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NIQUITIN PRE-QUIT 4 MG MINT LOZENGE

Active substance(s): NICOTINE RESINATE / NICOTINE RESINATE

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Nicotine Omega 2mg & 4mg Mint Lozenges
Please read right through this leaflet before you start using this medicine. This medicine is available
without prescription, but you still need to use Nicotine Omega Mint Lozenges 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).
In this leaflet:
1 What Nicotine Omega Mint Lozenges do
2 Check before you use Nicotine Omega Mint Lozenges
3 How to use Nicotine Omega Mint Lozenges
4 Possible side-effects
5 How to store Nicotine Omega Mint Lozenges
6 Further information
1. What Nicotine Omega Mint Lozenges do
Nicotine Omega Mint Lozenges 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 Nicotine
Omega Mint Lozenges 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 Omega Mint Lozenges 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 Omega Mint Lozenges 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 Omega Mint Lozenges 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 Nicotine Omega Mint Lozenges 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.
2. Check before you use Nicotine Omega Mint Lozenges
Do not use Nicotine Omega Mint Lozenges:
• if you have ever had an allergic reaction to nicotine, or any of the other ingredients (listed in
Section 6).
• if you are allergic to peanut or soya. The flavouring in Nicotine Omega Mint Lozenges contains soya
protein.
• 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 Omega Mint Lozenges
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.
• if you are on a low sodium diet. Each lozenge contains about 15 mg sodium and the maximum
daily dose (15 lozenges) contains 225 mg sodium. The maximum daily dose may be harmful if you
are on a low sodium diet.
• if you have phenylketonuria. The lozenges contain aspartame, a source of phenylalanine which
may be harmful to you if you suffer from phenylketonuria.
• if you have been told by your doctor that you have an intolerance to some sugars. The flavouring in
Nicotine Omega Mint Lozenges contains lactose.
• Nicotine Omega Mint Lozenges contain mannitol which may cause a mild laxative effect.
• 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 secondhand 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 Nicotine Omega Mint Lozenges
Adults and young people aged 12 years and over
Instructions for use of Nicotine Omega Mint Lozenges 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:
• Nicotine Omega4 mg Mint Lozenges are for smokers who smoke within 30 minutes of waking.
• Nicotine Omega2 mg Mint Lozenges are for smokers who smoke more than 30 minutes from
waking.
• 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 20 to 30 minutes.
• Do not chew the lozenge or swallow it whole.
• Do not use more than 15 lozenges a day.
Nicotine Omega Mint Lozenges are not suitable for children under 12 years of age or for nonsmokers.
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.
• Start by using at least 9 lozenges a day (maximum 15). 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, 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 Omega Mint Lozenges to help you
cut down on smoking first.
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. 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 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:
Nicotine Omega Mint Lozenges 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’.
Once you have stopped smoking…
After you have stopped smoking, you may still sometimes feel a craving for a cigarette. You can use
Nicotine Omega Mint Lozenges again to help you relieve these cravings – using NRT is always better

than smoIf 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.
If you use more Nicotine Omega Mint Lozenges 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 Nicotine Omega Mint Lozenges 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 Nicotine Omega Mint Lozenges 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, depression, irritability, anxiety and night-time awakening.
Other side-effects may include
• Very rare: Severe allergic reaction symptoms which include sudden wheeziness or tightness of the
chest, rash and feeling faint.
Stop taking the lozenge and tell a healthcare professional if you get these.
• Feeling/being sick, hiccups, burping, wind, feeling bloated, diarrhoea, constipation.
• Difficulty swallowing, dry mouth/throat/lips, sore throat, mouth irritation, ulcers in/around mouth.
• Indigestion, heartburn, bad breath, increase in saliva, shortness of breath.
• Bad dreams, restlessness, lack of energy, alertness, migraine.
• Tight chest, chest pain, stomach pains, changes in appetite, taste changes.
• Rash, itchy skin, hot flushes, feeling unwell.
• Seizures (fits), stop taking this medicine if you experience seizures.
Tell a healthcare professional if you get any of these.
If you do get any side-effects, even those not mentioned in this leaflet, tell a healthcare professional.
5. How to store Nicotine Omega Mint Lozenges
• Keep out of the reach and sight 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 lozenges 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 Omega Mint Lozenges contain The active substance is nicotine. Each lozenge contains
2 mg or 4 mg (in the form of a resin complex called nicotine resinate).
The other ingredients are mannitol (E 421), sodium alginate, xanthan gum, potassium bicarbonate,
calcium polycarbophil, sodium carbonate, aspartame (E 951), magnesium stearate and spearmint
flavour (contains lactose and soya protein).
What Nicotine Omega Mint Lozenges look like and the contents of the pack
White, round lozenges with convex surfaces. The 2 mg lozenge has “NL2S” on one side. The 4 mg
lozenge has “NL4S” on one side.
Packs contain 36 or 72 lozenges.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V
2SA, UK and all enquiries should be sent to this address.
The manufacturer of Nicotine Omega Mint Lozenges is
FAMAR A.V.E. ANTHOUSSA PLANT, Anthoussa Avenue 7, Anthoussa Attiki, 15344, Greece.
Nicotine Omegais a registered trade mark of ELAN PHARMA INTERNATIONAL LTD.
[Omega logo]
This leaflet was last revised in January 2016.

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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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