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NiQuitin Minis'

Cherry Flavour 1.5 mg & 4 mg lozenges

Nicotine

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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 advisorqr pharmacist).______

Throughout this leaflet NiQuitin Minis Cherry Flavour 1.5 mg & 4 ‘    ‘ ‘ Minis.

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In this leaflet:

1.    What NiQuitin Mipis do

2.    Check before youiuse NiQuitin Minis

3.    How to use NiQuitin Minis

^/4. Possible side-effects

...

mg Lozenges are referred to as NiQuitin i

5. How to store NiQpitin Minis 5. Further information

. 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

.^mpkershave. When .they try .to give upj________________

NiQuitin Minis <lan be used to help youJ

•    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 stroking is prohibited (temporary abstinence).

•    develop cravings once you have stopped smoking.

'/ Reducing the number of cigarettes smoked can increase the / chances that yojj will go on to quit completely.

NiQuitin"Mfnis carTbe~used during pregnancy aricTbreastfeeding (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 helpyou 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' j

. programmes, ate known as behavioural support. For more___j.

information:

•    call the NHS Free Smoking Helpline on 0800 022 4332, or visit http://www.smokefree.nns.uk [or the Irish National Smokers Quitiine on 1850 201 203]

° if you have diabetes. When you start using NRT, you need to monitor your plood 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 " ‘    ' B-effer    "

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jmour (phaeochromocyton nicotine may make your symptoms worse.

may be more likely to get side-effects. |

• if you have uncontrolled overactive thyroid gland or an — adrenal gland tumour (phaeochromocytoma), because

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 injvolve 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).

■Aff-yott ere 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 yob are pregnant Is harmful to the baby. The risks include poor growth before birth, damage to the baby': lungs, premature birth and stillbirth. Stopping smoking is tn< best way to Improve your health and the and the earlier you stop smoking the better.

ing smoking is the ealth of your baby,

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 tp 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 tp 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.

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Stopping smoking straightaway j Adults and young people aged 12 years and over: it is important to make every effort to stop smoking completely. Butj if you do sometimes smoke a cigarette while using NRT, don't be discouraged —just keep going with your

Very common (affects more than 1 in 10 people)

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• if you have eyer had an allergic reaction to nicotine, or any

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• or visit http:/, a free online

/www.niqi Support plan.

uitin.co.uk for information about

2. Check before you use NiQuitin Minis

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•    If you can use them, NRT gum or lozenges are better than

I If you are breast-feeding

¹ Tobacco smoke is harmful to babies and children, causing breathing difficulties and other problems, j

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 vyhile 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 yoiir body all the time. -

•    Try to breast-feed just before you take thel 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

f

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of the other ingredients (listed in Section 6).

___■ if you are jj non-smoker.________j________________i

•    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.

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Take special care with NiQuitin Minis ]

Set 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.” I    _\_

**

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FRONT

8mm

8mm

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BACK

Adults and young people aged 12 yeirs

Instructions for use of NiQuitin Minis depenc are:

•    stopping smoking straightaway.

■ cutting down on smoking before you stop.

•    cutting down with jtoimmediate jjjans Jo 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 k to a healthcare professional for advice.

and over

nd on whether you

straight away, tal In all cases:

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» NiQuitin Minis Cherry Flavour 4 mg Lozengek are for smokers who smoke more than 20 cigarettes a day.

• NiQuitin Minis Cherry Flavour 1.5 mg Lozenges are for smokers who smoke fewer than 20 cigarettes a day. ;

t on

•    You should put One lozenge in your mouth and periodically

move it from one side of your mouth to the other, until rt has completely dissolved. This should takje around 10 minutesT------j-----------

•    Do not chew the lozenge or swallow it whole.

•    Do not use more than 15 lozenges a dayi

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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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 behaviours! support programme - see the end of Section 1 for more details.

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

You may find itieasier to quit completely later if you use NiQuitin Minis to help you cut down or) 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 smoTce per day by as many as-possib(er1f 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

a quit

,    „    , 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 makeit easier to quit completely irt-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.

If 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 ian help you manage your cravings so that you can resist cigarettes in situations where smoking is inappropriate, for example:

•    where your sqcond-hand smoke may damage other people, such as children.

•    where smokirig 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, havea lozenge instead of a cigarette to help you manage your crayings. 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, undo' 'Stopping smoking straightaway*.    “

Once you have stopped smoking... —.----------------

After you have stopped smoking, you rfiay 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 howto 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.

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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, showthem the NiQuitin Minis packet or this leaflet. Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea.

if you take too ihany 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 foynd to cause any serious side-effects.

Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep disturbance, icough 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.

•    The lozenges may cause your mouth 6r tongue to be slightly sore of irritated. You may also] feel sick.

Common (affects between 1 in 10 and 1 ifi 100 people)

•    Sore throat

•    Being sick

•    Stomach discomfort

Diarrhoea

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•    Indigestion/hejartburn

. _• Fifty fence____j_______________J_____________

•    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 unwe|l Very rare (affects less than 1 in 10,000 people)

•    Severeal rerguf reaction, sym'ptonis'ofTwfiichTriclude

sudden wheeziness or tightness of the chest, rash and feelinq faint. •    !

If you experience seizures (fits), stop taking this medicine.

you notice any

If any of the side-effects get serious, or if yi side-effects not listed in this leaflet, tell a n professional

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5. How to store NiQuitin Minis

ealthcare

•    Keep out of the reach and sight of children.

•    Do not use this fnedicine after the 'EXP'; date shown on container and outer packaging. The expiry date refers to the last day of the month.

•    Keep ail lozenges in the original container in order to ’“protect from moisture.

•    Do not store above 30°C.

•    Do not use the Container for anything ejlse due to possible fine coating of tablet dust inside. j

•    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 tozbnge contains Tr5— / mg or 4 mg (in the form of a resin complex called nicotine ^A resinate). The other ingredients are manrjttol (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, cherry flavour and magnesium stearate (E 970b).

What NiQuitin Minis look like and the contents of the pack White to off-whitfe oval lozenges with convex surfaces.

The 1.5 mg lozenge has a "C" on one sid4. The 4 mg lozenge has a "T" on one side.

Each container contains 20 lozenges. Packs may contain one or three containers.

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.

■iW.

The manufacturer of NiQuitin Minis Cherry Flavour Lozenges is GlaxoSmithKline Dungarvan Ltd, Knockbtack, Co. Waterford,

Ireland.    j    |

NiQuitin and the Minis device are registered trade marks of ELAN PHARMA INTERNATIONAL LTD.

OMEGA

PHARMA

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This leaflet was last revisedfiffQdtbber 20|15.

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Other side-effects are listed below - they are grouped based on the likelihood with which they can occur.

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