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Information for the user

NicAssist Minty Fresh Gum (Nicotine)

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

What this medicine is for

This medicine contains nicotine which belongs to a group of medicines called nicotine replacement therapy (NRT). tt 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 U3ed to relieve the symptoms of nicotine withdrawal and to relieve and/or prevent the craJngs for nicotine that you get:

When you stop smoking completely

When you cut down on the number of cigarettes you smote whie you try to give up

If you reel unableto stop smoking but you don't want to smoke cigarettes or you want to avoid causing harm to others, such as when you are with friends or family, or

tf you feel unable to stop smoking completely but you can't smoke cigarettes, such as when you are at a party, in the pub, at work, on a plane or train etc.

This medicine can also be used when you are pregnant or breastfeeding to help you stop smoMng, a3 the risk to your baby when using this product Is far less than If you continue to smoke. For more information see "Other Important Information".

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

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 smoMng 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 Minty Fresh Gum correctly - see "How to use the gum".

The 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 related disease and death, not the nicotine.

You may think that smoking help3 relieve feelings of anxiety and stress, but It does not deal with the cause of the stress and leads to a number of serious diseases. In addition, the feeling of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning

Nicotine replacement theracw can help relieve nicotine withdrawal symptoms such as hrttabitty, low mood, anxiety, restlessness and cravings when used In place of cigarettes.

NRT may benefit smokers who want to quit, by helping to control weight gaki that may be experienced when trying to stop smoking Use of NFfT is safer than smoking tobacco but as soon as you are ready, you should aim to stop smoking completely.

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 shoiJd seek the advice of their pharmacist or doctor first,

X 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, problems wtth yoir heart rate or rhythm, stroke, angina or high blood 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

adjust the amount of insulin that you use, or the amount of tablets tt you take (ask your doctor or dabetes nurse about this)

•    If you have an ulcer In your stomach or upper Intestine or problems such as pari or swelling of the stomach or oesophagus (the passag between you mouth and stomach)

•    If you liver or kidneys do not work properly

•    If you have an overactive thyroid gland

•    If you have high blood pressue due to a tumour near you kidney (your doctor may have told you that you have a condition called

p h aeoc h ro m ocyto m a)

•    If you are taking other medicines regularty prescribed by your doctor (see "If you take other medicines")

•    If you arepregnant or breastfeeding (see “Other Important Information")

Other important information

jTjjjOu are pregnant You should try to stop smoking without using

However, If you still need hereto stop smoking, you can use this procfoct as the risk to your baby Is tar less than ft you continue to smoke. You should talk to your pharmacist, nuse or doctor far more

NFIT products that are used intermittentty, 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 tney should be taken off before bedtime.

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

However, if you still need he£ to stop smoking, it is recommended that you use NFfT products that are used intermittently, not patches. ” should tak to your pha/maciat, nurse or doctor for more advice, jr baby Just before you use the gum ms ie smallest amount of nicotine possible.

The emouit of nicotine that your baby may receive when you are using the gum or other NRT products is much smaller and less harmful than the second-hand smoke they would inhale if you smeked. Tobacco smoke causes breathing and other health problems in babies and chlcfren. If your husband, partner or other famlty membera smoke too, try to get them to give up wtth you.

Nicotine products and chlkben: Nicotine can be very dangerous to chicken. The amount of nicotine tolerated by adutts and adolescents can mate children very ill, and can sometimes be fatal. Do not leave you gum where children may get hold of it.

the ingredients can cause problems: The chewing gum Bins butytated hydroxytoiuene (E321), an antFoxldant. May cause weal skin reactions (e.g. contact dermatitis) or Irritation to the eyes and mucous membranes.

If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, partlcUariy 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 smoking 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

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

•    Follow the instructions in 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 mate sure that you cheW

the gum correctly to ensure that nkjothe Is"'¹-----'    ^-.....'-*■

you body through the lining of your mouth The strength and number of guns you use each day wil depend on how many cigarettes you smote and how strong they are.

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

•    The 4 mg gum should be used for those who smote more than 20 cigarettes a day

However, the 2 mg gum wll also be useful for heavier smokers as they gradually start to reduce the strength and number of guns they use each day.

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•    Boots NhAssht Minty Fresh GurT sfriicfEx) ilsbd whenever the urgelo smoke is felt or when you would normaly expect to have cravings to smote

•    It is recommended that to successfully reduce the amount ot cigarettes you smote or stop smoking complete 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 are ready to atop smoking complataly, you should use the gums, when needed, to replace ail of your cigarettes. As soon as you feel ready (this could be alter 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 stop smoking complatsty, you should replace as many cigarettes as possible with the gums. Boots NicAssist Minty Fresh Gum provides a safer alternative to smoking tor you and those arouid you, as it is the toxins in cigarette smote mat cause harm, not the nicotine. Redudrg the amount of cigarettes you smote may also help you to become more motivated to stop smoking. As soon as you feel reedy, you should aim to stop smoking completely

•    You can also use Hie guma when you cant 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 ortraln 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

.................hearttxjm, dianhoea, wind

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

•    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)

■    Hushing, high blood pressure

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

'-------na of the voice

Reference: BTC148455 Action: E

Date: 15 Dec 2015

Adults and children of 12 years and over

al congestion, sneezing

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

■    Itching, skin rash, hives, excess sweating

•    Jaw pain

•    Generally feeling unwell or weak, chest pains

You should always airi to stop smoking 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 Minty Fresh Gum is not the same as for ordinary chewing gum. tf the gum Is chewed all the time (continuously), the nicotine Is released too qdckly 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 fdse teeth you may have difficulty chewing the gun as it may to them, and on rare occasions, damage dentures. If ycu experience a problem, other types of rtcotine replacement therapy such as a skin patch, hhalator, lozenge or mlorotab m^be more siJtable far you.

Chewing technique

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

f If you me too many guma: You may get the folbwlrg symptoms -feeling sick, salivation, pain In your stomach, dlanhoea, sweating, headache, dizziness, hearing disturbance, weakness. If this happens •top 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. Tate 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 sometimes 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 the following sari dub aids affects, stop using the medicine, do not smoke and see your doctor as soon as posskrie:

• You develop a fast, slow or irregular heart beat • You have an allergic reaction to the gum such as rash, Itching or swallhg Of ihetongje, 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 nicotine you are getting. You may also experience these effects If you use too few guns before you are ready to reduce your nicotine Intake. These effects include:

• Initabiity or aggression, feeling low, anxiety, restlessness • Poor concentration, urges to smote (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 smote, You may be able to relieve these effects by using the gums less often,

These effecto include:

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

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

•    Swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of the skin, ulceration and swelling of the lining of the mouth (allergic reactions)

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

....."-in 1 in 10,000 p..^____

al beating of the heart ts wtth an urknown frequency:

■    Severe allergc reaction

•    Blurred vision, watery eyes

■    Dry throat, stomach discomfort, lip pain

- --'—-bs of the Jaw

ss of the skin

Reporting of side effects    j ■

If you get any side effecte, talk to your doctor, pharmacist or nurse. i Z This includes any possible side effects not listed on this leaflet. You cam Z o report side effects directly via the Yellow Card Scheme at:    ¹ ■

wcard. By reporting side effects you can help ] ■ m on the safety of mis medicine.

How to store and dispose of this medidnd

Do not store above 25°C.

Keep this medicine In a safe place out of the sight and reach of chlkken and anfenala, preferably In a looted cupboard. Nicotine In hi^i amounts can be very dangerous and sometimes fetal if used or swallowed by small children,

Store the gum In the original pack,

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

What is in this medicine

This pack contains 30,105 or 210 pieces of medicated chewing gum In blister strips of 1 Sfe. EachgumcorrtaJnsnlcotlne2mgornlcotlne 4 mg, which is the active ingredent.

As well as the active ingedient, the gjm also contains chewing gum i base (containing butytated hydroxytoluene E321), xylltol, peppermint oil, sodium carbonate, polacrilh, acacia, titanium dioxide (E171), acesulfame potassium, menthol, camauba wax, magnesiun oxide, talc.

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

None of the gums contain sugar (sucrose) or animal prodjets.

Who makes this medicine

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

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

Leaflet prepared December 2015

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

Other formats

To reediest a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following Information:

Product name    Reference Number '

Boots NicAssist Minty Fresh 2 mg Gum    15513/0173

Book NicAssist Minty Fresh 4 mg Gum 15513/0174 This is a service provided by the Royal National Institute of Blind People-!