Active substance: NICOTINE

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Medicated chewing-gums

Pharma code 8031

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Nicotinell chewing-­
gum carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, nurse or pharmacist if you need
more information or advice.
• If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1. What Nicotinell chewing-gum is and what it is
used for
2. Before you take Nicotinell chewing-gum
3. How to take Nicotinell chewing-gum
4. Possible side effects
5. How to store Nicotinell chewing-gum
6. Further information

1. What Nicotinell chewing-gum is and what
it is used for
Nicotinell medicated chewing-gum is a nicotine
replacement therapy (NRT) which is used to help
you to stop smoking. It is available in two strengths
(2 mg and 4 mg). This leaflet is for Nicotinell
Support Icemint 2mg and 4mg medicated

Follow the chewing technique instructions in
section 3 to get the best effect.
The gum contains a number of ingredients which
help remove dental staining, chewing Nicotinell
Gums will help improve the whiteness of your teeth.
Nicotinell 2mg and 4mg gums can be used to help
• Stop smoking completely
• Cut down the amount you smoke – perhaps
before you go on to stop completely
In addition, they may be used when you:
• Do not wish to smoke. For example in confined
spaces (in the car; in the house) or where others
(such as children) could be harmed by tobacco
• Are unable to smoke
• Develop cravings once you have stopped
Reducing the number of cigarettes smoked can
increase the chances that you will move on to quit
Nicotinell 2mg gum is for smokers smoking less
than 20 cigarettes per day. It can also be used by
smokers smoking between 20 and 30 cigarettes per
Smokers of more than 20 cigarettes per day, who
are reducing their smoking prior to a quit attempt,
should use Nicotinell 2mg gums once they have
successfully reduced the number of cigarettes
smoked per day.
If you smoke more than 30 cigarettes per day, you
should use Nicotinell 4mg medicated chewing-gum.
Nicotinell 2mg and 4mg gums can also be used to
relieve breakthrough cravings of smokers attempting
to quit by following a patch programme.
If you need advice before starting to use Nicotinell
gum, talk to your doctor, nurse, pharmacist or
trained counsellor.

Take special care with Nicotinell chewing-gum
Please speak with your doctor, nurse or pharmacist
before taking the chewing-gum if you:
• Have heart disease (e.g. heart attack, disorders of
the heart rate and/or rhythm)
• have uncontrolled blood pressure
• Have or had a stroke
• Have serious liver or kidney disease
• Have or had stomach ulcer
• Have persistent indigestion
• Have a severe sore throat or inflammation of the
• Are diabetic (see next section)
• have an overactive thyroid gland
• have a tumour of the adrenal glands
• Are fructose intolerant
• Are on a low-sodium diet
• Are taking any other medicines (see next section)
• Are pregnant or breast-feeding (see pregnancy/
breast-feeding sections).
People having problems with the jawbone and some
denture wearers may experience difficulty in
chewing the gum. If you do, it is recommended that
you use a different form of nicotine replacement
therapy, such as a patch or lozenge. Ask your doctor
or pharmacist for advice.
Using nicotine replacement therapy is better than
continuing to smoke.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicine,
including medicines obtained without a prescription.
The effect of some medicines can be altered when
you stop smoking.
• If you are already taking regular medication you
should tell your doctor, nurse or pharmacist.
• Diabetics should monitor their blood sugar levels
more than usual when taking chewing gum
because your insulin/medication requirements
may alter.
Taking Nicotinell chewing-gum with food and
Coffee, juices, acidic and fizzy drinks may reduce
the absorption of nicotine and should not be taken
for 15 minutes before chewing the gum.
Smoking during pregnancy is associated with risks
such as poor growth of the baby before birth,
premature birth or still birth. Stopping smoking is
the single most effective way to improve both your
health and that of your baby. The earlier smoking
stops, the better.
Ideally, stopping smoking during pregnancy should
be done without nicotine replacement therapy.
However, if you have tried and this is not possible,
nicotine replacement therapy may be used because
the risk of the developing baby is less than that
expected from continued smoking. The decision to
use nicotine replacement therapy should be made
as early on in the pregnancy as possible with the
aim of discontinuing use after 2–3 months.
Ask your doctor for advice before taking any medicine.
It is better to use nicotine replacement therapy
products that can be taken intermittently (not
patches). Try to breast-feed at a time just before you
take the product to ensure that the baby gets the
smallest amount of nicotine possible. If you need to
use nicotine replacement therapy to help you give
up smoking, the amount of nicotine that the baby

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To help quit smoking you should also try to use a
behavioural support programme to increase your
chances of success. Talk to your doctor, nurse,
pharmacist or a trained counsellor about this.

Do NOT take Nicotinell chewing-gum if you are
• Allergic (hypersensitive) to nicotine or any of the
other ingredients of the chewing-gum
• A non-smoker or occasional smoker
• Under 12 years of age, except on the advice of a

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The chewing-gum contains nicotine, which is one of
the substances in tobacco. When chewed, nicotine
is released slowly and absorbed through the lining
of the mouth. Nicotinell chewing-gum does not
contain the other harmful substances found in the
tobacco smoke such as tar and carbon monoxide.

2. Before you take Nicotinell chewing-gum


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may receive is considerably smaller and less
harmful than the second-hand smoke they would
otherwise be breathing in.
Driving and using machines
The chewing gum is unlikely to affect your ability to
drive or operate machinery.
Important information about some of the
ingredients of Nicotinell Medicated chewing
These chewing-gums contain some ingredients of
which you may need to be aware of:
• Sorbitol: if you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicine. Each
piece of gum contains 0.1g, a source of 0.02g
• Sodium: each piece of 2mg gum contains
11.44 mg per piece. Each piece of 4mg gum
contains 11.45 per piece. To be taken into
consideration by those on a controlled sodium
• Butylhydroxytoluene (E321): an ingredient of
the gum base of Nicotinell Medicated chewing
gum which may cause local irritation to the lining
of the mouth.
For other ingredients see section 6.

3. How to take Nicotinell chewing-gum
Chew one piece of gum when you feel the urge to
smoke. It is important to chew the gum correctly,
not like ordinary chewing-gum. Follow the
­nstructions below and do NOT swallow the gum:
Chewing technique:
1. Chew one piece of gum slowly until the taste
becomes strong.
2. Rest between your gum and cheek.
3. Chew again when taste has faded.
4. Repeat this chewing routine for about 30 minutes.

• difficulty breathing or swallowing, swelling of the
mouth, face, lips, tongue or throat.
• severe itching of the skin, with a red rash or
raised lumps.
Common side effects (occur in 1 to 10 users in 100)
• Dizziness and headache.
• Hiccups, stomach trouble such as nausea,
flatulence, vomiting, heartburn, increased saliva
production, irritation of the mouth and throat and
jaw muscle ache may also occur, especially as a
result of intense chewing. Check that you are
following the correct chewing technique if you
experience these effects.
Uncommon side effects (occur in 1 to 10 users in
• Palpitations.
• Red skin rash (erythema) and itching of raised
bumps of the skin (urticaria).
Rare side effects (occur in 1 to 10 users in 10,000)
• Disturbances in heart beat rhythm and allergic
reactions. These reactions may in very few cases
be serious and include swelling of the skin,
swelling of the face and mouth, low blood
pressure and difficulty in breathing.
The chewing-gum can stick to and very rarely
damage dentures or other dental work.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
­ nwanted side effects via the internet at Alternatively you
can call Freephone 0808 100 3352 (available from
10 am to 2 pm Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

5. How to store Nicotinell chewing-gum
Keep out of the reach and sight of children.

Most people use 8–12 pieces of 2mg gum or
8–12 pieces of 4mg gum per day.
Do NOT use more than 1 piece of gum at a time,
more than 25 pieces of 2mg gum a day or 15 pieces
of 4mg gum a day.

Do not use Nicotinell gums after the expiry date
which is stated on the blister pack and box after
“EXP”. The expiry date refers to the last day of that
Do not store above 25°C.

The gum can stick to and very rarely damage
dentures or other dental work. You may prefer to use
a patch or lozenge.
After 3 months, you should try to gradually reduce
the number of pieces of gum chewed each day. You
should stop using the gum when you are only taking
1–2 pieces of gum per day.
For the relief of breakthrough carvings:
If you are attempting to quit smoking using a patch
programme, you can use these gums to relieve any
breakthrough cravings you may experience. Chew
one piece of gum if you feel the need to smoke.
Counselling may improve your chances of giving up
Children and adolescents (12–18 years) should
only use the gum for 12 weeks. If longer is required
then talk to your doctor, nurse or pharmacist.
Children under 12 years should not use the gum
unless advised by a doctor.
If you take more Nicotinell chewing-gum than
you should
If you accidentally take too many, or if a child has
eaten any, contact your doctor or nearest hospital
casualty department immediately, take the pack or
leaflet with you if possible.
Nicotine ingestion by a child may result in severe
The general symptoms of nicotine overdose include:
• Weakness, sweating, increased production of
saliva, throat burn, headache, sickness, diarrhoea
stomach pains, disturbed hearing and vision,
disturbance in heartbeat, shortness of breath and
circulatory problems
If you forget to use Nicotinell chewing-gums
Only chew the gum when you need to. Do NOT use
more than 1 piece of gum at a time or more than
25 pieces of 2mg gum a day, or 15 pieces of 4 mg
gum a day.
If you have any further question on the use of this
product, ask your doctor or pharmacist.

To dispose of used gum, wrap it paper before
putting into a waste bin. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further information
What Nicotinell chewing-gum contains:
The active substance is nicotine.
Each piece of Nicotinell 2mg medicated
­ hewing-gum contains 2mg of nicotine in a resin
complex (as 10mg nicotine polacrilin).
Each piece of Nicotinell 4mg medicated
­ hewing-gum contains 4mg of nicotine in a resin
complex (as 20mg nicotine polacrilin).
The other ingredients of Nicotinell medicated
chewing-gum are:
• Gum base (containing butylhydroxytoluene
(E321)), calcium carbonate (E170), sorbitol (E420),
sodium carbonate anhydrous, sodium hydrogen
carbonate (E500), polacrilin, glycerol (E422),
purified water, levomenthol, sucralose (E955),
acesulfame potassium (E950), xylitol (E967),
mannitol (E421), gelatin, titanium dioxide (E171),
carnauba wax (E903) and talc (E553b). See also
section 2 for further ingredient information.
• Natural mint flavouring and mint millicaps
Nicotinell gum is sugar-free.
What Nicotinell chewing-gum looks like and
contents of the pack
Each piece of chewing-gum is off-white in colour
and rectangular in shape.
Marketing authorisation holder and
Novartis Consumer Health, Camberley, GU15 3YL,
You can also find additional information and support
@ or by calling the NHS
helpline on 0800 0224322.
This leaflet was last approved in May 2014.

4. Possible side effects
GB 930611 – 31031600

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STOP using the gum and seek medical help
immediately if you have any of the following which
may be signs of an allergic reaction:

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Remember not to drink certain drinks 15 minutes
before chewing the gum (see section 2).

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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.