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NIQUITIN MINIS MINT 4MG LOZENGES

Active substance: NICOTINE RESINATE

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NiQuitin Minis
Mint 1.5 mg & 4 mg lozenges
Nicotine

Please read right through this leaflet before you start using this
medicine. This medicine is available without prescription, but you
still need to use NiQuitin Minis carefully to get the best results
from them.

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.
serious liver or kidney problems, because you
uncontrolled overactive thyroid gland or an
adrenal gland tumour

NiQuitin Minis Mint 1.5 mg & 4 mg
Lozenges are referred to as NiQuitin Minis.

stomach or duodenal ulcers or inflammation of
the oesophagus or gullet (the passage between the mouth

In this leaflet:
1. What NiQuitin Minis do
2. Check before you use NiQuitin Minis
3. How to use NiQuitin Minis
4. Possible side-effects
5. How to store NiQuitin Minis
6. Further information

might want to use a non-oral form of NRT instead, such as
patches.
allergic reactions that involve swelling of
the lips, face and throat
itchy skin rash
reaction.

1. What NiQuitin Minis do
NiQuitin Minis are used to help people stop smoking.

If you are taking other medicines

from cigarettes. This type of treatment is called Nicotine
Replacement Therapy (NRT).
healthcare professional.
NRT
products like NiQuitin Minis do not have the health dangers
of tobacco.
The nicotine from NRT reduces your cravings for cigarettes

Pregnancy and breast-feeding
If you are pregnant or planning to become pregnant
Smoking when you are pregnant is harmful to the baby. The
best way to improve your health and the health of your baby,

NiQuitin Minis can be used to help you:
(a quit attempt).

It is best to give up smoking without using NRT.
too difficult, using NRT is safer for you and your baby than

completely (reducing to quit or just reducing).

(temporary abstinence).

pregnancy:

NiQuitin Minis can be used during pregnancy and breastfeeding (see Pregnancy and breast-feeding

patches.

they may become dependent on NRT instead. This is very
rare, and if it were to happen it is still safer than continuing
It is always better to stop smoking completely.

NRT patches instead.

If you are breast-feeding
Tobacco smoke is harmful to babies and children, causing
breathing difficulties and other problems.

side-effects of nicotine from NRT are much less than the
Your chance of stopping smoking will be improved if you
also take part in a support programme.
behavioural support. For more
information:
0800 022 4332, or
visit http://www.smokefree.nhs.uk
1850 201 203]
http://www.niquitin.co.uk for information about a
free online support plan.

cravings as they happen, rather than patches. With gum or
all the time.
when the nicotine levels in your body are at their lowest.
That way, your baby gets as little nicotine as possible.

2. Check before you use NiQuitin Minis

3. How to use NiQuitin Minis

Do not use NiQuitin Minis:
allergic reaction to nicotine, or any
of the other ingredients (listed in Section 6).
non-smoker.
aged under 12. 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

Adults and young people aged 12 years and over
are:

Take special care with NiQuitin Minis
Get help and advice from a healthcare professional:
hospital because you have had a heart attack,
severe heart rhythm disturbances or a stroke. Try to stop

If you are under 18 years old

NiQuitin Minis Mint 4 mg Lozenges
more than 20 cigarettes a day.
NiQuitin Minis Mint 1.5 mg Lozenges
fewer than 20 cigarettes a day.

it. Once you are discharged from hospital, you can use NRT
as normal.

move it from one side of your mouth to the other, until it
10 minutes.

NiQuitin Minis are not suitable for children under 12 years of
age or for non-smokers. They may develop signs of nicotine
diarrhoea.

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Stopping smoking straightaway
Adults and young people aged 12 years and over:

using them altogether.
behavioural support programme
1 for more details.

Cutting down on smoking before you stop
Adults aged 18 years and over:

instead of a cigarette to help you manage your cravings.

to a healthcare professional.

feeling faint.
seizures
stop
If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet, tell a healthcare
professional.

Cutting down with no immediate plans to stop

5. How to store NiQuitin Minis

Adults aged 18 years and over:
It is always best to stop smoking completely, but using NRT

Keep out of the reach and sight of children.
the last day of the month.
protect from moisture.

of a cigarette to help you manage your cravings. Cut down
possible.
It is best to stop smoking completely as soon as you feel able

fine coating of tablet dust inside.
be disposed of via wastewater or household waste.

Going without cigarettes for a short time
Adults aged 18 years and over:
NiQuitin Minis can help you manage your cravings so that

6. Further information
What NiQuitin Minis contain
The active substance is

such as children.

The other ingredients

hospital.
peppermint flavour, menthol flavour and magnesium
cigarette to help you manage your cravings. Continue to use

What NiQuitin Minis look like and the contents of the pack

It is best to stop smoking completely as soon as you feel able
or three containers in a blistercard or five containers in a
carton.
Marketing Authorisation Holder and Manufacturer

Once you have stopped smoking…
again to help you relieve these cravings - using NRT is always
better than smoking again.
a healthcare professional. They can advise you on how to get
the best results from further courses of NRT.

The manufacturer of NiQuitin Minis Mint Lozenges is

If you use more NiQuitin Minis than you should

e-mail customer.relations@gsk.com.
NiQuitin and the Minis

NiQuitin Minis,
If a child has used or eaten any of the lozenges, contact your
doctor or hospital emergency department immediately.
Symptoms of nicotine overdose in children include headache,
If you take too many lozenges,
doctor or hospital emergency department immediately.

This leaflet was last revised in February 2014.

4. Possible side-effects
side-effects. They are similar to those you might get from the
doses NiQuitin Minis have not been found to cause any
serious side-effects.

restlessness, increased appetite and insomnia may also be
related to withdrawal symptoms associated with giving up
Other side-effects

9.0pt
9.1pt

9545 (Data Matrix Code)

100%

N/A

9.0pt

OC.BC.SPEC.002

N

45L045E

GSK-IRL-Dungarvan (OC)-IEDOC

CH-United Kingdom-GBR; CH-UK Regulatory-GBR NiQuitin Mini Mint

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OC.LT.009

White Paper 45gsm

Offset
K

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NiQuitin Minis
Mint 1.5 mg & 4 mg lozenges
Nicotine
Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use
NiQuitin Minis carefully to get the best results from them.
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).
Throughout this leaflet NiQuitin Minis Mint 1.5 mg and 4 mg Lozenges are
referred to as NiQuitin Minis.
In this leaflet:
1. What NiQuitin Minis do
2. Check before you use NiQuitin Minis
3. How to use NiQuitin Minis
4. Possible Side Effects
5. How to store NiQuitin Minis
6. Further Information

1. What NiQuitin Minis do
NiQuitin Minis are used to help people stop smoking. They work 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 NiQuitin Minis 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.
NiQuitin Minis 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, NiQuitin Minis can 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.
NiQuitin Minis can be used during pregnancy and breast-feeding (see Pregnancy
and Breast-feeding 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 NiQuitin Minis can help you stop. Any risks or
possible side-effects 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.

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 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 while
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 the 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 NiQuitin Minis
Adults and young people aged 12 years and over:
Instructions for use of NiQuitin Minis 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 have 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:
NiQuitin Minis Mint 4 mg Lozenges are for smokers who smoke more
than 20 cigarettes a day.
NiQuitin Minis Mint 1.5 mg Lozenges are for smokers who smoke fewer
than 20 cigarettes a day.
You should put one lozenge in your mouth and periodically move it from
one side of your mouth to the other, until it has completely dissolved. This
should take around 10 minutes.
Do not chew the lozenge or swallow it whole.
Do not use more than 15 lozenges a day.
NiQuitin Minis are 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.

2. Check before you use NiQuitin Minis
Do not use NiQuitin Minis:
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 aged under 12. 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 NiQuitin Minis
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 stop 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 ever had allergic reactions that involve swelling of the lips, face and
throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes
trigger this type of reaction.
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.
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CH-United Kingdom-GBR; CH-UK Regulatory-GBR NiQuitin Mini Mint

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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.
Start by using 8 – 12 lozenges a day. Suck a lozenge whenever you have an
urge to smoke.
Use the lozenges like this for up to 6 weeks, then gradually cut down the
number of lozenges you use a day.
Once you are using only 1 – 2 lozenges a day, try to stop using them
altogether.
To increase your chances of success 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 NiQuitin Minis to help
you cut down on smoking first.
When you feel a strong urge to smoke, have a lozenge instead of a cigarette
to help you manage your cravings. Cut down the number of cigarettes you
smoke per day by as many as possible. If you have not been able to 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 the future.
When you feel an urge to smoke, have a lozenge instead of 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:
NiQuitin Minis 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, have a lozenge instead of a cigarette to help
you manage your cravings. Continue to use one lozenge 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’.

Chest pain
Rash
Tiredness and generally feeling unwell
Very rare (affects less than 1 in 10,000 people)
Severe allergic reaction, symptoms of which include sudden wheeziness
or tightness of the chest, rash and feeling faint.
If you experience seizures (fits), stop taking this medicine.
If any of the side-effects get serious, or if you notice any side-effects not
listed in this leaflet, tell a healthcare professional.

5. How to store NiQuitin Minis
Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown on the container and
outer packaging. The expiry date refers to the last day of the month.
Keep all lozenges in the original container in order to protect from moisture.
Do not store above 30°C.
Do not use the container for anything else due to possible fine coating of
tablet dust inside.
Dispose of the container responsibly. 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 NiQuitin Minis contain
The active substance is nicotine. Each lozenge contains 1.5 mg or 4 mg (in the
form of a resin complex called nicotine resinate). The other ingredients are
mannitol (E 421), sodium alginate (E 401), xanthan gum (E 415), potassium
bicarbonate (E 501), calcium polycarbophil, sodium carbonate anhydrous
(E 500), acesulfame potassium (E 950), taste masking flavour, peppermint
flavour, menthol flavour and magnesium stearate (E 970b).

What NiQuitin Minis look like and the contents of the pack
White to off-white oval lozenges with convex surfaces.
The 1.5 mg lozenge has an “L” on one side. The 4 mg lozenge has an “F” on
one side.
Each container contains 20 lozenges. Packs may contain one or three
containers in a blistercard or five containers in a carton.

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 NiQuitin Minis Mint Lozenges is GlaxoSmithKline
Dungarvan Ltd, Knockbrack, Co. Waterford, Ireland.
If you have any questions or comments about NiQuitin Minis, please
FREEPHONE our Information Line on 0500 100 222 or e-mail
customer.relations@gsk.com.
NiQuitin and the Minis device are registered trade marks of the
GlaxoSmithKline group of companies.

Once you have stopped smoking…
After you have stopped smoking, you may still sometimes feel a craving for a
cigarette. You can use NiQuitin Minis 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.

This leaflet was last revised in February 2014.

If you use more NiQuitin Minis than you should
If a child has used or eaten any of the lozenges, contact your doctor or
hospital emergency department immediately. If possible, show them the
NiQuitin Minis packet or this leaflet. Symptoms of nicotine overdose in
children include headache, sickness, stomach pain and diarrhoea.
If you take too many lozenges, you may start to feel sick, dizzy and unwell.
Stop using the lozenges 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 NiQuitin Minis have not been found to cause
any serious side-effects.
Stopping smoking itself can cause some symptoms such as dizziness,
headache, sleep disturbance, cough and cold-like symptoms. Symptoms
such as depression, irritability, anxiety, restlessness, increased appetite and
insomnia may also be related to withdrawal symptoms associated with
giving up smoking.
Other side-effects are listed below – they are grouped based on the
likelihood with which they can occur.
Very common (affects more than 1 in 10 people)
The lozenges may cause your mouth or tongue to be slightly sore or irritated.
You may also feel sick.
Common (affects between 1 in 10 and 1 in 100 people)
Sore throat
Being sick
Stomach discomfort
Diarrhoea
Indigestion/heartburn
Flatulence
Hiccups
Less common side-effects (affects between 1 in 100 and 1 in 1000 people)
Nervousness
Depression
Palpitations (feeling your heartbeat)
Increased heartbeat

45L046E

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9535 (Data Matrix Code)

90%

N/A

7.0pt

OC.BC.SPEC.003

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45L046E

GSK-IRL-Dungarvan (OC)-IEDOC

CH-United Kingdom-GBR; CH-UK Regulatory-GBR NiQuitin Mini Mint

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OC.LT.010

White Paper 45gsm

Offset
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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.

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