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Information for the user

NicAssist Ice Mint Gum (Nicotine)

This medicine is available without prescription to help relieve and/or prevent unpleasant withdawal 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 use 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). ft 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 cravings for nicotine that you get:

When you stop smoking completely

When you cut down on the number ot cigarettes you smoke whie you

try to give up

If you reel unable to stop smoking but you don't want to 3moke cigarettes or you want to avoid causing harm to others, such as when you are with -friends or family, or

If 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 pane or train etc.

This medicine can also be used when you are pregnant or breastfeeding to help you stop smoking, as the risk to your baby when using this product is far less than if you continue to smoke. For more rrfarmation see "Other important information".

When you stop smoking, cut down, or you can't or don ft want to smoke, your body misses the nicotine mat you have been getting from the smoke. 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

Kent your craving to smoke but will not give you the "buzz" you get 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

Fortbe best effect, ensure that you use Boots NicAssist Ice Mint Gum correctty-sae “Howto 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 cause smoking related disease and death, not the nicotine.

You mHy think that smoking helps 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 ot relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning

Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as krttabitty, 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 gain that may be experienced when tryng to stop smoking Use of NRT 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 la In this medlckw*)

• If you are a child under 12 years of ege

l Talk to your pharmacist, nurse or doctor

» If you are In hospital because of heart disease (e.g. heart attack, problems wtth you heart rate or rhythm, stroke, angina or high blood pressure) - try to give up smoking first without using NFTT. 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

•    If you have diabetes - monitor your blood sugar levels more often when you start using this medicine. You may find that you need to adjust the amount of hsulln that you use, or the amount of tablets that you take (ask your doctor or cf abetes nurse about this)

•    If you have an ulcer in your stomach or upper intestine or problems such as pain or swelling of the stomach or oesophagus (the passage between yoir mouth and stomach)

•    If yoir liver or kidneys do not work property

•    If you havB an overactive thyroid gland

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

•    If you are taking other medicines regularly prescribed by your doctor (see “If you take other medicines”}

•    If you are pregnant or breastfeeding (see “Other Important information”)

Other important information

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

However, if you still need he£ to stop smoking, you can use this product as the risk to your baby is far less than if you continue to smoke. You should talk to your pharmacist, nuse or doctor for more advice.

NRT predicts that are used Irrtermttterrtty, 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 tor 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 NFTT,

Breastfeeding your baby Just before you use the gum make you baby g^s the smallest amount of nicotine possible.

The amoint 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 smote they would Inhale If you smoked. Tobacco smoke causes breathing and other health problems In babies and chlcfren. If your husband, partner or other family members smoke too, tjytogetthemtogivBup with you,

Nicotine products and chlkken: Nicotine can be very dangerous to chiden. The amount of nicotine tolerated by adults and adolescents can make children very III, and can sometimes be fatal. Do not leave you gum where children may get hold of It.

B The chewing gum ----_t ^

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, particiJarly the fallowing:

•    Theophylline, clozapine, rapinirole - 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

Read 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 make sure that you chew the gum correctly to ensure that nkxrthe is released and passes into you body through the lin'ng of your mouth

The strength and rximber of guns you use each day wll depend on how many cigarettes you smoke 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 wil also be useful for heavier smokers as they gradually start to reduce the strength and number of guns they use each dee/.

651371

Boots hfcAssst Ice MrfSjti srioukTbeUsecl wtienevar the"ufge fbsmbke ” ' is felt or when you wtxid normally expect to have cravrgs to smoke It is recommended that to successfully reduce the amount of cigarettes you smote 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 are ready to stop smoking completely, you should use the gums, when needed, to replace all 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 atop smoking complatoly, you should

replace as marry agarettes as possible with the gums. Boots NicAssist Ice Mint Gum provides a safer alternative to smoking tor you and those around you, as it is the toxins in cigarette smoke that cause harm, not the nicotine. Reducing the amount of cigarettes you smoke may also help you to become more motivated 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, or for whenyrou 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.

Adults and children of 12 years and over

You should always aim to stop smokrtg completely whist using the gums.

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

How to use the gum

The method of chewing Book NicAssist Ice Mint Gum is not the same as for ordinary chewing gum. If the gum Is chewed all the time (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.

If you have Mse teeth you may have difficulty chewing the gun as it may stickto them, and on rare occasions, damage dentures. If ycu experience a problem, other types of rTcotine replacement therapy such as a skin patch, ilhalalor, lozenge or mlcrotab maybe more siJtable for you.

Chewing technique

1    Chew sbvwy 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

t If you me too many gums: You may get the folbwlrg symptoms -feeling sick, salivation, pain In your stomach, dlarriioea, sweating, headache, dizziness, hearing disturbance, weakness. If this happens stop 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

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 nodes any of ths following sari dub aids affects, stop using the medicine, do not smoke and see your doctor as soon as posskNe: You develop a fast, slow or irregular heart beat You have an allergic reaction to the gum such as rash, Itching or swelling offrnetongje, mexith or throat (go strait to casualty If severe)

Effects related to stopping smoking (nicotine withdrawal)

You may experience unwanted effects because by stopphg smoking or using the guns when you are unable to smote 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:

Irritabiity or aggression, feeling low, anxiety, restlessness

Poor concentration, urges to smote (craving), night time awakening or

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 feint, feeling sick (nausea), headache

Hiccupping (due to swallowing too much nicotine when you chew)

(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, dianhoea, 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 cfreams

•    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, hoarseness of the voice

•    Nasal 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

(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:

(less than 1 in 10,000 people are affected)

•    Abnormal 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 the skin

_______you stop smokir.„,______„____

reason why this happens is unkrown.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this leaflet. You ct also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.ukfvellowcard. By reporting side effects you can help provide more Information on the safety of mis medicine.

_____________________j, preferably In a locked cupboard. Nicotine In

high 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 foil or the end flap of the carton. After mis date return any mused predict 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 chwving gum in blister strtos of 1 S's. Each gum contahs rlcotine 2 mg or nicotine 4 mg, i which Is the active Ingedent.

As well as the active in^Bdient, the ^im also contains chewing gum base (containing butylated hydraxytduene E321), xylitol, peppermint oil,' sodkim carbonate, acesutfame potasskim, levomenthol, magnesium oxide, talc, flavou (wlnterfresh), hypromellose, sucralose, porysorbate 80, purified water, starch, titanium dioxide (B171), camauba wax.

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

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

Who makes this medicine

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

Leaflet prepared December 2015

If you would like arty further information about this 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)

Rease be ready to give the following information:

Product name    Reference Number

Boots NicAssist Ice Mint 2 mg Gum    15513/0152

Boots NicAssist Ice Mrrt 4 mg Gum    15513/0153

This is a service provided by the Royal National Institute of Bird People.'

Reference: BTC 148453 Action: F

Date 16 Dec 2015