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Nicorette Fruitfusion 4mg Gum

Document: leaflet BOOTS_PL 15513-0137 change

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Information for the user


NicAssist Fruit Fresh Gum (Nicotine)


Read Hi of this leaflet carefully because It contakis Important Information for you.

This medicine is availabie without prescription to help relieve and/or prevent unpleasant withcfrawal symptoms and cravings for nicotine when you are trying to give up smoking or for when you can't or don't wart to smoke cigarettes. However, you need to U3e It carefully to get the best results from It

Keep this leaflet, you may need to read It again

Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains nicotine which belongs to a group of medicines called nicotine replacement therapy (NRT). it acts to substitute the nicotine that you normally get from cigarettes and can be used to relieve and/or prevent unpleasant withdrawal symptoms and cravings for nicotine when you are stopping smoking, cutting down or for when you can't or don't want to smoke cigarettes, it can be used to relieve the symptoms of nicotine withdrawal and to relieve and/or prevent the cra/ngs for nicotine that you get:

When you Stop smoking completely

When you cut down on the number of cigarettes you smote whie you


st the amount of fisulin that you u:


sr the amount of ta


such as pah or swelling of the stomach or oesophajjs ftt between you mouth and stomach)

• If yoir liver or kidneys do not work property


doctor may havB told you that you have a condition called phaeochromocytoma)

• If you are taking other medicines ragularty prescribed by your doctor

-----'you take c-------------


(see “If you fa

• If you are pregnant o Informenorr)


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•    Boots NcAssst Fru rtTrBsffGIxh sfou U Seljsed whenever tfie-Jge to smoke is felt or when you would normaly expect to have cravings to smote

•    It is recommended that to successfully reduce the amount of cigarettes you smoke or stop smoking completely you shoiid use the gums as often as possible and It Is up to you how many gjms you use (up to 15 a day) and for how long

•    If you ara ready to atop amoldng completely, you should use the gums, when needed, to replace ail of your cigarettes. As soon as you feel ready (this could be after a number of weeks or months) you shoiid reduce the strength, If required, and number of gums used per day until you no longer need to use the guns

•    If you are not ready to slop smoking completely, you should replace as marry cigarettes as possible with the gums. Boots NicAssist Fruit Fresh Gum provides a safer alternative to smoking tor you and those around you, as it is the toxins in cigarette smote that cause harm, not the nicotine. Redudrg the amount of cigarettes you smoke may also help you to become more mottvaled to stop smoking. As soon as you feel ready, you should aim to stop smoking completely

•    You can also use the gums when you can't or don't want to •moke, such as social occasions e.g. at a party, in the pub, orfor when you are at work, or on a plane or train etc.

When making an attempt to stop smoking completely behavioural therapy, advice and support will normally improve the success rate.


(more than 1 in • Headache


every 10 people are af


ig sick, hiccups Common side effects:

' ss than 11n every 10 people are affected)

_ s, pins and needles

.................hearttfem, dianrioea, wind

Dry mouth, being sick, Inflammation of the mouth, Increase In saliva

•    Bunlng sensation In the mouth, feeling tired Uncommon side effects:

(less than 1 in every 100 people are affected)

■    Abnormal ckeams

•    Changes In heart rhythm (you may notice a fast heart rate or beat)

■    Rushing, high blood pressure

•    Throat tightness, difficulty in breathing, shortness of breath,

■-------is of the voice


Reference: BTC147784 Action: F

Date: 15 Dec 2015


If you


iu reel unable to stop smoking but you don't want to smoke irettes or you want to avoid causing harm to others, such ai are with friends or family, or


unable to stop smoking completely but you can't smoki _    , such as when you are at a party, in the pub, at work, a

plane or train etc.

This medicine can also be used when you are pregnant or breastfeeding to help you slop smoking, as the risk to you


Other important information

If you are pratyrant You should try to stop smoking without using NRT.

However, if you still need hefctostop smoking, you can use this proofed as the riskto your baby is far less than if you continue to smoke. You should talk to your pharmacist, nirse or doctor for more advice.

NRT products that are used Intermittently, such as this one, may be preferable to nicotine patches. However, if you feel sick or are sick (morning sickness) the patches may be better for you. If you do use nicotine patches they should be taken off before bedtime.

If you are breastfeeding: You should try to stop smoking without using NRT.


Adults and children of 12 years and over

20 cigarettes or fewer

One 2 mg gian as required to relieve and/or prevent cravligs

More than 20 cigarettes

One 4 mg gian as required to relieve and/or prevent cravligs

Use only one piece of gum at a time. Don't use more than 15 gums per day.

(less than 1 in every 1,000 people are affected)

• Swelling of the mourn, lips, throat and tongue, itching of the skin, swelling of the skin, ulceration and swelling of the lining of'" “ reacts)


al congestion, sneezing

■    Belching, Inflammation of me tongue, mouth ulcers, tingling mouth

■    Itching, skin rash, hives, excess sweating

•    Jaw pain

•    Generally feeling unwell or weak, chest pairs


Whan you stop smoking, cut down, or you can't or don't want smoke, your body misses the nicotine that you have been gettii _ the smote. You may experience unpleasant feelings and a strong desire to smoke ("craving").

This shows that you are dependent on nicotine. When you use the gum, nicotine Is released and passes Into your body through the lining of you- mouth. The nicotine Is sufficient to relieve and/or prevent the unpleasant withdrawal symptoms. It will also help to relieve and/or prevent your craving to smote but will not give you the "buzz" you get from a cigarette.

You should always aim to stop smoking completely whilst using the gum. To help you cut down or stop smoking completely you should also try to use a behavioural support programme to Increase your chances of successfully stopping smoking.

Benefits you can get from using NRT instead of smoking

For the best effect, ensure that you use Boots NicAssist Fruit Fresh Gum correctty - see ‘How to use the gum".

Tha benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smote such as tar, lead, cyanide and ammonia that causa smoking


getting frcm


The amoint of nicotine that your baby may receive when you are using the gum or other NRT products Is much smaller and less harmfljl than the second-hand smoke they would Inhale If you smoked. Tobacco smoke causes breathing and other health problems in babies and chicten. If your husband, partner or other family members smoke too, try to get them to give up with you,


number of serious disea: smoking is temporay, w returning Nicotine replacement therapy ca symptoms such as krtta bitty,

'    ' when used In placeofi



Before you use this medicine

This medicine can be used by adults and children of 12 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

IX Do not use:

•    If you are allergic to any of the ingredients in this medicine (see ■What is in this medicine")

•    If you are a child under 12 years of age

f Talk to your pharmacist, nurse or doctor

•    If you are in hospital because of heart disease (e.g. heart attack,


pressure) - try to give up smoking first without using NRT. However, once you are out of hospital, if you still need help to stop smoking, you can use this medicine. For other heart conditions that do not require you to be in hospital, using NRT is better than continuing to smote


chlden. the amount of nicotine tolerated by adults and t can make children very III. and can sometimes be fatal. Do not leave you gum where children may get hold of it.

lie of the tojpedlanta can causa problems: The chewing gum 3 contains butylated hydroxytoiuene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

If you take other medicines

Before you use this medicine, mate sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Theophylline, clozapine, roplnlrole-your doctor may want to monitor the amount of medicine that you take

When you Stop smoking or reduce the number of cigarettes you smoke, your metabolism slows down. This can mean that some medicines may stay in your body longer than usual, if you take any medicine on a regular basis, tel your doctor that you intend to stop smokirg or reduce the number of cigarettes you smoke and follow his or her advice about these other medicines.

/How and when to use this medicine

Check the foil is not broken before use. if it is, do not use that gum.

When to use the gum

Read all of the following Information carefully before using the gum:

•    Follow the Instructtonsln the table, which shows when you should use the gum and the maximum amount of guns you should be using each day

•    See the "How to use the gum’ instructions to make sure that you chew the gum correctly to ensure that nicotine is released and passes into you- body through the llnltg of your mouth

The strength and number of guns you use each day wil depend on how marry cigarettes you smoke and how strong they are.

•    The 2 mg gum should be used for those who smoke 20 cigarettes or fewer a day

•    The 4 mg gum should be used for those who smoke more than 20


gradually start to reduce the strength and number of gums they use '


You should always aih to stop smokrg completely whist using the gums. If you are unable to reduce the strength or number of gums you are using you should ask for help and advice from a pharmacist, nuse or doctor.

Do not give this medicine to chicken under 12 years of age.

How to use the gum

The method of chewing Book NicAssist Fruit Fresh Gun is not the same as for ordinary chewing gum. if the gum Is chewed all the tine (continuously), the nicotine is released too qhckly and Is swallowed. This may irritate your throat, upset your stomach or give you hiccups. The gum should be chewed and then rested to release the nicotine, which is taken in through the lining of the mouth.

£“ i have false teeth you may have difficulty chewing the gun as it may to them, and on rare occasions, damage dentures. If ytxj experience a problem, other types of Ncotlne replacement therapy such as a skin patch, tihalalor; lozenge or mlcratabm^ be more suitable far you.

Chewing technique

1 Chew stovwy until taste becomes strong 2 Rest the gum between your gums and cheek 3 For about the next half an hour, when the taste fades, chew the gum again. After this time the gun will have lost its strength and you should dispose of It carefully

f If you me too many gums: You may get the folbwlrg symptoms -leelhg sick, salivation, pain In your stomach, dlarriioea, sweathg, headache, dizziness, hearing disturbance, weakness. If this happens atop using the gums and do not smoke. Contact a doctor or hospital casualty department straight away. Take the medicine and this leaflet with you.

If a chid under 12 accidentally uses, swallows, sucks or chews

some of this medicine take them to casualty Immediately. Take the medicine and this leaflet wtth you. Nicotine Ingestion by a child may cause severe poisoning.

Possible side effects

Most people can use this medicine without any problems but sometknes you may notice some side effects. Many of these effects are due to nicotine, they may also happen when you smoke.

If you notice any of ihs following serious aide affects, atop using the medicine, do not smoke and see your doctor as soon as possbia:

• You develop a fast, slow or irregular heart beat • You have an allergic reaction to the gum such as rash, Itching or swslllig Of frietongje, mouth or throat (go strait to casualty If severe)

Effects related to stopping smoking (nicotine withdrawal)

You may experience mwanted effects because by stopphg smoking or using the guns when you are unable to smoke you have reduced the amount of nlcottoe you are getthg. You may also experience these effects If you use too few guns before you are ready to reduce your rlcothe Intake. These effects include:

• Imtabiity or aggression, feeling low, anxiety, restlessness • Poor concentration, urges to smoke (craving), night time awakening or sleep disturbance

• Increased appetite or weight gain • Lowering of heart rate Effects of too much nicotine

You may also get these effects If you are not used to Inhaling tobacco when you smoke, You may be able to relieve these effects by using the gums less often,

These effects include:

• Feeling faint, feeling sick (nausea), headache • Hiccupping (due to swallowing too much nicotine when you chew)


swelling of the skin, ulceration and swelling of the (allergic reactions)

■    Difficulty swalowing, retching, mouth feeling numb \fery rare side effects:

....." to 1 in 10,000 p..,.____

al beating of the heart Side effects wtth an urknown frequency:

■    Severe allergc reaction

•    Blurred vision, watery eyes

•    Dry throat, stomach discomfort, lip pain

•    Tightness of the Jaw

■    Redness of toe skin


Reporting of side effects

Jf you get any side effects, talk to^ur doctor; pharmacist or nurse.


Keep toil medicine in a safe place out of the sight and reach of chlkken and anknals, preferably in a looted cupboard. Nicotine in hl^n amounts can be very dangerous and sometimes fatal If used or swallowed by small children.

Store the gum in the original pack.

Use by the date on the toil or the end flap of the carton. After mis date return any mused proofed to your nearest pharmacy for safe disposal. Dispose of any used gum sensibly.


What is in this medicine

This pack contains 105 pieces of medicated chewing gum in blister strtos of IS^. Each gum contahs Ncotlne 2 mg or nicotine 4 mg, i which Is the active Ing-edent.

As well as the active ingredient, the gjm also contains chewing gum base (containing butylated hydroxytoiuene E321), xylitol, peppermint oil,: sodfem carbonate, acesulfame potassfem, levomenthol, magnesium oxide, talc, flavour (tuttlfrutt), hypromellose, sucralose, potysorbate 80, purified water, acacia, titanium dioxide (E171). camauba wax.

The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also | contains quinoline yellow (E104).

None of the gums contain sugar (sucrose) or animal procfects,

Who makes this medicine

This product is manufactured for The Boots Company PLC Nottingham NG2 3AA by McNeil AB Helsingborg Sweden.

The Marketing Authorisation holder is McNeil Products Ltd Maidenhead Berkshire SL6 3UG.

Leaflet prepared December 2015

If you would like any further information about this product, please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To recuest a copy Of this leaflet In Braille, large print or audio please call, free of charge:

0800188 5000 (UK only)

Pease be ready to give the following information:

Product name    Reference Number

Boots NicAssist Fruit Fresh 2 mg Gum 15513/0136 Boots NicAssist Fruit Fresh 4 mg Gum 15513/0137 This is a service provided by the HoyaJ National Institute of Bird People.'