Skip to Content

UK Edition. Click here for US version.

NICOTINE 2 MG MEDICATED CHEWING GUMS

Active substance(s): NICOTINE RESINATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Nicotine
2 mg Medicated Chewing Gums
4 mg Medicated Chewing Gums
Please read right through this leaflet before you start using this medicine. This medicine
is available under either of the above names but it will be called Nicotine Gum throughout this
leaflet. This medicine is available without prescription, but you still need to use Nicotine Gum
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask a healthcare professional (doctor, nurse, smoking
cessation advisor or pharmacist).
In this leaflet:
1. What Nicotine Gum does
2. Check before you use Nicotine Gum
3. How to use Nicotine Gum
4. Possible side effects
5. How to store Nicotine Gum
6. Further information
1. What Nicotine Gum does
Nicotine Gum is used to help people stop smoking. It works by replacing some of the
nicotine you get from cigarettes. This type of treatment is called Nicotine Replacement
Therapy (NRT).
The nicotine in cigarettes makes them addictive, but other substances in cigarette smoke, such
as tar, carbon dioxide and other toxins, are more harmful to your health. NRT products like
Nicotine Gum do not have the health dangers of tobacco.
The nicotine from NRT reduces your cravings for cigarettes and helps you resist the urge to
smoke. It also relieves some of the unpleasant symptoms (like feeling ill or irritable) that
smokers have when they try to give up.
Nicotine Gum can be used to help you:
• stop smoking straightaway (a quit attempt)
• cut down on smoking, perhaps before you go on to stop completely (reducing to quit or just
reducing).
In addition, Nicotine Gum may be used when you:
• do not wish to smoke or are unable to smoke, for example in confined spaces (in the car, in
the house), where others (such as children) could be harmed by tobacco smoke or in places
where smoking is prohibited (temporary abstinence).
• develop cravings once you have stopped smoking.
Reducing the number of cigarettes smoked can increase the chances that you will go on to quit
completely.

Nicotine Gum can be used during pregnancy and breast-feeding (see Pregnancy and Breastfeeding below).
Some people worry that, when they have stopped smoking, they may become dependent on
NRT instead. This is very rare, and if it were to happen it is still safer than continuing to
smoke. It is also an easier habit to break.
It is always better to stop smoking completely. Smoking is harmful and has no health
benefits. NRT products like Nicotine Gum can help you stop. Any risks or possible sideeffects of nicotine from NRT are much less than the proven dangers of continuing to smoke.
Your chance of stopping smoking will be improved if you also take part in a support
programme. These ‘Stop Smoking’ programmes are known as behavioural support.
For more information:
• call the NHS Free Smoking Helpline on 0800 022 4332, or visit
http://www.smokefree.nhs.uk [or the Irish National Smokers Quitline on 1850 201 203]
• or visit http://www.niquitin.co.uk for information about a free online support plan.
2. Check before you take Nicotine Gum
Do not take Nicotine Gum:
• if you have ever had an allergic reaction to nicotine or any of the other ingredients (listed in
Section 6)
• if you are a non-smoker.
• if you are under 12 years. The level of nicotine in NRT is not suitable for children under
12. Children are more susceptible to the effects of nicotine, and it could cause severe toxicity,
which can be fatal.
Take special care with Nicotine Gum
Get help and advice from a healthcare professional:
• if you are in hospital because you have had a heart attack, severe heart rhythm
disturbances or a stroke. Try to quit smoking without NRT unless your doctor has told you
to use it. Once you are discharged from hospital, you can use NRT as normal.
• if you have diabetes. When you start using NRT, you need to monitor your blood sugar
levels more often than usual, because your dose of medication for diabetes may need to be
adjusted.
• if you have serious liver or kidney problems because you may be more likely to get side
effects.
• if you have uncontrolled overactive thyroid gland or an adrenal gland tumour
(phaeochromocytoma) because nicotine may make your symptoms worse.
• if you have stomach or duodenal ulcers or inflammation of the oesophagus or gullet (the
passage between the mouth and stomach) because swallowing nicotine can make your
symptoms worse. It may also cause mouth ulcers. If your

symptoms do get worse you should talk to your doctor. You might want to use a non-oral
form of NRT instead, such as patches.
• If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this product. Nicotine Gum contains sorbitol (E420) and maltitol.
• If you have had allergic reactions that involve swelling of the lips, face and throat
(angiodema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of
reaction.
• If you are on a low sodium diet. Each piece of gum contains 11.4 mg sodium and the
maximum daily dose (15 pieces of gum) contains 171 mg sodium. The maximum daily dose
may be harmful if you are on a low sodium diet.
• Before using if you have ever experienced seizures (fits).
If you are taking other medicines
Stopping smoking may alter the effect of other medicines you may be taking. If you have any
questions or concerns about this, talk to a healthcare professional.
Other things you may need to know:
• Nicotine Gum contains butylhydroxytoluene (E 321) which may cause irritation to the
mouth or the skin around it.
• Nicotine Gum is sugar-free.
• If you wear dentures (false teeth) that are poorly fitting or not clean you may have
difficulty chewing the gum. Another NRT product may be more suitable for you, such as
patch or lozenge.
Pregnancy and breast feeding
If you are pregnant or planning to become pregnant
Smoking when you are pregnant is harmful to the baby. The risks include poor growth
before birth, damage to the baby’s lungs, premature birth and stillbirth. Stopping smoking is
the best way to improve your health and the health of your baby, and the earlier you stop
smoking the better.
It is best to give up smoking without using NRT. If that’s too difficult, using NRT is safer
for you and your baby than continuing to smoke. The nicotine in NRT is less dangerous than
the more harmful substances in cigarette smoke, such as tar and other toxins.
If you have tried to stop smoking without using NRT, and haven’t been able to, your
healthcare advisor may recommend NRT to help you stop. If you do have to use NRT during
pregnancy:
• Start as early in your pregnancy as possible.
• Aim if possible to use NRT for only 2 to 3 months. But remember- the most important thing
is not to smoke. It is safer to carry on using NRT than to start smoking again.
• If you can use them, NRT gum or lozenges are better than patches. That’s because you will
not be absorbing nicotine into your body all the time. But if you feel sick, you may need to
use NRT patches instead.

If you are breast feeding
Tobacco smoke is harmful to babies and children, causing breathing difficulties and other
problems.
If you are breast feeding, it is best if you stop smoking without using NRT. But if you do need
to use NRT, the nicotine that gets into breast milk is less dangerous to your baby than
breathing in second-hand smoke. If you do use NRT whilst breast-feeding:
• It is better to use NRT gum or lozenges to control your cravings as they happen, rather than
patches. With gum or lozenges, you will not be absorbing nicotine into your body all the time.
• Try to breast-feed just before you take gum or lozenge, when the nicotine levels in your
body are at their lowest. That way, your baby gets as little nicotine as possible.
3. How to use Nicotine Gum:
Adults and young people aged 12 years and over
Instructions for use of Nicotine Gum depend on whether you are:
• stopping smoking straightaway.
• cutting down on smoking before you stop.
• cutting down with no immediate plans to stop.
• going without cigarettes for a short time.
Or if you having cravings after you have stopped smoking.
If you are under 18 years old and not ready to stop smoking straightaway, talk to a
healthcare professional for advice.
In all cases:
• Nicotine 4 mg Gum is for smokers who smoke within 30 minutes of waking.
• Nicotine 2 mg Gum is for smokers who smoke more than 30 minutes after waking.
• You should put a piece of gum in your mouth and periodically chew it, as described in the
instructions below, for about 30 minutes. Dispose of it carefully.
• Do not use more than 15 pieces of gum a day.
Nicotine Gum is not suitable for children under 12 years of age or for non-smokers.
They may develop signs of nicotine overdose, including headache, sickness, stomach pain and
diarrhoea.
Stopping smoking straightaway
Adults and young people aged 12 years and over:
It is important to make every effort to stop smoking completely. But if you do sometimes
smoke a cigarette while using NRT, don’t be discouraged- just keep going with your quit
attempt. It may help to talk to a healthcare professional if you are finding your quit attempt
difficult.

• Use 8-12 pieces of gum a day. Take a piece of gum whenever you have an urge to smoke.
• Use the gum like this for up to 3 months in total, then gradually reduce the number of pieces
you use a day.
• Once you are only using 1-2 pieces of gum a day, try to stop using it altogether.
• If you started using the 4 mg gum, you can change to the 2 mg gum during the reduction
stage.
To increase your chances of success, complete the step down programme in full and follow a
stop smoking behavioural support programme- see the end of section 1 for more details.
Cutting down on smoking before you stop
Adults aged 18 years and over:
You may find it easier to quit completely later if you use Nicotine Gum to help you cut down
on smoking first.
When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help
you manage your cravings. Cut down the number of cigarettes you smoke each day after 6
weeks, talk to a healthcare professional.
As soon as you feel ready to stop smoking completely, follow the instructions above, under
‘Stopping smoking straightaway’. If you have not felt able to make a quit attempt within 6
months of starting to use NRT, you may find it helpful to talk to a healthcare professional.
Cutting down with no immediate plans to stop
Adults aged 18 years and over:
It is always best to stop smoking completely, but using NRT to cut down is less harmful than
continuing to smoke heavily. Cutting down the number of cigarettes you smoke each day will
make it easier to quit completely in future.
When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help
you manage your cravings. Cut down the number of cigarettes you smoke per day by as many
as possible.
It is best to stop smoking completely as soon as you feel able to. Follow the instructions
above, under ‘Stopping smoking straightaway’.
Going without cigarettes for a short time
Adults aged 18 years and over:
Nicotine Gum can help you manage your cravings so that you can resist cigarettes in
situations where smoking is inappropriate, for example:
• where your second-hand smoke may damage other people, such as children.

• where smoking is not allowed, such as on a flight or in a hospital.
• when smoking should be avoided, such as before surgery.
When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help
you manage your cravings. Continue to use one piece of gum every 1-2 hours (maximum 15 a
day) during the period when you are avoiding smoking.
It is best to stop smoking completely as soon as you feel able to. Follow the instructions
above, under ‘Stopping smoking straightaway’.
Once you have stopped smoking...
After you have stopped smoking, you may still sometimes feel a craving for a cigarette. You
can use Nicotine Gum again to help you relieve these cravings- using NRT is always better
than smoking again.
If you are worried that you may start smoking again, talk to a healthcare professional. They
can advise you on how to get the best results from further courses of NRT.
If you are finding it difficult to stop using NRT completely, talk to a healthcare professional.
How to use the gum
The method of chewing nicotine gum is not the same as for ordinary chewing gum. The
gum is chewed to release nicotine then rested, so that nicotine can be taken into your system
through the lining of the mouth. If the nicotine gum is chewed continuously, the nicotine is
released too quickly and swallowed. This may irritate your throat, upset your stomach and
give you hiccups.
• Chew a piece of gum when you feel the urge to smoke.
• Chew slowly until the taste becomes strong (about 1 minute) then stop and rest the gum
against your cheek.
• When the taste fades chew a few times until the taste gets strong then rest the gum again.
• Keep chewing like this for about half an hour.
• When the gum has lost its strong taste you should dispose of it carefully.
If you use more Nicotine Gum than you should
If a child has used or eaten any of the gum, contact your doctor or hospital emergency
department immediately.
If possible, show them the Nicotine Gum packet or this leaflet. Symptoms of nicotine
overdose in children include headache, sickness, stomach pain and diarrhoea.
If you take too much gum, you may start to feel sick, dizzy and unwell. Stop using the gum
and contact your doctor or hospital emergency department immediately.
4. Possible side effects

Like all medicines, the nicotine in NRT products can have side-effects. They are similar to
those you might get from the nicotine in cigarettes, and are more likely the more nicotine you
take, but not everybody gets them. At the recommended doses Nicotine Gum has not been
found to cause any serious side-effects.
Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep
disturbance and more mouth ulcers than usual.
Other side-effects may include:
Troublesome side-effects that do not improve.
Very rare: Severe allergic reaction symptoms which include sudden wheeziness or tightness
of the chest, rash & feeling faint.
Stop taking the gum and tell a healthcare professional if you get these.
• Allergic reactions e.g. swelling, a rapid irregular heartbeat or palpitations (feeling your heart
beat).
• Sore/irritated throat, more saliva than usual, hiccups.
• Feeling sick, stomach pains, jaw ache.
• Red or itchy skin
• Seizures (fits), stop using this medicine if you experience seizures.
Tell a healthcare professional if you get any of these.
If you wear dentures it is possible that the gum may stick to them or, in rare cases, damage
them.
If you do get any side-effects, even those not mentioned in this leaflet, tell a healthcare
professional.
5. How to store Nicotine Gum
• Keep out of sight and reach of children.
• Do not use this medicine after the ‘EXP’ date shown on the blister pack and outer
packaging. The expiry date refers to the last day of the month.
• Keep all pieces of gum in the carton, in their blister pack, until you are ready to use one.
• Do not store above 25˚C.
• 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.
6. Further information
What Nicotine Gum contains
The active substance is nicotine. Each chewing gum contains 2 mg or 4 mg (in the form of a
resin complex called nicotine resinate). The other ingredients are chewing gum base,
calcium carbonate, butylhydroxytoluene (E 321), sorbitol (E 420), maltitol liquid (E965),
glycerol, acesulfame potassium, mint flavour, mannitol (E 421), sodium carbonate anhydrous,
sodium hydrogen carbonate,carnauba wax and talc. Nicotine 4 mg Gum also contains colour
quinoline yellow (E 104).

What Nicotine Gum looks like and the contents of the pack
Rectangular, pillow-shaped gum. The 2 mg gum is off-white and the 4 mg gum is yellow.
Packs contain 12, 24 or 96 pieces.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is GlaxoSmithKline Consumer Healthcare, Brentford,
TW8 9GS, U.K. and all enquiries should be sent to this address.
The manufacturer of Nicotine Gum is Fertin Pharma A/S, 7100 Vejle, Denmark.
If you have any questions or comments about Nicotine Gum, please FREEPHONE our
Information Line on 0500 100 222 or email customer.relations@gsk.com.
This leaflet was last revised in 02/2014.

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.

Hide