NICORETTE COMBI PATCH + GUM

Active substance: NICOTINE RESINATE

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2 Before using this medicine
TM

combi patch + gum
nicotine
transdermal patch and chewing gum
What you should know about
nicorette® combiTM patch + gum
nicorette® invisi 15mg patch
(15mg nicotine transdermal patch)
nicorette® icy white 2mg gum
(2mg nicotine chewing gum) Low strength
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 the medicine is for
Nicorette combi patch + gum 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. Details of Nicorette ActiveStop
are at the end of this leaflet.
nicorette® invisi 15mg patch: Each patch releases
15 milligrams of nicotine, the active ingredient,
over 16 hours.
nicorette® icy white 2mg gum: Each gum contains
2 milligrams of nicotine, the active ingredient.
What does nicorette combi patch + gum 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 apply a nicorette invisi patch to the skin,
nicotine is released and passes into your body
through the skin. When you chew nicorette icy
white gum, nicotine is released and passes into
your body through the lining of your mouth. The
nicotine obtained from the combination of the
patch and gum is sufficient to relieve 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 apply the nicorette
invisi patch correctly and chew the nicorette icy white
gum according to the Nicorette Chewing Technique –
see “How to Use Nicorette Combi Patch + Gum.”
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.

X Do not use Nicorette Combi
Patch + Gum:
I

if you have an allergy to nicotine or any of the
other ingredients.

! 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.
I 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.
I if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation of
the oesophagus (passage between the mouth
and stomach).
I if you have liver or kidney disease.
I 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.
I if you have diabetes – monitor your blood sugar
levels more often when starting to use nicorette
combi patch + gum as you may find your insulin
or medication requirements alter.
I if you have a skin disorder such as psoriasis,
eczema or hives (urticaria) covering a large area
of your skin.
I 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.
I

! If you are pregnant or breast-feeding
If you are pregnant or breast-feeding: you should
not use nicorette combi patch + gum. Although
ideally you should try to give up smoking without
NRT, some NRT products may be suitable. You should
talk to your doctor, nurse or pharmacist for advice.

! Some of the ingredients can cause
problems
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The chewing gum base contains butylated
hydroxytoluene (E321), an antioxidant, which may
irritate your mouth.

3 How and when to use this
medicine
i How to use Nicorette Combi
Patch + Gum
Follow the instructions below.

i Choosing where to apply the patch
1 Before applying your 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 invisi 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 invisi patch as this may
prevent it from sticking properly.
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 invisi patch.
2 Each 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 invisi 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 fingers.
4 Carefully apply the sticky
part of the invisi patch to
the chosen area of skin and
then peel off the remaining
half of the silvery
aluminium backing foil.
5 Press the invisi 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 invisi patch is not designed to be worn
when you go to sleep at night or for more than
16 hours each day.
2 After removal, the invisi 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 How to chew Nicorette Gum - The
Nicorette Chewing Technique
The method of chewing nicorette icy white gum is
not the same as for ordinary chewing gum. Nicorette
icy white gum is chewed to release nicotine then
rested so that nicotine can be taken in through the
lining of the mouth. If nicorette icy white gum is
chewed continuously, the nicotine is released too
quickly and is swallowed. This may irritate your
throat, upset your stomach or give you hiccups.
If you have false teeth you may have difficulty

chewing the gum as nicorette icy white gum could
stick to them and on rare occasions, damage dentures.
If you experience a problem, other single formats of
nicotine replacement therapy such as patch, inhalator
or microtab may be more suitable for you.

i The Nicorette Chewing Technique
1 Chew slowly until taste becomes strong.
2 Rest between gum and cheek.
3 Chew again when the taste has faded.
I Keep chewing like this for about half an hour.
After this time the gum will have lost its strength
and you should dispose of it carefully.

i When to use Nicorette Combi
Patch + Gum

Nicotine replacement therapy often provides sufficient
nicotine when used as single therapy. Smokers who
smoke 10 or more cigarettes per day, people who
experience breakthrough cravings, or those who
have failed to stop smoking using single NRT may
benefit from using nicorette combi patch + gum.
Below is the dosage information for nicorette combi
patch + gum. This shows the number of invisi patches
and icy white gums you should be using, when you
should use them and the maximum amount of time
you should be using nicotine replacement therapy for.
I You must stop smoking completely before using
nicorette combi patch + gum. (Step 1)
I You should use the icy white gum and invisi patch
at the same time for Step 2 of the treatment
period. See "Stopping Immediately" overleaf.

i Children under 12 years
Do not give this product to children under 12 years.

i Adults and Children 12 years and over
This table is only applicable for Step 2 of the treatment
period. See"Stopping Immediately" overleaf.
Age

Dosage of invisi patch

Dosage of icy white gum

Adults and
children aged
12 years and
over

- Apply one new invisi patch
to the skin when you wake
(usually in the morning).
- Remove 16 hours later
which is usually at bedtime.

- One as required to
relieve cravings.

I Use only one invisi patch and chew only one piece of icy white
gum at a time.
I If you lose an invisi patch whilst swimming, bathing or
showering, you can replace it with another invisi patch.
I Dispose of invisi patches carefully after you have removed
them, ensuring they are out of the reach of children and pets.
I You should use at least 4 pieces of icy white gum per day.
Most people use about 5-6 pieces a day.
I Do not use more than 15 gums per day.
I Any icy white gums which remain following Step 2 of the treatment period can be retained for use during the weaning period.
I During your weaning period regular packs of nicorette icy
white 2mg gum should be used.
I Children aged 12 to 18 years should not use for longer than
12 weeks without asking for help and advice from a doctor,
nurse or pharmacist.
I Adults aged 18 years and over should not use for longer
than 9 months without asking for help and advice from a
doctor, nurse or pharmacist.

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.

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650876
If you find it hard to stop smoking using nicorette
combi patch + gum, you are worried that you will
start smoking again without it, or you find it
difficult to reduce the amount of nicorette combi
patch + gum you are using, talk to your doctor,
nurse or pharmacist. Remember nicorette combi
patch + gum is not intended as a substitute for
smoking, it is to be used as an aid to giving up.

Step 1: Set a date to quit and stop smoking cigarettes.
Step 2: Use the invisi patch and icy white gum
together for 8 weeks (2 months). The icy
white gum should be used to relieve your
breakthrough cravings to smoke. See the
dosing table in “When to use nicorette combi
patch + gum” to see how often you can use
the invisi patch and icy white gum.
Step 3: Stop using the invisi patch and start to reduce
the number of icy white gums you use over a
period of four weeks. You should try and use
fewer pieces of gum each day. When you are
using only one or two pieces of icy white gum
per day, you should stop completely.
® Do not use for longer than 12 weeks in total
without asking for help and advice from your
doctor, nurse or pharmacist.

i Stopping Immediately
The idea is to stop smoking immediately and use invisi
patch and icy white gum together to relieve cravings
to smoke. After 12 weeks of using both the invisi patch
and icy white gum, the invisi patch is discontinued.
Only icy white gum is used for the remainder of the
treatment period. The dosage is gradually reduced
until you can stop using the icy white gum altogether.

i Adults aged 18 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
follows.
Preparation
Step 1

12 weeks
(3 months)

6-12 weeks

Step 2

Step 3

i Children aged 12 years and over
See the following diagram which shows the basic
step by step process. The times given below are the
longest amount of time they should take and you
should try to achieve your move to the next step in
the shortest time possible.
Make sure that you read the instructions for each
step in the information which follows.
4 weeks
8 weeks
(2 months)
Preparation
Step 2

Nicorette Combi Patch + Gum?
If you have used more than the recommended
amount of invisi patch or icy white gum, left the
patch on for too long, or have smoked whilst using
nicorette combi patch + gum, 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.

Up to 9 months
from the start of
treatment
Step 4

Step 1: Set a date to quit and stop smoking cigarettes.
Step 2: Use the invisi patch and icy white gum
together for 12 weeks (3 months). The icy
white gum should be used to relieve your
breakthrough cravings to smoke. See the
dosing table in “When to use nicorette
combi patch + gum” to see how often you
can use the invisi patch and icy white gum.
Step 3: Stop using the invisi patch after 12 weeks.
You should continue to use as many icy white
gums as you were using during Step 2.
Step 4: Start to reduce the number of icy white
gums you use. You should try to use fewer
pieces each day. When you are using only one
or two pieces of icy white gum per day, you
should completely stop.
® If you need to use the product for longer than
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 nicorette combi patch + gum. Remember
you can use nicotine replacement therapy again
if this should happen.

Step 1

! If you have used too much

Step 3

! If a child has used or swallowed a
Nicorette Invisi Patch or Icy White Gum

®

Contact a doctor or your nearest hospital Accident
and Emergency department immediately if a child
under 12 years uses, chews or swallows this
medicine. 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 combi patch + gum 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 combi patch + gum
before you are ready to reduce your nicotine intake.

! These effects include:
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irritability or aggression
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

Effects of too much nicotine

5 Storing and disposal

You may also get these effects if you are not used to
inhaling tobacco smoke.

I

! These effects include:
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feeling faint
feeling sick (nausea)
headache

Side-effects of Nicorette Icy White Gum
Nicorette icy white gum can sometimes cause a slight
irritation of the throat at the start of the treatment. It
may also cause increased salivation. The gum may
occasionally stick to dentures and in rare cases damage
them. Excessive swallowing of the nicotine released
from the gum may result in hiccupping.

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.

Overall side-effects for Nicorette Combi
Patch + Gum
Very common side-effects:
(more than 1 in every 10 people are affected)
I itching – this usually disappears within a few days
I headache
I sore mouth or throat
I jaw-muscle ache
I stomach discomfort
I feeling sick (nausea)
I hiccups

Common side-effects:
(less than 1 in every 10 people are affected)
I dizziness
I sickness (vomiting)
I redness of the skin – this usually disappears within a
few days

Uncommon side-effects:
(less than 1 in every 100 people are affected)
I hives (urticaria)
I chest palpitations

Rare side-effects:
(less than 1 in 1,000 people are affected)
I allergic reactions (swelling of the mouth, lips, throat and
tongue, itching of the skin, swelling of skin, ulceration
and inflammation of the lining of the mouth)

Very rare side-effects:
(less than 1 in 10,000 people are affected)
I abnormal beating of the heart

®
®

If you notice these or any other unwanted effects
not listed in this leaflet tell your doctor, nurse or
pharmacist.
When you stop smoking you may also develop mouth
ulcers. The reason why this happens is unknown.

Keep nicorette combi patch + gum out of reach and
sight of children and animals.
Nicotine in high doses can be very dangerous and
sometimes fatal if taken by small children.
I Do not store nicorette combi patch + gum above 25°C.
I Do not use the icy white gum or the invisi patch after
the 'Use before' date on the box, blister strip or sachet.
I Dispose of invisi patches and icy white gums sensibly
away from children and animals. Dispose of invisi
patches as directed by folding it in half and placing
inside the empty sachet (or wrapping in a piece of
aluminium foil) before throwing away. 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.
I

6 Further information
What’s in this medicine?

The active ingredient is nicotine. Each invisi patch
releases 15 milligrams of nicotine, over 16 hours. Each
icy white gum contains 2 milligrams of nicotine.
Other ingredients of the invisi patch 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, printing inks.
Other ingredients of the gum are: chewing gum base,
xylitol, acesulfame potassium, anhydrous sodium
carbonate, sodium hydrogen carbonate, peppermint
oil, levomenthol, magnesium oxide, E171, E321, starch,
carnauba wax, winterfresh, hypromellose, sucralose,
polysorbate 80, talc.
The chewing gum base contains butylated hydroxy
toluene (E321), an anti-oxidant.

What the medicine looks like
The invisi patch is packed into individual sachets. The
icy white gums are blister packed in strips of 10 gums.
Nicorette icy white 2 mg gum is a white square coated
piece of gum.
Each nicorette combi patch + gum pack pack contains
7 invisi patches and 70 icy white gums.

Who makes Nicorette Combi
Patch + Gum?
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 August 2009.

Information about Nicorette ActiveStop
Nicorette ActiveStop is a personalised support you,
with the aim of helping you give up smoking. All you
need is internet access and a mobile telephone.
Call 0800 244 838 for information.

Expand view ⇕

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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