (of appropriate
aged 12 years strength) to the skin when you wake
and over up (usually in the morning).
■ Remove 16 hours later which
is usually at bed time.
■ Do not use more than one patch at a time.
■ If you lose a patch whilst swimming, bathing or
showering you can replace it with another patch.
■ Dispose of the patches carefully after you have removed,
ensuring they are out of the reach of children and pets.
i Stopping Immediately
The idea is to stop smoking immediately and use the patch
to relieve the cravings to smoke. After achieving this you then
slowly reduce the amount of nicotine that you are getting by
switching to lower strength patches. You then stop using the
patches. You should aim to do this within 12 weeks (3 months).
i Adults and Children aged 12 years and over
The following diagram shows the basic step by step
process. Make sure that you read the instructions for each
step in the information which follows.
Patch reduction guide
are a lighter smoker
12 week programme
For best results, most smokers are recommended to start on
25 mg patch (Step 1) and Lighter smokers (i.e. those who
smoke less than 10 cigarettes per day) are recommended to
start at Step 2 (15 mg) for 8 weeks and decrease the dose
to 10 mg for the final 4 weeks.
Step 1: Begin treatment with the highest strength
NICORETTE® invisi 25 mg patch the day after you
stop smoking completely. Use a new NICORETTE®
invisi 25 mg patch each day for eight weeks.
Step 2: If you are successful and avoid smoking during this
eight week period, you should then begin to reduce
the amount of nicotine you are getting by switching
to a lower strength patch.
■ Now use the NICORETTE® invisi 15 mg patch each
day for two weeks.
Step 3: If you are successful and avoid smoking over this
two week period, then switch from the
NICORETTE® invisi 15 mg patch to the
NICORETTE® invisi 10 mg patch each day for a
further two weeks.
➤ You might feel a sudden craving to smoke long after
you have given up smoking and stopped using
NICORETTE® invisi patch. Remember you can use
nicotine replacement therapy again if this should
i If you experience excessive side-effects or
When using the highest strength 25 mg patch, if you
experience excessive side-effects which do not
disappear after a few days of use, you should move to
the medium strength 15 mg patch and use it for the
remainder of the 8 weeks. You should then reduce to the
low strength 10 mg patch and use it for the remaining
4 weeks of the treatment programme.
If you are a lighter smoker (less than 10 cigarettes per
day), you should start on the medium strength 15 mg patch
and use it for 8 weeks and then step down to the lower
strength 10 mg patch for the last 4 weeks of treatment.
NICORETTE® invisi patch can be used whilst you are still
smoking. The idea is to start by gradually replacing some of
your cigarettes you smoke whilst using NICORETTE® invisi
patch. After achieving this you should aim to give up
cigarettes completely whilst using the patch. Finally, you
should stop using the patch completely.
For best results, you should ideally start on 25 mg patch
(Step 1). Slowly reduce the amount of nicotine that you are
getting by switching to 15 mg (Step 2) as soon as the
number of cigarettes you smoke is less than 10 cigarettes
per day, until you have given up patches completely.
Lighter smokers (i.e. those who smoke less than 10
cigarettes per day) are recommended to start at Step 2
(15 mg). When trying to stop smoking, you are recommended to continue on 15 mg (Step 2) for 8 weeks and then
step down to the lower strength 10 mg (Step 3) for the last
4 weeks of treatment.
A patch should be applied in those situations when you are
unable to smoke e.g long haul flights, social situations or
when at work.
For best results, you should use 25 mg patch (Step 1).
However, lighter smokers (i.e. those who smoke less than
10 cigarettes per day) are recommended to use Step 2
If you have used Nicorette® invisi patch too
If you have used more than the recommended dosage of
NICORETTE® invisi patch, left the patch on for too long or
have smoked whilst using NICORETTE® invisi patch, 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
If a child uses nicorette® invisi patch
Contact a doctor or your nearest hospital Accident
and Emergency department immediately if a child
under 12 years uses, chews, sucks or swallows this
medicine. Take this leaflet and the pack with you.
Nicotine inhalation or ingestion by a child may result in
4 Possible side-effects
Like all medicines, NICORETTE® invisi patch 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
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® invisi patch before you are ready to
reduce your nicotine intake.
These effects include:
irritability or aggression
increased appetite or weight gain
urges to smoke (craving)
night time awakening or sleep disturbance
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:
feeling sick (nausea)
Side-effects of nicorette® invisi patch
When you use the NICORETTE® invisi patch for the first
time it may cause a mild skin reaction. This is usually
redness or itching of the skin where the patch has been.
This will usually disappear after a few days. Rarely the
reaction may persist or if there is a more severe skin
reaction, you should stop using the patches and consult a
doctor, nurse or pharmacist.
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 mouth, lips,
throat and tongue, itching of the skin, swelling of the skin,
ulceration and inflammation of the lining of the mouth) stop
taking NICORETTE® invisi patch and contact a doctor
Very common side-effects:
(may affect more than 1 in 10 people)
■ itching – this usually disappears within a few days
(may affect up to 1 in 10 people)
■ feeling sick (nausea)
■ sickness (vomiting)
■ hives (urticaria) or rash
not listed in this leaflet. You can also report side-effects
directly via the Yellow Card Scheme at
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:
5 Storing and disposal
(may affect up to 1 in 100 people)
■ tingling or numbness of the hands and feet
■ allergic reaction
■ flushing, high blood pressure
■ excessive sweating
■ aching muscles, muscle tenderness or weakness not
caused by exercise
■ chest discomfort and pain
■ feeling unwell or tired
(may affect up to 1 in 1,000 people)
■ difficulty in swallowing
■ pain in your hands or feet
■ stomach discomfort
■ redness of the skin – this usually disappears within a few
When you stop smoking you may develop mouth ulcers.
The reason why this happens is unknown.
Reporting of side-effects
If you experience any side-effects talk to your doctor,
pharmacist or nurse. This includes any possible side-effects
Keep NICORETTE® invisi patch out of the sight and
reach of children and animals. Nicotine in high doses
can be very dangerous and sometimes fatal if taken by
Do not store NICORETTE® invisi patch above 25°C.
Do not use NICORETTE® invisi patch after the ’Use
before’ date shown on the carton or sachet.
Dispose of NICORETTE® invisi patch as directed by
folding it in half and placing inside the empty sachet (or
wrapping in a piece of aluminium foil) before throwing
away. Always dispose of used NICORETTE® invisi
patches sensibly, away from the reach of children and
What the medicine looks like
NICORETTE® invisi patch is packed into individual sachets
and supplied in packs of 2 (25 mg only), 7 or 14 patches.
Not all pack sizes may be marketed.
Who makes nicorette® invisi patch?
The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The Manufacturer is
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2,
D-56626 Andernach, Germany.
This leaflet was prepared in November 2017. ®
6 Further information
What’s in this medicine?
The active ingredient is: Nicotine.
Other ingredients are: medium chain triglycerides, basic
butylated methacrylate copolymer, polyethylenterephthalate
film (PET), acrylic adhesive solution, potassium hydroxide,
croscarmellose sodium, aluminium acetylacetonate,
siliconised PET release liner with aluminised single side,