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NiQuitin Minis

Cherry Flavour 1.5i

Very common (affects more than 1 in 10 fbeople)

2*

i

i

Please read right thijough this leaflet befor^ 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 fuifther questions, ask a healthcare professional

-(doctor;.nurse, sraojciog.cessation advisor njr pharmacist).______

•    Throughout this leiaflet NiQuitin Minis Cherry Flavour 1.5 mg &4 mg Lozenges are referred to as NiQuitin Mims.

In this leaflet:

1.    What NiQuitin Mipis do

2.    Check before youjuse NiQuitin Minis

3.    How to use NiQuijtin Minis

4.    Possible side-effects

5.    How to store NiQuitin Minis

6.    Further information

2

I

. What NiQuitin Minis do

NiQuitin Minis are used to help people 'stop smoking. They work by replacing some of the nicotinejyou get from cigarettes. This jtype of treatment is calljed Nicotine Replacement Therapy (|SIRT).

The nicotine in cigarettes makes them addictive, but other substances in cigarette smoke, such as tjar, carbon dioxide and other toxins, arp more harmful to your jhealth. NRT products like NiQuitin Minis do not have the health dangers of tobacco.

The nicotine frdm NRT reduces your crajvings for cigarettes and helps you rpsist the urge to smoke.] It also relieves some of the unpleasant symptoms (like feeling ill or irritable) that

___smokers iiave.vstheD.they_try.tQ-give. up.]_______________

NiQuitin Minis clan be used to help you]

•    stop smoking (straightaway (a quit attempt).

•    cut down on slmoking, perhaps before you go on to stop completely (reducing to quit or just t^ducing).

In addition, NiQuitin Minis can be usedjwhen you:

•    do not wish to smoke or are unable to smoke, for example in confined spaces (in the car, in the hpuse), where others (such as children) could be harmed bvjtobacco smoke or in places where sjmoking is prohibited (temporary abstinence).

•    develop cravirjigs once you have stopped smoking.

Reducing the number of cigarettes smoked can increase the chances that yo]u will go on to quit corrjpletely.

NiQuTtirTM fnislFarTbe^- used^urTng^ pi^^ancy llncT breast-^— feeding (see Pregnancy and Breast-feeejing below).

Some people wbrry that, when they hape stopped smoking, they may become dependent on NRT instead. This is very rare, ana if it were t6 happen it is still safer than continuing to smoke. It is also] an easier habit to breajc.

mg & 4 mg lozenges

Nicojtine

i    i

•    if you have diabetes. When you start usipg NRT, you need to monitor your Iplood sugar levels morejorten than usual, because your dosie of medication for diabetes may need to be adjusted.

•    if you have seriojus liver or kidney problems, because you may be more likqly to get side-effects.

---•-if you have uncontrolled overactive thyroid gland-or an—

adrenal gland tumour (phaeochromocytoma), because nicotine may maljte your symptoms worsq.

•    if you have stomjach or duodenal ulcers br inflammation of the oesophagus gr gullet (the passage between the mouth and stomach) because swallowing nicotine can make your symptoms worse] It may also cause moutp ulcers. If your

3toms do gel] worse you should talk |o your doctor. You t want to usje a non-oral form of NRT instead, such as patches.

if you have had^jillergic reactions that involve swelling of . Usint

eaction.

[throat (angioedemaj or itchy skin rash

■ this type of

It is always better to stop smoking completely. Smoking is harmful and has no health benefits. NRT products like NiQuitin Minis <tan help you stop. Any disks or possible itinefro

side-effects of rjicotine from NRT are m]uch less than the proven dangers of continuing to smoke.

Your chance of Stopping smoking will l!>e improved if you also take part ih a support programme! These 'Stop Smoking'

__programmes arp known as hehavioura^support. £ar_more___

information:

• call the NHS Free Smoking Helpline oil 0800 022 4332, or visit http://wvlrw.smokefree.nns.uk [or the Irish National Smokers Quitljne on 1850 201 203] or visit http://jwww.niquitin.co.uk for] information about : support plan.

a free online

2. Check before you use NiQuitin Minis

&

*

Do not use NiQluitin Minis:

•    if you have ev{er had an allergic reactijon to nicotine, or any of the other ingredients (listed in Section 6).

•_if_you arejj njn^smoker.

•    if you are agejd under 12. The level of] nicotine in NRT is not suitable for children under 12. Children are more susceptible to the effects if nicotine, and it could]cause severe toxicity, which can be fjatal.

i    i

Take special carle with NiQuitin Minis ]

Get help and advice from a healthcare professional:

•    if you are in hjospital because you ha\|e had a heart attack, severe heart rhythm disturbances or a stroke. Try to stop smoking without NRT unless your doctor has tola you to use it. Once you are discharged from hospital, you can use NRT as normal.

••••<

••••<

••••<

••••<

••••<

FRONT

8mm

8mm

luiugi.

E

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CO

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the lips, face an

(urticaria). Using ]NRT can sometimes trigger _reaction.

^J-yotf are taking-other medicines----!-------------

Stopping smoking!may alter the effect of (other medicines you may be taking.

If you have any questions or concerns abojut this, talk to a healthcare professional.

Pregnancy and tlreast-feeding If you are pregnarlt or planning to becomk pregnant Smoking when yo!u are pregnant is harmful to the baby. The

risks include poor (growth before birth, dalmage to the baby's lungs, premature birth and stillbirth. Stopbing smoking is the best way to improve your health and the health of your baby, and the earlier yob stop smoking the bettfer.

Jt is best to give ub smoking without^us[nlg_NRT. Jf that's tc difficult, usingTIRTissaferToryou andyo|u r baby than continuing to smoke. The nicotine in NRT'is less dangerous than the more harjmful substances in cigarette smoke, such as tar and other toxiijis.

If you have tried tj> stop smoking without! using NRT, and haven't been able'to, your healthcare advisor may recommend NRT to helpjyou stop. If you do usejNRT during pregnancy:

•    Start as early in ^our pregnancy as possible.

•    Aim if possible ti> 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 th|sm, NRT gum or lozengps are better than

- patches. That's bic-ause-you-wi 11 not be absorbing nicotine - -into your body al!l the time. But if you feel sick, you may need to use NRT patches instead.

If you are breast-jfeeding

Tobacco smoke is harmful to babies and children, causing breathing difficulties and other problems. ]

If you are breast-febding, it is best if you stob smoking without using NRT. But if you do need to use NRT, the nicotine that gets into breast milk is Ibss dangerous to your baby than breathing in second-hand smokq.

If you do use NRT vj/hile 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,

-youwHHrot-be-ablsorbing nicotine-irrto^yodrr-body-aHtheTimeT-

•    Try to breast-feed just before you take thei gum or lozenge, when the nicotine) levels in your body are e)t their lowest. That way, your baby gdts as little nicotine as possible.

3. Howto use NiQuitin Minis

Stopping smoking straightaway Adults and youhg people aged 12 yearjs and over:

It is important to make every effort to itop smoking completely. But] if you do sometimes srrjoke a cigarette while using NRT, don't be discouraged —just! keep going with your quit attempt. It]may help to talk to a hbalthcare professional if you are findirjig your quit attempt difficult.

•    Start by using]8 - 12 lozenges a day. Sjuck a lozenge when ever you haveian urge to smoke.

•    Use the lozenges like this for up to 6 l/veeks, then gradually cuttownjhejiurnberof Jozengesyod use ad ay. _

•    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 detail*.

Cutting down] on smoking before y]ou stop Adults aged 18]years and over:

You may find itieasier to quit completely later if you use NiQuitin Minis jo help you cut down orj smoking first.

When you feel b strong urge to smoke,] have a lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smblce per day by as -ma

•    The lozenges (nay cause your mouth dr tongue to be slightly sore of irritated. You may alsojfeel sick.

Common (affects |oetween 1 in 10 and 1 ifi 100 people)

•    Sore throat

•    Being sick

•    Stomach discomfort

• Diarrhoea

I

•    Indigestion/heartburn

•    Flatulence

• Hiccups

Less common sidel-effects (affects betweeh 1 in 100 and 1 in

1000 people)

•    Nervousness

•    Depression

•    Palpitations (feeling your heartbeat)

•    Increased heartbeat

I

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2

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Adults and young people aged 12 years and over

Instructions for use of NiQuitin Minis depend on whether you are:

i    i

•    stopping smokinlg straightaway.

•    cutting down on| smoking before you stop.

•    cutting down with jnojmmediatejDlans tjc^stop._________

•    going without cigarettes for a short timg.

or if you have cravjings after you have stopped smoking.

If you are under 18 years old and not ready to stop smoking straight away, talk to a healthcare professional for advice.

In all cases:

•    NiQuitin Minis Cherry Flavour 4 mg Lozengejs are for smokers who smoke more than ^0 cigarettes a day.

•    NiQuitin Minis Cherry Flavour 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 ond side of your mouth to the other, until it has completely djssolved. This should takje around 10

--mintrtesr------■----------------■-------------

•    Do not chew the! lozenge or swallow it whole.

•    Do not use morel than 15 lozenges a day!

| NiQuitin Minis are! not suitable for childre^i under 12 years of | age or for non-smpkers. They may develop signs of nicotine overdose, including headache, sickness, stbmach pain and diarrhoea.

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IiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiIiiiiI

Measurement Bar (mm)

9272

JOB STATUS: REPRO

ny-as-pessibijeHf you-bave-not-been-jable-te 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 ablelto make a quit attempt within l6 months of starting tojuse NRT, you may find it helpful to taljc to a healthcare professional.

Cutting down] with no immediate plans to stop

I    i    i

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 - wHI- make- rt-easTieF-1e-quit completely ih-futuFe.-----------

When you feel pn urge to smoke, haveja lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per da|y by as many as possible.

It is best to stop smoking completely a* soon as you feel able to. Follow the instructions above, under 'Stopping smoking straightaway'. ]

| Going without cigarettes for a short time Adults aged 18lyears and over:

NiQuitin Minis dan help you manage ydur cravings so that you can resist cigarettes in situations wherel smoking is inappropriate, for exarrjiple:

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

•    where smokirlg is not allowed, such a]s on a flight or in a hospital.

•    when smoking should be avoided, suifh as before surgery.

i    i

When you feel bn urge to smoke, have la 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 ydu are avoiding smoking.

It is best to stop smoking completely a* soon as you feel able to. Follow the instructions above, under 'Stopping smoking straightaway'. !

Once you have stopped smoking...---1----------------

After you have Istopped smoking, you rliay still sometimes feel a craving for a cigarette. You can use NliQuitin Minis again to help you relievq these cravings - using ^IRT is always better than smoking again.

If you are worried that you may start srlnoking again, talk to a healthcare professional. They can advisfe you onflow to get the best resultsjfrom further courses of]NRT.

If you are findirjig it difficult to stop usihg NRT completely, talk to a healthcare professional.

If you use moj'e 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

■ po55tblershow"therrrth^ NiQcriti rrMirrisj-packefor this ■feaftetr 7 Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea. ]

If you take too i^any 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 medicinjes, the nicotine in NRT products can have side-effects. They are similar to those ypu might get from the nicotine in cigarettes, and are more likply the more nicotine you take, but npt everybody gets them] At the recommended aoses NiQuitin Minis have not been found to cause any serious side-effects"

Stopping smoking itself can cause som4 symptoms such as dizziness, headpcne, 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.

I    I

•    Chest pain

•    Rash

•    Tiredness and (generally feeling unwe|l Very rare (affects less than 1 in 10,000 pebple)

•    Sev^re^llergTJT^acfibrT/sym^foms^TlwhTchThcrude sudden wheezjiness or tightness of the] chest, rash and feeling faint. .

If any of the side-(effects get serious, or if you notice any side-effects not lifted in this leaflet, tell q healthcare professional.

5. How to store NiQuitin Minis

2

•    Keep out of the!reach and sight of children.

•    Do not use this Inedicine after the 'EXP*! date shown on the container and oiliter packaging. The expiry date refers to the last day of tlje month.

•_Keep_all lozengesjn the_orjginal contaifierjn order to _ p’rotect from moisture."

•    Do not store ab[>ve 30°C.

•    Do not use the (jontainer for anything e(lse due to possible fine coating of tpblet 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 rjiedicines no longer required. These pleasures will help to prptect the environment.

6. Further information

t

What NiQuitin K/linis contain

The-active-substaliceis-nicotine. Each-lozknge-contatnsTr5- — mg or 4 mg (in thb form of a resin complex called nicotine resinate). The othjer ingredients are manhitol (E 421), sodium alginate (E 401), xanthan gum (E 415), potassium bicarbonate (E 501), calcium pblycarbophil, sodium carbonate anhydrous (E 500), acesulfamje potassium (E 950), tasjte masking flavour, cherry flavour and magnesium stearate (E 970b).

What NiQuitin Minis look like and the contents of the pack

White to off-whitle oval lozenges with convex surfaces.

The 1.5 mg lozendje has a "C" on one sidi. The 4 mg lozenge has a "T" on one fide.

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

Marketing Authorisation Holder and Manufacturer_______^

The Marketing Authorisation holder is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GjS, U.K. and all enquiries should be sent to this address. ■

The manufacturenof NiQuitin Minis Cherry Flavour Lozenges is GlaxoSmithKline ibungarvan Ltd, KnockbSack, Co. Waterford,

-e-

Ireland.

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If you have any questions or comments about NiQuitin Minis, please FREEPHONE our Information Line on 0500 100 222 or e-mail customer.r4iations@gsk.com.

NiQuitin and the Minis device are registefed trade marks of the GlaxoSmithKIjne group of companies]

#c

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GlaxoSmithKline

8mm

This leaflet was last revised irftRubber

ID

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<£? SCHAWK!

GlaxoSmithKline

production proof approval

Schawk, Kingsway North, Newcastle, Tyne & Wear NE11 OJH, UK. T+44 (0) 191 491 7777 F+44 (0)191 487 6673

V2 06Nov2008

DATE

□    BRAND MANAGER _□_

□    PACXPERIENCE / PDD_□_

□    REGULATORY_□_

□    P.C.M--□_

PRIORITY ®(2)(3)

GlaxoSmithKline

FOR CONTENT ONLY

Please refer to existing colour standard.

GlaxoSmithKline

GSK Drawing No.: L629D014/02 Dimensions:    204 x 305 mm

Factory:    Dungarvan

Component:    Leaflet

Date:    31 May 2008

Profile Keys:

Print Free

Glue Area

Front Panel Bleed Area

204mm

N\\\\\\\\\\\^\\\\\\\\\\\\i\\\\\\\\\\\\K\\\\\\\\\\\\

NiQuitin Minis

Cherry Flavour 1.5 mg

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

•    Keep this leaflet. You may need to reaijl it again.

•    If you have any further questions, ask a healthcare professional (doctor, nurse, smoking cessation advisor or pharmacist).

•    Throughout this leaflet NiQuitin Minis |Cherry Flavour 1.5 mg & 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.    Flow to use NiQuitin Minis

4.    Possible side-effects

5.    Flow to store NiQuitin Minis

6.    Further Information

1. What NiQuitin Minis do

& 4 mg lozenges

Nicotine

305mm

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 therrj addictive, but other substances in cigarette smoke, such as tar, carbon dioxide ang other toxins, are more harmful to your health. NRT products like NiQuitin Minis do n|ot 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 the^ 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 usep 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 fjave 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 hjlinis 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 wil| 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 NFiS Free Smoking Fielpline on 0800 022 4332, or visit http://www.smokefree.nhs.uk [or the Irish National Smokers Quitline on 1850 201

203]

I

• or visit http://www.niquitin.co.uk fbr information about a free online support plan.

2. Check before you use NiQuitin Minis

Do not use NiQuitin Minis:

I

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 babyfs 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 thle better.

It is best to give up smoking without usirjg 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 1|o 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 S months. But remember — the most important thing is not to smoke. It is safer to carry on using NRT than to start smoking again.

' «lf yoifcan use them, NRT gu'mor lozenges areBetferthan pafcheT 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 getf 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 jo 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 tlfie 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. Howto 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.

I

• if you are aged under 12. The level yf nicotine in NRT is not suitable for children under 12. Children are more susceptible to the effects of nicotine, and it could t3use_seyere toxjcjty_Lwhich_canbe jataL.

Adults and young people aged 12 y£ars 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 once you have stopped smoking.

iiyouiirejjDder.l&yeaoLQld and not ready to stop smoking straightaway, talk to a _ healthcare professional for advice.

In all cases:

•    NiQuitin Minis Cherry Flavour 4 mg Lozpnges 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.

•    You should put one lozenge in your mojith 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 Jvhole.

•    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 hicotine 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 stqp 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. I

•    Start by using 8-12 lozenges a day. Sucjc a lozenge whenever you have an urge to smoke.

•    Use the lozenges like this for up to 8 w^eks, then gradually cut down the number of lozenges you use a day.

X

-8mm

"I

• 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

I programme - see the end of Section 1 for more details.

Cutting down on smoking befori you stop

Adults aged 18 years and over:

You may find it easier to quit compleljely later if you use NiQuitin Minis to help you cut down on smoking first.

When you feel a strong urge to smokfe, 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 bpen 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 straightawdy'. If you have not felt able to make a quit attempt within 6 months of starting tp use NRT, you may find it helpful to talk to a healthcare professional.

jcutting 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 hejavily. 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, havje 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'.

jGoing without cigarettes for a short time

Adults aged 18 years and over:

NiQuitin Minis can help you manage four 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, suchjas on a flight or in a hospital

•    when smoking should be avoided, such as before surgery.

When you feel an urge to smoke, havt 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 sijnoking straightaway'.

Once you have stopped smokingj...

After you have stopped smoking, you!may still sometimes feel a craving for a cigarette. You can use NiQuitin Minis bgain to help you relieve these cravings - using NRT is always better than smoking again.

If you are worried that you may startjmoking 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 uting NRT completely, talk to a healthcare professional.

I If you use more NiQuitin Minis than you should

If a child has used or eaten any of thd lozenges, contact your doctor or hospital emergency department immediately. [If possible, show them the NiQuitin Minis - jacket or this leaflet. Symptoms of nijotine overdose in children include headache, lickness, stomach pain and diarrhoea.j

' f you take too many lozenges, you may start to feel sick, dizzy and unwell. Stop Hising the lozenges and contact your doctor or hospital emergency department immediately.

4. Possible side-effects

Like all medicines, the nicotine in NRlj products can have side-effects. They are similar to those you might get from the nicojine 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 fiund to cause any serious side-effects.

Stopping smoking itself can cause sorjie 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.

ir-triey are grouped based on the likelihood with

I

Other side-effects are listed below . which they can occur.

Very common (affects more than 1 in [10 people)

•    The lozenges may cause your moluth 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

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.lMedicines should not be disposed of via wastewater or household waste. Ask[your pharmacist how to dispose of medicines no longer required. Thesejmeasures will help to protect the environment.

6. Further information

I

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 polycarbofchil, sodium carbonate anhydrous (E 500), acesulfame potassium (E 950), taste masking flavour, cherry flavour and magnesium stearate (E 970b).

What^i(^itjr^MjnisJoo]dike_an«J the contents of thejjack_

White to off-white oval lozenges with [convex surfaces.

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

Each container contains 20 lozenges. Phcks may contain one or three containers. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder islGlaxoSmithKIine Consumer Healthcare, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer of NiQuitin Minis Cnerry Flavour Lozenges is GlaxoSmithKline Dungarvan Ltd, Knockbrack, Co. Watefford, Ireland.

If you have any questions or comments about NiQuitin Minis, please FREEPHONE our Information Line on 0500 100 222 jar e-mail customer.relationsegsk.com. NiQuitin and the Minis device are registered trade marks of the GlaxoSmithKline group of companies.

fGlaxoSmith Kline

This leaflet was last revised in November 2010.

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305mm

Take special care with NiQuitin Nlinis

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 overactivejthyroid 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 majuth 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 yoijr 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.

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•    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 4«n    [    ^

• Rash Z    I    IT

•    Tiredness and generally feeling unwell Very rare (amts less than 1 in 10,000 people)

•    Severe gjergic reaction, symptonlis of which include sudffii wheeziness or tightness of the chest, rash and fueling faint.

If any of the side-effects get serious, j>r if you notice any side-effects not listed in this leaflet, tell a healthcare professional.

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# SCHAWK!

GlaxoSmithKline

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V2 06Nov2008

DATE

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