NICOTINELL FRUIT 4MG MEDICATED CHEWING GUM
Active substance: NICOTINE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
63 mm
NICOTINE
Medicated chewing-gums
FRUIT 4 mg MINT 4 mg ICEMINT 4 mg
Read all of this leaet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nicotinell chewinggum carefully to get the best results from it. Keep this leaet. You may need to read it again. Ask your doctor, nurse or pharmacist if you need more information or advice. If any of the side effects gets serious, or if you notice any side effect not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Nicotinell chewing-gum is and what it is used for 2. Before you take Nicotinell chewing-gum 3. How to take Nicotinell chewing-gum 4. Possible side effects 5. How to store Nicotinell chewing-gum 6. Further information 1 What Nicotinell chewing-gum is and what it is used for Nicotinell medicated chewing-gum is a nicotine replacement therapy (NRT) which is used to help you to stop smoking. It is available in two strengths (2 mg and 4 mg) and ve avours (Fruit, Mint, Icemint, Liquorice and Classic). This leaet is for Nicotinell Fruit, Mint and Icemint, 4mg medicated chewing-gums. The chewing-gum contains nicotine, which is one of the substances in tobacco. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. Nicotinell chewing-gum does not contain the other harmful substances found in tobacco smoke such as tar and carbon monoxide. Nicotinell 4mg gum can be used to help you: stop smoking completely cut down the amount you smoke - perhaps before you go on to stop completely. In addition, they may be used when you: do not wish to smoke. For example in conned spaces (in the car: in the house) or where others (such as children) could be harmed by tobacco smoke are unable to smoke develop cravings once you have stopped smoking. Reducing the number of cigarettes smoked can increase the chances that you will move on to quit completely. Nicotinell 4mg gum is for smokers smoking more than 30 cigarettes per day. It can also be used by smokers smoking between 20 and 30 cigarettes per day, and by those who have previously failed to stop smoking with the aid of nicotine replacement therapy. If you smoke less than 20 cigarettes per day then you should use Nicotinell 2mg medicated chewing-gum. Smokers of more than 20 cigarettes per day, who are reducing their smoking prior to a quit attempt, should use the lower strength Nicotinell 2mg gums once they have successfully reduced the number of cigarettes smoked per day. Nicotinell 2mg and 4mg gums can also be used to relieve breakthrough cravings of smokers attempting to quit by following a patch programme. You might feel a sudden craving to smoke long after you have given up smoking and stopped using Nicotinell gums.Remember you can use any nicotine replacement therapy again if this should happen. If you need advice before starting to use Nicotinell gum, talk to your doctor, nurse, pharmacist or trained counsellor. To help quit smoking you should also try to use a behavioural support programme to increase your chances of success. Talk to your doctor, nurse, pharmacist or a trained counsellor about this.
2 Before you take Nicotinell chewing-gum Do NOT take Nicotinell chewing-gum if you are allergic (hypersensitive) to nicotine or any of the other ingredients of the chewing-gum a non-smoker or occasional smoker under 12 years of age, except on the advice of a doctor. Take special care with Nicotinell chewing-gum Please speak with your doctor, nurse or pharmacist before taking the chewing-gum if you: have heart disease, (e.g. heart attack, disorders of the heart rate and/or rhythm) have or had a stroke have serious liver or kidney disease have or had a stomach ulcer have persistent indigestion have a severe sore throat or inammation of the mouth are diabetic (see next section) have an overactive thyroid gland have a tumour of the adrenal glands (pheochromocytoma) are fructose intolerance are on a low-sodium diet are taking any other medicines (see next section) are pregnant or breast-feeding (see Pregnancy/Breast-feeding sections). Some denture wearers may experience difculty in chewing the gum. If you do, it is recommended that you use a different form of nicotine replacement therapy, such as a patch or lozenge. Ask your doctor or pharmacist for advice. Using nicotine replacement therapy is better than continuing to smoke. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of some medicines can be altered when you stop smoking. If you are already taking regular medication you should tell your doctor, nurse or pharmacist. Diabetics should monitor their blood sugar levels more often than usual when taking chewing gum because your insulin/medication requirements may alter. Taking Nicotinell chewing-gum with food and drink Coffee, juices, acidic and zzy drinks may reduce the absorption of nicotine and should not be taken for 15 minutes before chewing the gum. Pregnancy Smoking during pregnancy is associated with risks such as poor growth of the baby before birth, premature birth or still birth. Stopping smoking is the single most effective way to improve both your health and that of your baby. The earlier smoking stops, the better. Ideally, stopping smoking during pregnancy should be done without nicotine replacement therapy. However, if you have tried and this is not possible, nicotine replacement therapy may be used because the risk to the developing baby is less than that expected from continued smoking. The decision to use nicotine replacement therapy should be made as early on in the pregnancy as possible with the aim of discontinuing use after 2-3 months. Ask your doctor for advice before taking any medicine. Breast-feeding It is better to use nicotine replacement therapy products that can be taken intermittently (not
385mm
ON FOR THE USER
edicated chewing-gums
UIT 4 mg NT 4 mg EMINT 4 mg
patches). Try to breast-feed at a time just before you take the product to ensure that the baby gets the smallest amount of nicotine possible. If you need to use nicotine replacement therapy to help you give up smoking, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would otherwise be breathing in. Driving and using machines The chewing gum is unlikely to affect your ability to drive or operate machinery. Important information about some of the ingredients of Nicotinell Medicated chewing gum These chewing-gums contain some ingredients of which you may need to be aware of: sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Each piece of fruit and mint avour gum contains 0.2g, a source of 0.04 g fructose. Each piece of Ice mint avour gum contains 0.1g, a source of 0.02 g fructose. sodium: Each piece of fruit and mint avour gum contains 11.5 mg per piece. Each piece of Icemint avour gum contains 11.45 mg per piece.To be taken into consideration by those on a controlled sodium diet butylhydroxytoluene (E321): an ingredient of the gum base of Nicotinell Icemint avour gums which may cause local irritation to the lining of the mouth. For other ingredients see Section 6. 3 How to take Nicotinell chewing-gum Chew one piece of gum when you feel the urge to smoke. It is important to chew the gum correctly, not like ordinary chewing-gum. Follow the instructions below and do NOT swallow the gum: Chewing technique: 1. Chew one piece of gum slowly until the taste becomes strong. 2. Rest between your gum and cheek. 3. Chew again when taste has faded. 4. Repeat this chewing routine for about 30 minutes. Most people use 8 12 pieces of 4mg gum a day. Do NOT use more than 1 piece of gum at a time or more than 15 pieces of 4 mg gum a day. Remember not to drink certain drinks 15 minutes before chewing the gum (see Section 2). The gum can stick to and very rarely damage dentures or other dental work. You may prefer to use a patch or lozenge. After 3 months, you should gradually reduce the number of pieces of gum chewed each day. You should stop using the gum when you are only taking 1-2 pieces of gum per day. Counselling may improve your chances of giving up smoking. Children and adolescents (12 -18 years) should only use the gum for 12 weeks. If longer is required then talk to your doctor, nurse or pharmacist. Children under 12 years should not use the gum unless advised by a doctor. If you take more Nicotinell chewing-gums than you should If you accidentally take too many, or if a child has eaten any, contact your doctor or nearest hospital casualty department immediately, take the pack or leaet with you if possible. The general symptoms of nicotine overdose include: headache, sickness, diarrhoea and stomach pains If you forget to use Nicotinell chewing-gums Only chew the gum when you need to. Do NOT use more than 1 piece of gum at a time or more than 15 pieces of 4 mg gum a day. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4 Possible side effects Like all medicines, Nicotinell chewing-gums can cause side effects, although not everybody gets them. STOP using the gum and seek medical help immediately if you have any of the following very
ly because it on for you.
2 Before you take Nicotinell chewing-gum Do NOT take Nicotinell chewing-gum if you are allergic (hypersensitive) to nicotine or any of the other ingredients of the chewing-gum a non-smoker or occasional smoker under 12 years of age, except on the advice of a doctor. Take special care with Nicotinell chewing-gum Please speak with your doctor, nurse or pharmacist before taking the chewing-gum if you: have heart disease, (e.g. heart attack, disorders of the heart rate and/or rhythm) have or had a stroke have serious liver or kidney disease have or had a stomach ulcer have persistent indigestion have a severe sore throat or inammation of the mouth are diabetic (see next section) have an overactive thyroid gland have a tumour of the adrenal glands (pheochromocytoma) are fructose intolerance are on a low-sodium diet are taking any other medicines (see next section) are pregnant or breast-feeding (see Pregnancy/Breast-feeding sections). Some denture wearers may experience difculty in chewing the gum. If you do, it is recommended that you use a different form of nicotine replacement therapy, such as a patch or lozenge. Ask your doctor or pharmacist for advice. Using nicotine replacement therapy is better than continuing to smoke. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of some medicines can be altered when you stop smoking. If you are already taking regular medication you should tell your doctor, nurse or pharmacist. Diabetics should monitor their blood sugar levels more often than usual when taking chewing gum because your insulin/medication requirements may alter. Taking Nicotinell chewing-gum with food and drink Coffee, juices, acidic and zzy drinks may reduce the absorption of nicotine and should not be taken for 15 minutes before chewing the gum. Pregnancy Smoking during pregnancy is associated with risks such as poor growth of the baby before birth, premature birth or still birth. Stopping smoking is the single most effective way to improve both your health and that of your baby. The earlier smoking stops, the better. Ideally, stopping smoking during pregnancy should be done without nicotine replacement therapy. However, if you have tried and this is not possible, nicotine replacement therapy may be used because the risk to the developing baby is less than that expected from continued smoking. The decision to use nicotine replacement therapy should be made as early on in the pregnancy as possible with the aim of discontinuing use after 2-3 months. Ask your doctor for advice before taking any medicine. Breast-feeding It is better to use nicotine replacement therapy products that can be taken intermittently (not
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rare allergic reactions: difculty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat. severe itching of the skin, with a red rash or raised lumps. Some mild effects you may notice in the rst 3-4 weeks are: palpitations, red skin rash, itching of raised bumps of the skin, dizziness, headache and sleep disturbances. slight irritation of the throat and increase in saliva when you start using the gum These may be withdrawal symptoms directly caused by giving up smoking. Excessive consumption in those who smoked but did not inhale may cause: feeling sick, faintness, headache Intense chewing may give you the following if your chewing technique is not correct: dryness of the mouth, hiccups, stomach trouble such as nausea, vomiting, heartburn, increased saliva production, irritation of the mouth and throat, jaw muscle ache. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5 How to store Nicotinell chewing-gum Keep out of the reach and sight of children. Do not use Nicotinell gums after the expiry date which is stated on the blister pack and box after EXP. The expiry date refers to the last day of that month. Do not store above 25C. To dispose of used gum, wrap in paper before putting into a waste bin. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6 Further information What Nicotinell chewing-gum contains The active substance is nicotine. Each piece of Nicotinell medicated chewing-gum contains 4mg of nicotine in a resin complex (as 20mg nicotine polacrilin). The other ingredients of Nicotinell Fruit and Mint avoured gums are gum base, calcium carbonate (E170), sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate (E500), glycerol (E422), levomenthol, butylhydroxytoluene (E321), saccharin, saccharin sodium (E954), acesulfame potassium (E950), xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax (E903), talc (E553b), water. The other ingredients of Nicotinell Icemint avour gums are: gum base (containing butylhydroxytoluene (E321)), calcium carbonate (E170), sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate (E500), polacrilin, glycerol (E422), puried water, levomenthol, sucralose (E955), acesulfame potassium (E950), xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax (E903) and talc (E553b). (see also Section 2 for further ingredient information). What Nicotinell chewing-gum looks like and contents of the pack Each piece of chewing-gum is off-white in colour and rectangular in shape. The Fruit, Mint and Icemint 4mg Gums are packed in blisters inside boxes containing 12, 24, 36, 72, 96, 120 and 204 pieces of gum. Not all pack sizes may be marketed. Marketing Authorisation Holder Novartis Consumer Health, Horsham, RH12 5AB, UK. Marketing Authorisation Holder FAMAR S.A., 48th km Athens-Lamia, 19011, Avlona, Greece. Help/Advice You can also nd additional information and support @ www.smokefree.nhs.uk or by calling the NHS helpline on 0800 0224322. This leaet was last approved March 2012.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

