United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
icy white 2 mg and 4 mg gum
Nicotine chewing gum
What you should know about
icy white 2 mg gum
(2 mg nicotine chewing gum)
icy white 4 mg gum
(4 mg nicotine chewing gum)
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
gum 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.
gum can also be used when you are pregnant
or breast-feeding to help you stop smoking, as the risks to
your baby are far less than if you continue to smoke. For
more information, see ’If you are pregnant or breast-feeding’
Ideally you should always aim to stop smoking. You can use
gum to achieve this by using it to completely
replace all your cigarettes.
gum can also be used in other ways,
n if you feel unable to stop smoking completely, or wish to
replace certain cigarettes and therefore it can help you to
cut down the number of cigarettes you smoke,
n 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.
- Smoke free areas e.g Pub, work, public transport e.g
It may also help increase your motivation to quit.
When making a quit attempt a behavioural support
programme will increase your chances of success.
If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine
gum will help relieve your cravings.
If you smoke more than 20 cigarettes a day, the 4 mg
nicotine gum may be more appropriate.
What does nicorette
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 chew NICORETTE
gum, nicotine is released
and passes into your body through the lining of your mouth.
The nicotine released from the gum is sufficient to relieve the
unpleasant withdrawal symptoms. It will also help to stop the
craving to smoke, but NICORETTE
gum will not give you
the “buzz’’ you get from smoking a cigarette.
The gum contains a number of ingredients which help
remove dental staining, chewing NICORETTE
help improve the whiteness of your teeth.
Benefits you can get from using NRT instead of
For the best effect, make sure you chew nicorette
correctly. See ‘How to chew NICORETTE
gum - the
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
n 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
Nicotine replacement therapy can help relieve nicotine
withdrawal symptoms such as irritability, low mood,
anxiety, restlessness and cravings when used in place of
n 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
Do not use nicorette
n If you are a child under 12 years of age.
n if you have an allergy to nicotine or any of the other
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, inflamma-
tion 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
n if you have diabetes – monitor your blood sugar levels
more often when starting to use NICORETTE
gum 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
➤ If any of these apply, talk to your doctor, nurse or
Some of the ingredients can cause
icy white gums contain butylated hydroxy
toluene (E321), an anti-oxidant, which may irritate your
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, including NICORETTE
gum 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
gum 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
When to use nicorette
The table below contains the dosage information for
gum. This shows the number of gums you
should be using, when and how you should take them.
Please read this information carefully and then go to the
“How to stop smoking:” section, which will help you decide
which method to use to give up smoking.
n Use the “How to chew NICORETTE
gum - the
chewing technique” instructions which
follow. The method of chewing is NOT the same as that
for ordinary chewing gum. This way of chewing ensures
that the nicotine is correctly released from the gum.
n The number of NICORETTE
gums you use each day will
depend on how many cigarettes you smoked and how
strong they are.
n The 2 mg gums should be used by people who smoke
20 or fewer cigarettes each day or by heavier smokers
when they are cutting down the number and strength of
gums they are using.
n The 4 mg gums should be used by people who smoke
more than 20 cigarettes each day.
Children aged under 12 years
Do not give this product to children under 12 years.
Adults and Children 12 years and over
Dose of Gums
smoke per day
One 2 mg gum as
required to relieve cravings.
One 4 mg gum as
required to relieve cravings.
Use only one piece of gum at a time.
Do not use more than 15 gums per day.
The frequency with which you use the gums will depend
on how many cigarettes you smoked and how strong
How to chew nicorette
gum – the
The method of chewing NICORETTE
gum is not the same
as for ordinary chewing gum. NICORETTE
gum is chewed
to release nicotine then rested so that nicotine can be taken
in through the lining of the mouth.
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
gum could stick to them and on rare
occasions, damage dentures. If you experience a problem,
other types of nicotine replacement therapy such as a skin
patch, inhalator or microtab may be more suitable for you.
1 Chew slowly until taste becomes strong.
2 Rest between gum and cheek.
3 Chew again when the taste has faded.
n 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.
How to stop smoking:
If you are able to stop smoking you should use
gum, when needed, in place of cigarettes. As
soon as you can (this could be after a number of weeks or
months) you should reduce the number of gums you use
until you have stopped using them completely.
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
gum. There are toxins in
cigarettes that can cause harm to your body. NICORETTE
gum provides a safer alternative to smoking, for both you
and those around you. Reducing the number of cigarettes
may also help you to become more motivated to stop
smoking. As soon as you are ready you should aim to stop
You can also use NICORETTE
gum on those occasions
when you can’t or don’t want to smoke e.g. Social situations
such as a party, in the pub or when at work.
turn over ➤
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
gum but are
finding this difficult you should contact your doctor, nurse or
pharmacist for advice.
If you have used too many gums
If you have used more than the recommended dosage you
may experience nausea (feeling sick), 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 the gums
n 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
4 Possible side-effects
Like all medicines, NICORETTE
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
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
gum before you are ready to reduce your
These effects include:
n irritability or aggression
n feeling low
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
These effects include:
n feeling faint
n feeling sick (nausea)
n hiccuping (due to excessive swallowing of nicotine)
Side-effects of nicorette
gum can sometimes cause a slight irritation
of the throat at the start of the treatment. It may also cause
Those who suffer from indigestion may suffer from heartburn
or indigestion and may benefit from slower chewing and use
of the 2 mg gum.
The gum may occasionally stick to dentures and in rare
cases damage them.
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
gum and contact a doctor immediately.
Very common side-effects:
(may affect more than 1 in 10 people):
n throat irritation
n (feeling sick) nausea
n sore mouth or throat
(may affect up to 1 in 10 people):
n allergic reactions (hypersensitivity)
n taste disturbance or loss of taste
n tingling or numbness of the hands and feet
n stomach pain or discomfort
n dry mouth
n excessive gas or wind
n increased salivation
n sore and inflamed mouth
n sickness (vomiting)
n burning sensation in the mouth
n tiredness (fatigue)
(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 unusual weakness
n chest discomfort and pain
n hives (urticaria)
n excessive sweating
n jaw-muscle ache
n general feeling of discomfort or being unwell or out of
(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 can include:
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
gum 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
gum above 25°C.
n Do not use the gum after the ‘Use before’ date on the box
or blister strip.
n Dispose of NICORETTE
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 in NICORETTE
icy white 2 mg gum is
2 mg Nicotine.
The active ingredient in NICORETTE
icy white 4 mg gum is
4 mg Nicotine.
Other ingredients are: Chewing gum base, xylitol,
peppermint oil, anhydrous sodium carbonate, acesulfame
potassium, levomenthol, magnesium oxide, talc, winterfresh,
hypromellose, sucralose, polysorbate 80, starch, titanium
dioxide (E171) and carnauba wax. The chewing gum base
contains butylated hydroxy toluene (E321), an antioxidant.
The 2 mg gum also contains sodium hydrogen carbonate.
The 4 mg gum also contains quinoline yellow (E104) (yellow
None of the gums contain sugar (sucrose) or animal
What the medicine looks like
icy white 2 mg gum is a whitish square
coated piece of gum.
icy white 4 mg gum is a crème square coated
piece of gum.
Pack types and pack sizes:
The gums are blister-packed in sheets of 6, 10 or 15 and
supplied in packs of 10, 12, 15, 30, 105 and 210 pieces.
The gums are loose-filled packed in a cardboard box,
wrapped in a transparent plastic film, containing 25 pieces
and supplied in packs of 25, 100 (4x25) and 200 (8x25).
Not all pack types and sizes may be marketed.
Who makes nicorette
The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg, Sweden.
This leaflet was prepared in June 2017.
Nicorette Icy White 2mg Gum
Summary of Product Characteristics Updated 02-Jun-2016 | McNeil Products Ltd
1. Name of the medicinal product
Nicorette Icy White 2 mg Gum
Boots NicAssist Ice Mint 2 mg Gum.
2. Qualitative and quantitative composition
Chewing Gum containing 2 mg nicotine, as nicotine resinate.
For excipients, see 6.1.
3. Pharmaceutical form
Medicated Chewing Gum
A square, coated, white coloured piece of gum
4. Clinical particulars
4.1 Therapeutic indications
Nicorette Icy White 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms
associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to
quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for
smokers and those around them.
Nicorette Icy White 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.
4.2 Posology and method of administration
Adults and Children over 12 years of age
Nicorette Icy White 2 mg Gum should be chewed slowly according to the instructions.
The strength of gum to be used will depend on the smoking habits of the individual. In general, if the
patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per
day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine
levels from heavy smoking.
Nicorette Icy White 2 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings
in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the
Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.
Smokers aiming to reduce cigarettes should use Nicorette Icy White 2 mg Gum, as needed, between
smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as
As soon as they are ready smokers should aim to quit smoking completely.
Maximum daily dose: 15 pieces per day.
When making a quit attempt behavioural therapy, advice and support will normally improve the success
rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Icy White 2 mg
Gum are recommended to contact their pharmacist or doctor for advice.
For those using the 4mg gum, switching to the 2 mg gum may be helpful when stopping treatment or
reducing the number of gums used each day.
The chewing gums should be used whenever there is an urge to smoke according to the chew and rest
technique described on the pack. After about 30 minutes of such use, the gum will be exhausted.
Absorption of nicotine is through the buccal mucosa, any nicotine, which is swallowed being destroyed
by the liver.
Hypersensitivity to nicotine or any component of the chewing gum.
Nicorette Icy White 2mg Gum is contraindicated in children under the age of 12 years.
4.4 Special warnings and precautions for use
Any risks that may be associated with NRT are substantially outweighed by the well-established dangers
of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease this product presents a lesser hazard
than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial
infarction, unstable or worsening angina including Prinzmetal's angina, severe dysrhythmia or CVA and
who are considered to be haemodynamically unstable and/or who suffer with uncontrolled hypertension
should be encouraged to stop smoking with non-pharmacological interventions. If this fails, this product
may be considered, but as data on safety in this patient group are limited, initiation should only be under
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels
more closely than usual when NRT is initiated as catecholamines released by nicotine can affect
GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis,
gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions.
Ulcerative stomatitis has been reported.
Renal or hepatic impairment: This product should be used with caution in patients with moderate to
severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites
may be decreased with the potential for increased adverse effects.
Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce
severe toxicity in small children that may be fatal. Products containing nicotine should not be left where
they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines,
this product should be used with caution in patients with uncontrolled hyperthyroidism or
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs
metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in
slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical
importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.
Excipients: This product also contains butylated hydroxy toluene (E321); this may cause irritation to the
Denture warning: Smokers who wear dentures may experience difficulty in chewing this product . The
chewing gum may stick to, and may in rare cases damage dentures.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely
been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e.
increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain)
provoked by adenosine administration.
4.6 Fertility, pregnancy and lactation
In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and
significantly increases the risk of infertility.
In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage.
Spermatozoa from smokers have reduced fertilizing capacity.
The specific contribution of nicotine to these effects in humans is unknown.
Stopping smoking is the single most effective intervention for improving the health of both the pregnant
smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during
pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to)
quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that
expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable
this product may be used in pregnancy as a safer alternative to smoking. Because of the potential for
nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is
significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when
the fetus would not normally be exposed to nicotine.
The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the
infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast
milk and permit feeding when levels were at their lowest.
4.7 Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Effects of Smoking Cessation
Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can
include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration,
increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and
decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.
Adverse Drug Reactions
This product may cause adverse reactions similar to those associated with nicotine given by other means,
including smoking, and these are mainly dose-dependent. At recommended doses this product has not
been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients
occur during the first 3-4 weeks after start of treatment.
Excessive consumption of this product by those who have not been in the habit of inhaling tobacco smoke
could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at
first, cause hiccupping.
Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and
may also cause increased salivation.
Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if
the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more
frequently) will usually overcome this problem.
The chewing gum may stick to, and may in rare cases damage dentures.
The adverse reactions observed in patients treated with oral nicotine formulations during clinical trials
and post-marketing experience are listed below by system organ class (SOC). Frequencies are defined in
accordance with current guidance, as: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1
000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), Not known - cannot be estimated from
the available data.
System Organ Class
Reported Adverse Event
Immune System Disorders
Nervous System Disorders
Reversible atrial fibrillation
Respiratory, Thoracic and
Sore mouth or throat
Oral mucosal blistering and
Skin and Subcutaneous Tissue
Musculoskeletal and Connective
Pain in jaw
General Disorders and
Administration Site Conditions
Chest discomfort and pain
Allergic reactions including
Tightness of jaw and pain in jaw with nicotine gum formulation
At the application site
Identified only for formulations applied during the night
Higher frequency observed in clinical studies with inhaler formulation.
***Reported the same or less frequently than placebo
Although the frequency in the active group is less than that of the placebo group, the frequency in the
specific formulation in which the PT was identified as a systemic ADR was greater in the active group
than the placebo group.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card Scheme at:
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to
60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea,
sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms
may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration,
circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the patient should be
treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal
reduces the gastro-intestinal absorption of nicotine.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in nicotine dependence
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette
2mg Gum are comparatively small. The response at any one time represents a summation of stimulant and
depressant actions from direct, reflex and chemical mediator influences on several organs. The main
pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral
vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and
stimulation of peristalsis.
The gum contains a number of ingredients that are recognized as having properties for removal of dental
staining. Clinical studies have shown that the gum helps to improve tooth whiteness.
Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is
common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight
following a quit attempt.
5.2 Pharmacokinetic properties
Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes.
Demonstrable blood levels are obtained within 5 7 minutes and reach a maximum about 30 minutes
after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and
have been shown never to exceed those obtained from smoking cigarettes.
5.3 Preclinical safety data
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.
There are no other findings derived from preclinical testing of relevance to the prescriber in determining
the safety of the product, which have not been considered in other relevant sections of this Summary of
6. Pharmaceutical particulars
6.1 List of excipients
Chewing gum base, containing butylated hydroxy toluene (E321)
Sodium carbonate, anhydrous
Sodium hydrogen carbonate
Magnesium oxide, light
Titanium dioxide (E171)
6.3 Shelf life
Blister: 3 years
Box: 2 years. Shelf life after opening 3 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
PVC/PVDC/Al Blister packed strips each containing 6,10 or 15 pieces supplied in packs of 10, 12, 15, 30,
105 and 210 pieces.
Laminated cardboard box, wrapped in a transparent plastic film, containing 25 pieces, supplied in packs
of 25, 100 and 200.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Dispose of Nicorette Gum sensibly.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
McNeil Products Limited
Berkshire SL6 3UG
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
18 May 2016
Company Contact Details
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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