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NIQUITIN MINIS ORANGE 1.5 MG LOZENGES

Active substance(s): NICOTINE

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Orange 1.5 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 Orange 1.5 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 breastfeeding (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]

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 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.

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 Orange 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.

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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 when
ever 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.

Reporting of side-effects

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

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
• 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.
Also you can help to make sure that medicines remain as safe
as possible by reporting any unwanted side-effects via the
internet at www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy.

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.

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.
6. Further information
• when smoking should be avoided, such as before surgery.
When you feel an urge to smoke, have a lozenge instead of a
What NiQuitin Minis contain
cigarette to help you manage your cravings. Continue to use
The active substance is nicotine. Each lozenge contains
one lozenge every 1 – 2 hours (maximum 15 a day) during the
1.5 mg (in the form of a resin complex called nicotine
period when you are avoiding smoking.
resinate). The other ingredients are mannitol (E 421), sodium
It is best to stop smoking completely as soon as you feel able
alginate (E 401), xanthan gum (E 415), potassium bicarbonate
to. Follow the instructions above, under ‘Stopping smoking
(E 501), calcium polycarbophil, sodium carbonate anhydrous
straightaway’.
(E 500), acesulfame potassium (E 950), orange flavour,
Once you have stopped smoking…
peppermint flavour and magnesium stearate (E 970b).
After you have stopped smoking, you may still sometimes
What NiQuitin Minis look like and the contents of the pack
feel a craving for a cigarette. You can use NiQuitin Minis
White to off-white oval lozenges with convex surfaces.
again to help you relieve these cravings - using NRT is always
The 1.5 mg orange lozenge has a “J” on one side. Each
better than smoking again.
container contains 20 lozenges. Packs may contain one or
If you are worried that you may start smoking again, talk to
three containers.
a healthcare professional. They can advise you on how to get
Marketing Authorisation Holder and Manufacturer
the best results from further courses of NRT.
The Marketing Authorisation holder is GlaxoSmithKline
If you are finding it difficult to stop using NRT completely,
Consumer Healthcare, Brentford, TW8 9GS, U.K. and all
talk to a healthcare professional.
enquiries should be sent to this address.
The manufacturer of NiQuitin Minis Orange Lozenges
If you use more NiQuitin Minis than you should
is GlaxoSmithKline Dungarvan Ltd, Knockbrack, Co.
If a child has used or eaten any of the lozenges, contact your
Waterford, Ireland.
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.
If you have any questions or comments about NiQuitin Minis,
please FREEPHONE our Information Line on 0500 100 222 or
4. Possible side-effects
e-mail customer.relations@gsk.com.
Like all medicines, the nicotine in NRT products can have
NIQUITIN and the MINIS device are trade marks of the
side-effects. They are similar to those you might get from the
GlaxoSmithKline group of companies.
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,
This leaflet was prepared in February 2014.
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.

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Dungarvan Additional Information Panel
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TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9pt

N/A

Leading: 9.1pt

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Horizontal Scale: 100%
Smallest text size: 9pt

OC.BC.SPEC.002

Microtext: N

DEVCOMP-0003465

GSK-IRL-Dungarvan (OC)-IEDOC

CH-United Kingdom-GBR;
CH-UK Regulatory-GBR

NiQuitin Mini Orange

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OC.LT.009

Offset

White paper 45GSM

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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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