4 mg Gum

nicotinechewing gum

06-0813

Personalised support programme

Enrol on the internet or callnow on 0800 244 838.

with

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A guide for usersWhat you should know about

nicorette® 4 mg Gum(4 mg nicotine chewing gum)Full strength

nicorette® Mint 4 mg Gum(4 mg nicotine chewing gum)Full strength

nicorette® Freshmint 4 mg Gum(4 mg nicotine chewing gum)Full strength

Please read this leaflet carefullybefore you start using this medicine.It provides useful information onhow to use it safely. Keep theleaflet, you might need it again.If you think you are having side-effects, have any questions or are not sure about anythingplease ask your doctor, nurse orpharmacist.

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In this leaflet1 What this medicine is for page 4

2 Before using this medicine page 6n Do not use Nicorette Gum page 6n Talk to your doctor, nurse or

pharmacist page 6n Some of the ingredients can cause

problems page 8n If you are pregnant or

breast-feeding page 9

3 How and when to use this medicinepage 11n When to use Nicorette Gum page 11n How to chew Nicorette Gum page 14n How to stop smoking: your choice

page 15n Stopping Immediately: page 17

n Adults aged 18 years and overn Children aged 12 years and over

n Stopping Gradually: page 21 n Adults aged 18 years and overn Children aged 12 years and over

n If you have used too many gumspage 25

n If a child has used or swallowed the gums page 25

4 Possible side-effects page 262

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If you smoke more than 20cigarettes a day, this product willhelp relieve your cravings. If you smoke 20 or fewercigarettes a day, 2 mg nicotinegum may be more appropriate.

What does Nicorette Gum do?When you stop smoking, or cutdown the number of cigarettesyou smoke, your body misses thenicotine that you have beenabsorbing. You may experienceunpleasant feelings and a strongdesire to smoke (craving). Thisindicates that you weredependent on nicotine.When you chew Nicorette Gum,nicotine is released and passes intoyour body through the lining ofyour mouth. The nicotine releasedfrom the gum is sufficient torelieve the unpleasant withdrawalsymptoms. It will also help to stopthe craving to smoke, butNicorette Gum will not give youthe ‘’buzz’’ you get from smoking

5 Storing and disposal page 30

6 Further information page 31

7 Helpful tips on giving up page 33

8 Nicorette ActiveStop page 42

1 What this medicine is forNicorette Gum is a nicotinereplacement therapy (NRT).It is used to relieve withdrawalsymptoms and reduce the cravingsfor nicotine that you get whenyou try to stop smoking, or whenyou are cutting down the numberof cigarettes you smoke whiletrying to stop smoking.To help cut down or quit smokingyou should also try to use abehavioural support programmeto increase your chances ofsuccess. Details of NicoretteActiveStop are shown in Section 8of this booklet.

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use nicotine replacementtherapy (NRT) to help you giveup smoking but you should try to give up without it. Seepage 9 If you are pregnant orbreast-feeding.

n if you are in hospital becauseof heart disease (includingheart attack, disorders of heartrate or rhythm, or stroke).In other heart conditions notrequiring you to be inhospital, using NRT is betterthan continuing to smoke.

n if you have a stomach ulcer,duodenal ulcer, inflammationof the stomach orinflammation of theoesophagus (passage betweenthe mouth and stomach).

n if you have liver or kidneydisease.

n if you have an overactivethyroid gland or have aphaeochromocytoma (atumour of the adrenal glandthat can affect blood pressure)

a cigarette. Make sure you chewNicorette Gum correctly to get thebest effect – see ‘How to chewNicorette Gum – the NicoretteChewing Technique’. The benefits of stopping smokingfar outweigh any potential riskfrom using nicotine from NRT. It isthe toxins in cigarette smoke suchas tar, lead, cyanide and ammoniathat cause smoking related diseaseand death, not the nicotine.

2 Before usingthis medicineDo not use Nicorette Gum:n if you have an allergy to

nicotine or any of the otheringredients.

Talk to your doctor, nurse orpharmacist…n if you are pregnant or breast-

feeding – you may be able to6 7

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Freshmint 4 mg Gum do notcontain sorbitol.

n The chewing gum basecontains butylated hydroxytoluene (E321), an anti-oxidant. May cause local skinreactions (e.g. contactdermatitis) or irritation to theeyes and mucous membranes.

If you are pregnant orbreast-feedingIf you are pregnant: ideally, youshould try to give up smokingwithout NRT. If you can’t managethis, you can use NRT as the risksto your baby are far less thansmoking, however you should talkto your doctor, nurse or pharmacistfor advice. Products that are usedintermittently may be preferableto nicotine patches. However,patches may be more suitable ifyou have nausea or sickness.If you do use patches take themoff before going to bed at night.

– your doctor will have toldyou this.

n if you have diabetes – monitoryour blood sugar levels moreoften when starting to useNicorette Gum as you may findyour insulin or medicationrequirements alter.

n if you are taking othermedicines such astheophylline, clozapine orropinirole. Stopping smokingor cutting down may requirethe dose of these medicines tobe adjusted.

ä If any of these applies, talk toyour doctor, nurse or pharmacist.

Some of the ingredientscan cause problemsn Nicorette 4 mg Gum contains

sorbitol. If you have been toldby your doctor that you havean intolerance to some sugars,talk to your doctor beforetaking this medicine. NicoretteMint 4 mg Gum and Nicorette

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3 How and when to use this medicineWhen to use theNicorette GumsFollowing is the dosage informationfor the Nicorette Gums. This showsthe number of gums you shouldbe using, when you should takethem, how you should take themand the maximum amount of timeyou should be using NicotineReplacement Therapy (NRT) for.Please read this informationcarefully and then go to the “Howto stop smoking: your choice”section on page 15, which willhelp you decide which method touse to give up smoking.n Use the “How to chew Nicorette

Gum – the Nicorette ChewingTechnique” instructions whichfollow. The method of chewingis NOT the same as that forordinary chewing gum. This wayof chewing ensures that the

If you are breast-feeding: ideally,you should try to give up smokingwithout NRT. If you can’t managethis you are best to use NRTproducts that are takenintermittently (not patches),however you should talk to yourdoctor, nurse or pharmacist foradvice.

Breast-feed just before you useNicorette Gum to ensure that thebaby gets the smallest amount ofnicotine possible. If you do need to use NRT to helpyou quit, the amount of nicotinethat the baby may receive isconsiderably smaller and lessharmful than the second-handsmoke they would inhale if yousmoked. Tobacco smoke producesbreathing and other problems inbabies and children.

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Adults and Children 12years and over

nicotine is correctly releasedfrom the gum.

n The number of Nicorette Gumsyou use each day will depend onhow many cigarettes yousmoked and how strong theyare. See the dosing table to findout the dose you should take.

n The Nicorette 2 mg Gums areavailable in alternative packsand should be used if you smoke20 or fewer cigarettes a day.They can also be used when yougradually start to reduce thestrength and number of gumsyou use each day.

Children under 12 yearsDo not give this product tochildren under 12 years.

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• Use only one piece of gum at a time.• Most people use between 8 to 12

gums per day.• Do not use more than 15 gums per day.• Children aged 12 up to 18 years should

not use for longer than 12 weekswithout asking for help and advicefrom a doctor, nurse of pharmacist.

• Adults aged 18 years and over shouldnot use for longer than 9 monthswithout asking for help and advicefrom a doctor, nurse of pharmacist.

Number of Cigarettesyou smoke per day Dose of Gums

20 cigarettesor fewer

One 2 mg gumas required torelieve cravings.

More than20 cigarettes

One 4 mg gumas required torelieve cravings.

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The Nicorette ChewingTechnique

1 Chew slowly until taste becomesstrong.

2 Rest between gum and cheek.3 Chew again when the taste has

faded.nKeep chewing like this for about

half an hour. After this time thegum will have lost its strengthand you should dispose of itcarefully.

How to stop smoking:your choice Because smoking is an addiction,you may find it difficult to giveup. From time to time you maystill have strong urges to smokebut if you follow theserecommendations, you have agood chance of quitting.Some people may find it easier toset a quit date and stop smokingimmediately.

How to chew NicoretteGum – the NicoretteChewing TechniqueThe method of chewingNicorette Gum is not the same asfor ordinary chewing gum.Nicorette Gum is chewed torelease nicotine then rested sothat nicotine can be taken inthrough the lining of the mouth.If Nicorette Gum is chewedcontinuously, the nicotine isreleased too quickly and isswallowed. This may irritate yourthroat, upset your stomach orgive you hiccups.If you have false teeth you mayhave difficulty chewing the gumas Nicorette Gum could stick tothem and on rare occasions,damage dentures. If youexperience a problem, othertypes of nicotine replacementtherapy such as a skin patch,inhalator or microtab may bemore suitable for you.

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you are using, talk to your doctor,nurse or pharmacist. RememberNicorette Gums are not intendedas a substitute for smoking, theyare an aid to give up.Use one of the two optionswhich follow.

Stopping ImmediatelyThe idea is to stop smokingimmediately and use the gum torelieve the cravings to smoke.After achieving this you thenstop using the gums.There is a difference in how youstop depending on whether youare aged 12 – 18 years or are 18 years or over. Make sure thatyou follow the instructions forthe age range applicable for you.

Adults aged 18 yearsand overSee the following diagram whichshows the basic step by stepprocess. The times given below

Others who are unable or notready to stop smoking abruptly,may benefit from graduallyreducing the number ofcigarettes they smoke each dayuntil they feel able to stopcompletely. If you are an adult you canfollow either one of theseoptions. However childrenshould follow the guide tostopping immediately as therecommended duration ofnicotine replacement therapy inchildren is 12 weeks maximum.The only time children shouldstop gradually is if they arehaving a problem stoppingimmediately and they should talkto their doctor, nurse orpharmacist beforehand.If you find it hard to stopsmoking using Nicorette Gums,you are worried that you willstart smoking again without gumor you find it difficult to reducethe number of Nicorette Gums

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are the longest amount of timethey should take, and you shouldtry to achieve your move to thenext step in the shortest timepossible.Make sure that you read theinstructions for each step in theinformation which follows.

Step 1: Set a date to quit andstop smoking cigarettes.

Step 2: Use the gum for up to 12 weeks (3 months) torelieve your cravings tosmoke. See the dosingtable in “When to useNicorette Gum” on page13 to decide whichstrength of gum to use andhow often you can take it.

Step 3: Start to reduce thenumber of gums youuse. You should try to

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use fewer pieces of gumeach day. When you areusing only one or twopieces per day, youshould stop completely.

äIf you need to use the productfor longer than 9 months, askyour doctor, nurse or pharmacistfor advice.

äThe use of 2 mg gums may behelpful when withdrawing fromtreatment.

äYou might feel a sudden cravingto smoke long after you havegiven up smoking and stoppedusing Nicorette Gum. Rememberyou can use nicotine replacementtherapy again if this shouldhappen.

Children aged 12 yearsand overSee the following diagram whichshows the basic step by step

Preparation

Step 1

12 weeks

(3 months)

Step 2

Gradually

reduce usage

Step 3

Time for

each step

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process. The times given beloware the longest amount of timethey should take, and you shouldtry to achieve your move to thenext step in the shortest timepossible.Make sure that you read theinstructions for each step in theinformation which follows.

Step 1: Set a date to quit andstop smoking cigarettes.

Step 2: Use the gum for 8 weeks(2 months) to relieveyour cravings to smoke.See the dosing table in“When to use NicoretteGum” on page 13 todecide which strength ofgum to use and howoften you can take it.

Step 3: Reduce the number ofgums you use over a

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period of 4 weeks. Youshould try to use fewerpieces of gum each day.When you are using onlyone or two pieces per day,you should stop completely.

äThe use of 2 mg gums may behelpful when withdrawing fromtreatment.

äDo not use for longer than 12weeks in total without askingfor help and advice from yourdoctor, nurse or pharmacist.

Stopping GraduallyThe idea is to start by graduallyreplacing some of your cigaretteswith the gum. After achieving thisyou then give up cigarettescompletely while using the gum.Finally, you give up using the gum.There is a difference in how youstop depending on whether youare aged 12 – 18 years or are 18years or over. Make sure that youfollow the instructions for the agerange applicable for you.

Preparation

Step 1

8 weeks

(2 months)

Step 2

4 weeks

(1 months)

Step 3

Time for

each step

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feel the urge to smoke,until you feel ready tostop completely. See thedosing table in “When touse Nicorette Gum” onpage 13 to decide whichstrength of gum to useand how often you cantake it.äIf after 6 weeks you

have not reduced thenumber of cigarettesyou smoke, ask yourdoctor, nurse orpharmacist for advice.

äYou should aim to stopsmoking completely bysix months from thebeginning of treatment.

Step 3: Stop smoking. Cut out allcigarettes and continueusing the gum for up to3 months to relieve yourcravings to smoke.

Step 4: Start reducing the use ofthe gum. You should tryto use fewer pieces of

Adults aged 18 yearsand overSee the following diagram whichshows the basic step by stepprocess. The times given for steps2 and 3 are the longest theyshould take, and you should tryto achieve your move to the nextstep in the shortest time possible.Make sure that you read theinstructions for each step in theinformation which follows.

Step 1: Work out how manycigarettes you smoke perday. Set a date to startreducing the number ofcigarettes you smoke.

Step 2: Start reducing. Over thenext few months, reducethe number of cigarettesyou smoke by usingNicorette Gum when you

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24 weeks (6 months)

Step 2

Preparation

Step 1

Timefor eachstep

12 weeks (3 months)

Step 3

Graduallyreduce usage

Step 4

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If you have used toomany gums If you have used more than therecommended dosage you mayexperience nausea (feeling sick),salivation, pain in yourabdomen, diarrhoea, sweating,headache, dizziness, hearingdisturbance or weakness.

ä If you do get any of theseeffects contact a doctor or yournearest hospital Accident andEmergency departmentimmediately. Take this leafletand the pack with you.

If a child has used orswallowed the gums

ä Contact a doctor or your nearesthospital Accident and Emergencydepartment immediately if a childunder 12 years uses, chews orswallows this medicine. Take thisleaflet and the pack with you.Nicotine ingestion by a child mayresult in severe poisoning.

gum each day. When youare using only one ortwo pieces per day, youshould stop completely.

ä The use of 2 mg gums may behelpful when withdrawing fromtreatment.

ä If you need to use the productfor longer than 9 months, askyour doctor, nurse or pharmacistfor advice.

Children aged 12 yearsand overChildren should follow the guideto stopping immediately. Therecommended duration ofnicotine replacement therapy inchildren is 12 weeks maximum.The only time children shouldstop gradually is if they arehaving a problem stoppingimmediately.Talk to your doctor, nurse orpharmacist before attempting tostop gradually.

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n restlessnessn poor concentrationn increased appetite or weight

gainn urges to smoke (craving)n night time awakening or sleep

disturbancen lowering of heart rate

Effects of too much nicotineYou may also get these effects ifyou are not used to inhalingtobacco smoke.These effects include:n feeling faintn feeling sick (nausea)n headachen hiccupping (due to excessive

swallowing of nicotine)

Side-effects of Nicorette GumNicorette Gum can sometimescause a slight irritation of thethroat at the start of thetreatment. It may also causeincreased salivation.

4 Possible side-effectsLike all medicines, Nicorette Gumcan have side effects. As many ofthe effects are due to nicotine,they can also occur whennicotine is obtained by smoking.

Effects related to stopping smoking (nicotine withdrawal)

You may experience unwantedeffects because by stoppingsmoking you have reduced theamount of nicotine you aretaking. You may also experiencethese effects if you under useNicorette Gum before you areready to reduce your nicotineintake.These effects include:n irritability or aggressionn feeling lown anxiety

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Uncommon side-effects:(less than 1 in every 100 peopleare affected)n hives (urticaria)n redness or itching of the skinn chest palpitations

Rare side-effects:(less than 1 in every 1,000 peopleare affected)n allergic reactions (swelling of

the mouth, lips, throat andtongue, itching of the skin,swelling of skin, ulcerationand inflammation of the liningof the mouth).

Very rare side-effects:(less than 1 in 10,000 people areaffected)n abnormal beating of the heart

ä If you notice these or any otherunwanted effects not listed inthis leaflet tell your doctor,nurse or pharmacist.

Those who suffer from indigestionmay suffer from heartburn orindigestion and may benefit fromslower chewing and use of the 2 mg gum.The gum may occasionally stick todentures and in rare casesdamage them.

Very common side-effects:(more than 1 in every 10 peopleare affected)n headachen sore mouth or throatn jaw-muscle achen stomach discomfortn feeling sick (nausea)n hiccups

Common side-effects:(less than 1 in every 10 peopleare affected)n dizzinessn sickness (vomiting)

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6 Further information

What’s in this medicine?The active ingredient is: 4 mgNicotine.Other ingredients in Nicorette 4 mg Gum are: Chewing gumbase, sorbitol, sodium carbonate,flavourings, polacrilin, glycerol,quinoline yellow (E104) (yellowcolour) and talc. The chewinggum base contains butylatedhydroxy toluene (E321), an anti-oxidant.Other ingredients in NicoretteMint 4 mg Gum are: Chewinggum base, xylitol, sodiumcarbonate, peppermint oil,menthol, polacrilin, magnesiumoxide, quinoline yellow (E104)(yellow colour) and talc. Thechewing gum base containsbutylated hydroxyl toluene(E321), an anti-oxidant.

ä When you stop smoking you mayalso develop mouth ulcers. Thereason why this happens isunknown.

5 Storing anddisposaln Keep Nicorette Gum out of

reach and sight of children andanimals. Nicotine in high dosescan be very dangerous andsometimes fatal if taken by smallchildren.

n Do not store Nicorette Gumabove 25°C.

n Do not use the gum after the‘Use before’ date on the box orblister strip.

n Dispose of Nicorette Gumsensibly away from children andanimals.

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Who makes Nicorette Gum?The Product Licence holder isMcNeil Products Ltd, Maidenhead,Berkshire, SL6 3UG, UK.The manufacturer is McNeil AB,Helsingborg, Sweden.

This leaflet was revised in January 2008. ©

7 Helpful tips on giving upYou may have tried to stopsmoking before and you knowfrom bitter experience that it’snot easy to give up cigarettes.However, you have now taken thefirst constructive step towardsbecoming a non-smoker. Inovercoming your tobaccodependence you will have totackle two problems:1 Your smoking habit.2 Your addiction to nicotine.

Other ingredients in NicoretteFreshmint 4 mg Gum are:Chewing gum base, xylitol,acesulfame potassium, sodiumcarbonate, peppermint oil,menthol, polacrilin, magnesiumoxide, quinoline yellow (E104)(yellow colour), titanium dioxideE171 (white colour), talc, acaciaand carnauba wax. The chewinggum base contains butylatedhydroxyl toluene (E321), an anti-oxidant.None of the gums contain sugar(sucrose) or animal products.

What the medicine looks likeThe gums are blister packed insheets of 6, 10 or 15 andsupplied in packs of 10 or 12pieces (Freshmint), 15, 30 or 105pieces (Original, Mint andFreshmint) or 210 pieces(Original and Freshmint). Not allpack sizes may be marketed.

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2 Break your routineFor a number of years you willhave become accustomed tosmoking at certain times, withparticular people or in certainsituations. Think about the timesyou will miss smoking the mostand plan how you will cope onthese occasions. Changing yourroutine will help you break thehabit of smoking.

3 Quit with a friendQuitting with a fellow smoker is agood idea. It will strengthen yourresolve and build on yourdetermination.Encourage a friend or familymember to quit with you. It willgive your morale a boost sincethere will be another personknowing exactly what you’refeeling and with whom you canshare your resolve to quitsmoking.

4 Remove any temptation35

WillpowerThe overriding success factor inquitting is how determined youare. The first few weeks ofquitting or reducing the numberof cigarettes you smoke willprobably be the most difficultbecause your smoking ritual is stillfresh in your mind.However, you will find that as timegoes by, your willpower becomesstronger. Telling friends, family andwork colleagues that you have quitsmoking and that you envisage atough time ahead will encouragethem to support you.

1 Pick the right dayThere is never a perfect time togive up smoking, but you shouldplan ahead by choosing a date inthe not too distant future onwhich you are going to give upcigarettes completely, or startreducing the number of cigarettesyou smoke. Try to pick a daywhen you will not be too stressed.

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6 Distract yourselfWhenever you feel the urge tosmoke coming on, distractyourself by keeping active. Don’tfeel sorry for yourself. Get up anddo something. Do that job aroundthe house or garden that you’vebeen putting off or take up ahobby.Remember that the craving onlylasts a few minutes.

7 Learn to relaxOnce you have stopped smoking,taking exercise regularly will notonly help you get fitter but willencourage you to relax. Exercisehas the ability to relieve stress andtension. Taken regularly it willbenefit you physically andpsychologically.If you haven’t exercised for sometime, take it slowly to begin withand increase the amount of timespent exercising over the course ofa few weeks. Not only will

To help yourself succeed be sure toremove all cigarettes, matches,lighters etc. from your home, carand work. Ask your friends andcolleagues not to offer youcigarettes or smoke close by youbut be careful not to offend them.Explain that you have given up.This type of support from friendsis of greatest benefit for the firstcouple of weeks of quitting, asthis is your most vulnerable time.The last thing you want is acigarette close at hand in amoment of weakness.

5 Take one day at a timeWhen you reach your Quit Day,don’t allow yourself to think thatyou’re quitting for good. That willmake it seem like a superhumantask. Just promise yourself “Iwon’t have a cigarette today” andtake it one day at a time. You’llbe surprised how much that littlethought helps.

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your only option is to go back tosmoking. Don’t think of it ashaving failed, just think throughthe reasons why you wanted toquit in the first place and don’tlet those couple of cigarettes getthe better of you. Refer back toyour plan and start again. Youcan beat it!

10 If you don’t succeedGiving up is more difficult forsome people than others.If you fail to stop first time,don’t be disheartened. Try againat a later date – you can do it!Remember the most successfullong term ex-smokers haveusually had to try several timesto stop smoking – if you don’tsucceed – quit quit again.

For further informationRead about Nicorette ActiveStopon the next few pages. This is apersonalised support programmewhich works with Nicorette to

exercising help you relax but it alsohelps to keep your weight undercontrol, which some people find aproblem when quitting.

8 Think cash not ashOne of the really noticeablebenefits of ‘stopping’ is the extracash that’s suddenly available. To emphasise the point put themoney into a pot marked ‘cashnot ash’ and watch it accumulate.But be sure to use the money totreat yourself. You deserve areward for not smoking.

9 Dealing with relapsesYou might find that in times ofstress, reaching for a cigarette isthe only thing that will help youthrough. There may also becertain situations – particularlysocial situations such as a partyor in the pub – wheretemptation just gets the betterof you, so you smoke one or twocigarettes. You might feel that

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How can ActiveStop help me?

ä Nicorette ActiveStop is an advanced,interactive online programme withmobile phone support. It has beendevised by experts and is based onproven scientific principles, to helpyou give up smoking for good.

ä It has been specially designed to beused alongside Nicorette and is onhand 24 hours a day through theinternet and your mobile phone.

ä Nicorette works with your body tohelp you deal with the physicalcraving for nicotine, whilstActiveStop gives you practical dailysupport coaching you all the wayuntil you've stopped smoking.

Call now on 0800 244 838.

support you, with the aim ofhelping you give up smoking.All you need is internet accessand a mobile telephone.

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Personalised support programme

Enrol on the internet or callnow on 0800 244 838.

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What will I get?On your personalised ActiveStop webpages you’ll have access to:

DiaryThrough a series of daily tasks, we’llguide you through managing yourthoughts, feelings and behaviour andhow you can plan each day so thatyou are ready to face whatever arises.

Progress MonitorThe Progress Monitor brings togetherall of the headway you are making inone easy-to-view place. From howmuch money you’re saving, to healthfacts and fitness levels, it will keep youmotivated throughout the programme.

Today’s ArticlesDaily articles cover a range of topicsfrom the changes your body is under-going to tips to cope with theinevitable cravings.

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And the Craving Help-LineIf ever you feel the urge to smoke youcan call anytime day or night and byselecting the kind of problem you areexperiencing, you’ll be able to listen torelevant, on-the-spot advice.

Call now on 0800 244 838.

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