Nicotinell® Gum Nicotine 2 mg and 4 mg

Consumer Medicine Information

Please read this leaflet before you Firstly there is the psychological Before you use start using this medicine. dependence on cigarettes. The Nicotinell Chewing Gum habit may have become an important part of your life, especially if you have smoked for many years. When you must not use it What is in this leaflet Secondly, there is the physical Do not use Nicotinell Chewing Gum addiction to nicotine to consider. if: This leaflet answers some common Cigarettes contain nicotine and your • Your mouth or throat is sore questions about Nicotinell Chewing body has become dependent on • Gum. nicotine. You are under 12 years old • You are a non-smoker or an It does not contain all the available Nicotinell Chewing Gum works on occasional smoker information. It does not take the reducing your desire to smoke by • place of talking to your pharmacist or providing some of the nicotine that You are allergic or doctor. you previously inhaled from hypersensitive to nicotine or All medicines have risks and cigarettes. This is what helps you to any of the other ingredients in the gums benefits. Your pharmacist or doctor resist smoking. • The expiry date printed on the will be able to advise you about the When chewed, nicotine is released carton or blister platform has risks and benefits of using Nicotinell slowly from the gum and absorbed passed Chewing Gum. through the lining of the mouth. The • The packaging is torn or shows If you have any concerns about amount of nicotine in the gum can signs of tampering using this medicine, ask your also reduce some of the unpleasant pharmacist or doctor. effects that often happen when giving There are no health benefits to up smoking, such as feeling ill or smoking. It is always better to give Keep this leaflet with the medicine. irritable. Nicotinell Chewing Gum up smoking and using Nicotinell can You may need to read it again. does not act as quickly as smoking. help. In general, any possible side effects associated with nicotine Nicotinell Chewing Gum works most replacement therapy (NRT) are far effectively when you have a strong outweighed by the well established personal commitment to stop What is Nicotinell dangers of continuing to smoke. Chewing Gum used for? smoking. You cannot rely on Nicotinell alone to break the habit. If you are in hospital because of a heart attack, severe heart rhythm Nicotinell Chewing Gum can help You are more likely to quit smoking disorders or a stroke, you should try you stop smoking over a few months. when using the product with help to quit smoking without using NRT You can also use it to help you stop from your pharmacist, doctor, a unless your doctor tells you to use it. smoking gradually over a longer trained counsellor or a support Once you are discharged from the period of time, if you cannot stop program. Counselling is available hospital, you may use NRT in smoking immediately. from various groups and to get the best out of Nicotinell, we encourage consultation with your doctor. Whilst giving up isn't going to you to enrol in a supportive group. If you have had allergic reactions that happen immediately, it is a habit you involve swelling of the lips, face and can break. But it's important to throat (angioedema) or itchy skin understand that there are two sides to rash (urticaria), using NRT can quitting smoking. sometimes trigger this type of reaction.

Nicotinell® Published by MIMS/myDr August 2009 1 Before you start to use it Be careful if you have dentures, If you are breast-feeding. dental caps or partial bridges. Nicotine is excreted in breast milk in Talk to your doctor and ask for As with other gums, Nicotinell quantities that may affect the child his/her advice before using Nicotinell Chewing Gum may stick to your even in therapeutic doses. Like Chewing Gum if: dentures, dental caps or partial smoking, nicotine replacement • you have had a recent heart bridges and may damage them. You therapy should be avoided during attack or stroke should stop using the gum if it sticks breast-feeding. However, if you are • you have angina (chest pain) to your dental work and discuss unable to quit without the use of that is not well controlled or is further use with your dentist. nicotine replacement therapy, seek getting worse Driving or operating machinery advice from your pharmacist or • you have severe arrhythmia whilst using Nicotinell Chewing doctor before starting a program. (irregular heartbeat) Gum. You are also recommended to use Nicotinell nicotine chewing gums Talk to your doctor or pharmacist There is no evidence of any risk immediately after breast-feeding, to and ask for his/her advice before associated with driving or operating ensure that the baby gets the smallest using Nicotinell Chewing Gum if: machinery if Nicotinell Chewing Gum is taken according to the amount of nicotine possible. • you have any type of heart recommended dose but remember disease, including angina that smoking cessation can cause • • you have had a stroke at any behavioural changes. time in the past Do not drink coffee or soft drinks How to use Nicotinell • you have high blood pressure for 15 minutes before chewing the Chewing Gum or any circulation disorder gum. • you have kidney or liver They may keep the nicotine in the problems gum from being absorbed properly. How to get started • you have a ulcer or If you are pregnant. Nicotinell Chewing Gum is not like persistent stomach upset Ideally you should not use this ordinary chewing gum. You must • you have hyperthyroidism (a program while you are pregnant, and stop smoking completely while you disorder of the thyroid gland) you should stop smoking without are using it. • you have diabetes, as you using nicotine replacement therapy. It is probably best to nominate a should monitor your blood Nicotine in any form may cause harm specific day that you will stop levels more often than to your unborn baby. However, if smoking. usual when starting Nicotinell you are unable to quit without the use It may be helpful for you to: chewing gum, you may find of nicotine replacement therapy, seek your insulin or other advice from your pharmacist or • Try to choose a day when you medication requirements alter doctor before starting a program. The will not be where others are • you have phaeochromocytoma decision to use NRT should be made smoking. (a tumour of the adrenal gland) as early on in your pregnancy as • Choose a day with as little • you have an inability to tolerate possible and you should aim to use it stress as possible. (as the gums contain for only 2-3 months. Products that • Choose a day not too far in the , which is a source of are taken intermittently, such as gum, future. fructose) are preferable to nicotine patches. Tell your family and friends that you • you are pregnant or However, patches may be preferred if have set this target "quit day". breastfeeding you have nausea or sickness. This is the day you take control of • you are aged 12 to 17 years your habit and become a non-smoker. Tell your doctor or pharmacist if Prepare to stop smoking by trying to you are taking any other reduce the number of cigarettes you medicines, including medicines that you buy without a smoke each day. prescription. Your doctor or pharmacist will be How to use Nicotinell Chewing able to advise you if stopping Gum smoking may affect the way these medicines work. At the beginning of the "quit day", start to use Nicotinell Chewing Gum before any cigarettes have been smoked.

Nicotinell® Published by MIMS/myDr August 2009 2 The appropriate dose will depend on • When you are down to 1-2 2. a. Use Nicotinell Step 2 patch for your previous smoking habits. pieces a day, you can stop using 3-4 weeks, while using the same Nicotinell Gum. number of pieces of Nicotinell Use 2 mg gum if: • You should be able to stop chewing gum 2 mg in a day that • you were smoking less than 20 completely within 6 months you have routinely used. cigarettes a day from the start of the treatment. b. Then use Nicotinell Step 3 for If, while using the 2 mg gum, your a further 3-4 weeks, while using Program B. If you cannot stop withdrawal symptoms remain so the same number of pieces of smoking completely before starting Nicotinell chewing gum 2 mg in a strong as to threaten relapse, then the program: you should use the 4 mg gum. day that you have routinely used. • Gradually increase gum use, c. When patch use is no longer Use 4 mg gum if: while cutting down smoking. needed, gradually reduce the • • you were smoking more than 20 • When you have cut down the number of gums you use until cigarettes a day number of cigarettes you smoke you no longer need them. • you have previously failed to to a level you feel you can quit stop smoking with 2 mg gum completely, follow Program A. Children 12 to 17 years old Chew one piece of gum when you • If you have not cut down the Do not use for longer than 12 weeks. feel the urge to smoke. number of cigarettes you smoke each day after 6 weeks, see you If you think you need to use for Follow these 4 easy steps: doctor or pharmacist. longer than 12 weeks, talk to your 1. Chew one piece of gum slowly doctor or pharmacist. until the taste becomes strong. Combination therapy Chew one piece of gum when you 2. Rest the piece of chewing gum feel the urge to smoke. Follow the If you have relapsed in the past or if between your gum and cheek. directions under 'How to use you experience cravings while using 3. Chew again when the taste has Nicotinell Chewing Gum'. Use every a single form of nicotine replacement faded. 2 to 3 hours. Do not use more than 20 therapy (NRT), you can combine the 4. Repeat the chewing routine for pieces of the 2 mg gum, or 10 pieces use of Nicotinell patch with of the 4 mg gum in one day. about 30 minutes. Nicotinell chewing gum 2 mg. After about 8 weeks, gradually Chew only one piece of gum at a The combination is more effective time. reduce to 1 to 2 pieces a day and then than either product alone in people stop completely. Chew slowly. who have been unable to quit The nicotine in Nicotinell Chewing smoking using a single NRT method, Do not use for children under 12 Gum is released a little at a time and increasing your chances of years. absorbed through the lining of your successfully quitting. mouth into your bloodstream. If you When using Nicotinell Step 1 patch, chew too quickly or for too long, you chew one piece of Nicotinell will swallow the nicotine with your chewing gum 2 mg if you get a While you are using saliva. It will be broken down in your craving. Use at least 4 pieces of gum Nicotinell Chewing Gum stomach and wasted. and not more than 12 pieces in a day. Do not use more than 20 pieces of Continue for 12 weeks. Things you must do the 2 mg gum or 10 pieces of the 4 After 12 weeks, you can wean mg gum in a day.Most people use 8- yourself off therapy by either of the Use Nicotinell Chewing Gum as 12 pieces of the 2mg gum or 4-6 following methods: instructed.If you follow these pieces of the 4mg gum in a day. recommendations you should get the 1. Stop use of Nicotinell patch and full benefit of the Nicotinell gradually reduce the number of Usage Program for adults Program. Nicotinell chewing gum 2 mg you There are two usage programs you use until you no longer need Tell all of the doctors, dentists and can follow: them. pharmacists who are treating you that you are using Nicotinell Chewing Program A. If you would like to stop Gum. smoking completely before starting the program: • After about 3 months, gradually cut down the amount of gum you chew each day.

Nicotinell® Published by MIMS/myDr August 2009 3 Things you must not do Do not be alarmed by this list of After use possible side effects. Do not stop using Nicotinell You may not experience any of them. Chewing Gum suddenly.You may Storage get side effects similar to those you would get if you stopped smoking Keep the gum in the blister pack suddenly. inside the carton until you are If you use too much ready to use it. (overdose) If you take the gum out of its blister pack, it may not keep well. If you smoke or use any other Side effects nicotine containing product while Store the gums in a cool dry place you are using Nicotinell Chewing where the temperature stays below Tell your pharmacist as soon as Gum, you may suffer an overdose of 25°C. possible if you do not feel well while nicotine. However if used correctly, Do not store it or any other you are using Nicotinell Chewing nicotine overdose is unlikely. medicine in the bathroom or near a Gum. The general symptoms of nicotine sink. Nicotine, like all other medicines, overdosage include: pallor, sweating, Do not leave it in the car or on may cause unwanted side effects in burning throat, nausea, salivation, windowsills. Heat and dampness some people. vomiting, stomach upset or can destroy some medicines. Some effects, such as headache, abdominal pain, diarrhoea, headache, Keep it where children cannot reach irritability, sleep disturbances and dizziness, hearing and vision it.A locked cupboard at least one- light-headedness or dizziness, may disturbances, tremor, confusion, and-a-half metres above the ground be withdrawal symptoms due to low weakness, seizures (fits), fast or is a good place to store medicines. nicotine levels. irregular heartbeat, circulatory problems, fainting and breathing Most of the undesirable effects Disposal difficulties. reported by users of nicotine gums If your pharmacist or doctor tells you The risk of overdose is small as occur during the first few weeks after to stop using the gum or you find that beginning treatment and may be due nausea and vomiting usually occurs it has passed the expiry date, ask at an early stage with excessive to chewing incorrectly or to the your pharmacist what to do with any effects of nicotine. Such effects nicotine intake. gum that is left over. include dizziness, headache, stomach Nicotinell Liquorice Chewing Gum: trouble such as nausea, vomiting, Individuals who are liquorice- indigestion or heartburn, increased sensitive, along with those who chew saliva, hiccups, jaw muscle ache and more Nicotinell Liquorice Chewing Product description a sore mouth or throat. Gum than is recommended, may Some less common side effects of experience symptoms of water Nicotinell Chewing Gum is available nicotine are rapid or irregular retention, headache, vertigo, in two nicotine dosage strengths - heartbeat, palpitations, tingling in the increased urination, increased blood Nicotinell 2 mg gum and Nicotinell 4 fingers or toes, redness or rash of the pressure and general weakness. If mg gum. skin, hives (urticaria) and allergic you experience such symptoms, stop You can choose from four great reactions. using the gums and consult a doctor. flavours in both dosage strengths: If you get chest pain, irregular Children: It is very important to keep Classic, Fruit, and Liquorice. heartbeat or bad indigestion, do not Nicotinell Chewing Gum out of the All Nicotinell Chewing Gums smoke or use Nicotinell or any other reach and sight of children, as doses contain nicotine, chewing nicotine medication. See your of nicotine that are tolerated by adult (containing butylated pharmacist or doctor as soon as smokers can cause severe poisoning hydroxytoluene), calcium carbonate, possible. in small children and can be fatal. carnauba , gelatin, glycerol, Other side effects not listed above In the event of overdose or , , polacrilin, sodium may also occur in some people. Tell suspected overdose, seek bicarbonate, sodium carbonate your pharmacist or doctor if these or immediate medical advice or anhydrous, sorbitol, talc, titanium any other side effects do not go contact a Poisons Information dioxide, water - purified, . away, or if you notice anything else Centre (telephone: Australia 13 11 Classic Nicotinell Chewing Gum that is making you feel unwell. 26; New Zealand 0800 764 766). contains .

Nicotinell® Published by MIMS/myDr August 2009 4 Fruit, Mint and Liquorice Nicotinell Nicotinell Chewing Gums contain saccharin, Try these other flavours in the saccharin sodium and acesulfamine Nicotinell range potassium. • Classic Flavours: Fruit - fruit flavour. Mint - • Fruit , oil. • Mint Liquorice - eucalyptus oil, anise oil, • Liquorice liquorice root extract. Classic - mild Visit our website: fruit flavour. www.nicotinell.com.au All Nicotinell Chewing Gums are This leaflet was prepared in April sugar-free. 2009. Each gum contains sorbitol, xylitol and mannitol with a combined total of 0.4g per piece. For the 2mg strength, this is equivalent to 8g per maximum dose of 20 pieces. For the 4mg strength, this is equivalent to 4g per maximum dose of 10 pieces. Please note that products containing these ingredients may have a laxative effect or cause diarrhoea. Each piece of gum also contains 11.5 mg (0.5 mmol) sodium which should be taken into account by those on a low sodium diet. For the 2 mg strength, this is equivalent to 230 mg (10 mmol) sodium per maximum dose of 20 pieces. For the 4 mg strength, this is equivalent to 115 mg (5mmol) sodium per maximum dose of 10 pieces.

For more information

Ask your pharmacist or doctor if you have any questions, or if you experience any difficulties before, during or after using Nicotinell Chewing Gum as they have more complete information. Nicotinell Chewing Gum is supplied by: Novartis Consumer Health Australasia Pty Ltd ABN 46 004 535 513 327 - 333 Police Road Mulgrave VIC 3170, Australia NZ Office: Auckland, New Zealand Toll-free phone: Australia: 1800 069 643 New Zealand: 0800 700 222

Nicotinell® Published by MIMS/myDr August 2009 5