NICORETTE FRESHMINT 2MG GUM
Active substance: NICOTINE - RESIN COMPLEX
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651263 When you chew NICORETTE gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE gum will not give you the buzz you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking For the best effect, make sure you chew NICORETTE gum correctly. See How to chew NICORETTE (gum - the NICORETTE chewing technique. The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. You may 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 of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning. Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, 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 trying 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. adrenal gland that can affect blood pressure) your doctor will have told you this. if you have diabetes monitor your blood sugar levels more often when starting to use NICORETTE gum as you may find your insulin or medication requirements alter. if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted. If any of these applies, talk to your doctor, nurse or pharmacist.
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nicorette freshmint 2 mg gum (2 mg nicotine chewing gum) nicorette freshmint 4 mg gum (4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
freshmint 2 mg and 4 mg gum What you should know about
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
1What the medicine is for
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, Where you dont want to smoke and avoid harm to others e.g children or family. Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, the 4 mg nicotine gum may be more appropriate.
!
If you are pregnant or breast-feeding
2Before using this medicine
X Do not use nicorette gum:
if you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke. if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the
If you are pregnant: 1) Firstly, you should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) Secondly, if you cant manage this, you can use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum, may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) Firstly, you should try to give up smoking without NRT. 2) Secondly, if you cant manage this you are best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
to the How to stop smoking: your choice section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum - the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
i i
Children under 12 years
Do not give this product to children under 12 years.
Adults and Children 12 years and over
Dose of Gums One 2 mg gum as required to relieve cravings. One 4 mg gum as required to relieve cravings.
Number of cigarettes you smoke per day 20 cigarettes or fewer More than 20 cigarettes
Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were.
i
How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you.
3How and when to use this medicine
i
What does nicorette gum do?
When to use nicorette gum
The following sections contain the dosage information for NICORETTE. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go
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When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine.
The nicorette chewing technique
1. Chew slowly until taste becomes strong. 2. Rest between gum and cheek. 3. Chew again when the taste has faded.
turn over
651263 Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully. i How to stop smoking: If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
!
!
These effects include:
irritability or aggression feeling low anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
Effects of too much nicotine
!
If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted sideeffects via the internet at www.mhra.gov.uk/ yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Who makes Nicorette Gum?
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in August 2012.
Information about nicorette ActiveStop
NICORETTE ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access and a mobile telephone. Call 0800 244 838 for information
You may also get these effects if you are not used to inhaling tobacco smoke.
5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box or blister strip. Dispose of NICORETTE gum sensibly. Medicines should not be disposed of via waster water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
These effects include:
feeling faint feeling sick (nausea) headache hiccupping (due to excessive swallowing of nicotine).
Side-effects of nicorette gum
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine. The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine. Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour). None of the gums contain sugar (sucrose) or animal products).
If you have used too many gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you do get any of these effects contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) hiccups
!
If a child has used or swallowed the gums
Contact a doctor or your nearest hospital Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
Common side-effects:
(less than 1 in every 10 people are affected) dizziness sickness (vomiting).
Uncommon side-effect:
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
4Possible side-effects
(less than 1 in every 100 people are affected) hives (urticaria), redness or itching of the skin chest palpitations.
What the medicine looks like
Rare side-effects
(less than 1 in 1,000 people are affected) allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of skin, ulceration and inflammation of the lining of the mouth).
Effects related to stopping smoking (nicotine withdrawal)
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
Very rare side-effects
(less than 1 in 10,000 people are affected) abnormal beating of the heart.
NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
freshmint 2 mg and 4 mg gum Nicotine chewing gum What you should know about nicorette freshmint 2 mg gum
(2 mg nicotine chewing gum)
nicorette freshmint 4 mg gum
(4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
1What the medicine is for
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, - Where you dont want to smoke and avoid harm to others e.g children or family. - Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, 4 mg nicotine gum may be more appropriate.
you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking For the best effect, make sure you chew NICORETTE gum correctly. See How to chew NICORETTE gum the NICORETTE chewing technique. The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. You may 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 of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning. Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, 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 trying 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.
dermatitis) or irritation to the eyes and mucous membranes.
!
If you are pregnant or breast-feeding
2Before using this medicine
X Do
not use nicorette gum:
If you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke. if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) your doctor will have told you this. if you have diabetes monitor your blood sugar levels more often when starting to use NICORETTE gum as you may find your insulin or medication requirements alter. if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted. f any of these applies, talk to your doctor, I nurse or pharmacist.
If you are pregnant: 1) irstly, you should try to give up smoking F without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) econdly, if you cant manage this, you can S use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) irstly, you should try to give up smoking F without NRT. 2) econdly, if you cant manage this you are S best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
i
Children under 12 years
Do not give this product to children under 12 years.
i
Adults and Children 12 years and over
Number of Dose of Gums cigarettes you smoke per day 20 cigarettes One 2 mg gum as or fewer required to relieve cravings. More than One 4 mg gum as 20 cigarettes required to relieve cravings. Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were
i
How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you.
3How and when to use this medicine
i
When to use nicorette gum
The following sections contain the dosage information for NICORETTE gum. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go to the How to stop smoking section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures
turn over
What does nicorette gum do?
When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you chew NICORETTE gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE gum will not give you the buzz
!
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact
651212
i
The nicorette chewing technique
1.Chew slowly until taste becomes strong. 2.Rest between gum and cheek. 3.Chew again when the taste has faded. Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.
anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
i
How to stop smoking
Effects of too much nicotine
!
For the gums in loose-filled cardboard boxes, dispose of within 3 months of opening. Dispose of NICORETTE gum sensibly. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
You may also get these effects if you are not used to inhaling tobacco smoke.
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour). None of the gums contain sugar (sucrose) or animal products.
These effects include:
feeling faint feeling sick (nausea) headache hiccuping (due to excessive swallowing of nicotine)
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
Side-effects of nicorette gum
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) hiccups
What the medicine looks like
Common side-effects:
(less than 1 in every 10 people are affected) dizziness and sickness (vomiting)
Uncommon side-effects:
!
If you have used too many gums
!
If a child has used or swallowed the gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, Rare side-effects: hearing disturbance or weakness. (less than 1 in 1,000 people are affected) f you do get any of these effects contact a I allergic reactions (swelling of the mouth, doctor or your nearest hospital Accident and lips, throat and tongue, itching of the skin, Emergency department immediately. Take swelling of skin, ulceration and inflammation this leaflet and the pack with you. of the lining of the mouth)
(less than 1 in every 100 people are affected) hives (urticaria) redness or itching of the skin chest palpitations
NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
Who makes nicorette gum?
Very rare side-effects:
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in June 2012 .
ontact a doctor or your nearest hospital C Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
4Possible side-effects
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
!
Effects related to stopping smoking (nicotine withdrawal)
(less than 1 in 10,000 people are affected) abnormal beating of the heart If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Information about nicorette ActiveStop
NICORETTE ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access. Call 0800 244 838 for information
5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box.
These effects include:
irritability or aggression feeling low
651215 When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you chew NICORETTE gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE gum will not give you the buzz you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking For the best effect, make sure you chew NICORETTE gum correctly. See How to chew NICORETTE gum the NICORETTE chewing technique. The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. You may 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 of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning. Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, 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 trying 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.
What does nicorette gum do?
freshmint 2 mg and 4 mg gum Nicotine chewing gum What you should know about nicorette freshmint 2 mg gum
(2 mg nicotine chewing gum)
nicorette freshmint 4 mg gum
(4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) your doctor will have told you this. if you have diabetes monitor your blood sugar levels more often when starting to use NICORETTE gum as you may find your insulin or medication requirements alter. if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted. If any of these applies, talk to your doctor, nurse or pharmacist.
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3How and when to use this medicine
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When to use nicorette gum
The following sections contain the dosage information for NICORETTE gum. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go to the How to stop smoking section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
1What the medicine is for
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, - Where you dont want to smoke and avoid harm to others e.g children or family. - Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, 4 mg nicotine gum may be more appropriate.
!
If you are pregnant or breast-feeding
If you are pregnant: 1) Firstly, you should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) Secondly, if you cant manage this, you can use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) Firstly, you should try to give up smoking without NRT. 2) Secondly, if you cant manage this you are best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
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Children under 12 years
Do not give this product to children under 12 years.
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Adults and Children 12 years and over
Dose of Gums One 2 mg gum as required to relieve cravings. One 4 mg gum as required to relieve cravings.
2Before using this medicine
X Do not use nicorette gum:
If you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Number of cigarettes you smoke per day 20 cigarettes or fewer More than 20 cigarettes
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke.
Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were.
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How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. turn over
651215 If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you. i The nicorette chewing technique 1. Chew slowly until taste becomes strong. 2. Rest between gum and cheek. 3. Chew again when the taste has faded. Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.
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4Possible side-effects
Rare side-effects:
(less than 1 in 1,000 people are affected) allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of skin, ulceration and inflammation of the lining of the mouth).
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
None of the gums contain sugar (sucrose) or animal products. NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
What the medicine looks like
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
!
Effects related to stopping smoking (nicotine withdrawal)
Very rare side-effects:
How to stop smoking
If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
These effects include:
irritability or aggression feeling low anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
(less than 1 in 10,000 people are affected) abnormal beating of the heart If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/ yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Who makes nicorette gum?
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in June 2012 .
Effects of too much nicotine
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5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box. Dispose of NICORETTE gum sensibly. For the gums in loose-filled cardboard boxes, dispose of within 3 months of opening. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
You may also get these effects if you are not used to inhaling tobacco smoke.
Information about nicorette ActiveStop
These effects include:
feeling faint feeling sick (nausea) headache hiccuping (due to excessive swallowing of nicotine)
Nicorette ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access. Call 0800 244 838 for information
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If you have used too many gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you do get any of these effects contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
Side-effects of nicorette gum
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) and hiccups
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour).
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If a child has used or swallowed the gums
Contact a doctor or your nearest hospital Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
Common side-effects:
(less than 1 in every 10 people are affected) dizziness sickness (vomiting)
Uncommon side-effects:
(less than 1 in every 100 people are affected) hives (urticaria), redness or itching of the skin chest palpitations
!
nicorette freshmint 2 mg gum (2 mg nicotine chewing gum) nicorette freshmint 4 mg gum (4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
freshmint 2 mg and 4 mg gum What you should know about
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
1What the medicine is for
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, Where you dont want to smoke and avoid harm to others e.g children or family. Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, the 4 mg nicotine gum may be more appropriate.
!
If you are pregnant or breast-feeding
2Before using this medicine
X Do not use nicorette gum:
if you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke. if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the
If you are pregnant: 1) Firstly, you should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) Secondly, if you cant manage this, you can use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum, may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) Firstly, you should try to give up smoking without NRT. 2) Secondly, if you cant manage this you are best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
to the How to stop smoking: your choice section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum - the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
i i
Children under 12 years
Do not give this product to children under 12 years.
Adults and Children 12 years and over
Dose of Gums One 2 mg gum as required to relieve cravings. One 4 mg gum as required to relieve cravings.
Number of cigarettes you smoke per day 20 cigarettes or fewer More than 20 cigarettes
Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were.
i
How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you.
3How and when to use this medicine
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What does nicorette gum do?
When to use nicorette gum
The following sections contain the dosage information for NICORETTE. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go
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When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine.
The nicorette chewing technique
1. Chew slowly until taste becomes strong. 2. Rest between gum and cheek. 3. Chew again when the taste has faded.
turn over
651263 Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully. i How to stop smoking: If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
!
!
These effects include:
irritability or aggression feeling low anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
Effects of too much nicotine
!
If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted sideeffects via the internet at www.mhra.gov.uk/ yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Who makes Nicorette Gum?
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in August 2012.
Information about nicorette ActiveStop
NICORETTE ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access and a mobile telephone. Call 0800 244 838 for information
You may also get these effects if you are not used to inhaling tobacco smoke.
5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box or blister strip. Dispose of NICORETTE gum sensibly. Medicines should not be disposed of via waster water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
These effects include:
feeling faint feeling sick (nausea) headache hiccupping (due to excessive swallowing of nicotine).
Side-effects of nicorette gum
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine. The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine. Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour). None of the gums contain sugar (sucrose) or animal products).
If you have used too many gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you do get any of these effects contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) hiccups
!
If a child has used or swallowed the gums
Contact a doctor or your nearest hospital Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
Common side-effects:
(less than 1 in every 10 people are affected) dizziness sickness (vomiting).
Uncommon side-effect:
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
4Possible side-effects
(less than 1 in every 100 people are affected) hives (urticaria), redness or itching of the skin chest palpitations.
What the medicine looks like
Rare side-effects
(less than 1 in 1,000 people are affected) allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of skin, ulceration and inflammation of the lining of the mouth).
Effects related to stopping smoking (nicotine withdrawal)
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
Very rare side-effects
(less than 1 in 10,000 people are affected) abnormal beating of the heart.
NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
freshmint 2 mg and 4 mg gum Nicotine chewing gum What you should know about nicorette freshmint 2 mg gum
(2 mg nicotine chewing gum)
nicorette freshmint 4 mg gum
(4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
1What the medicine is for
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, - Where you dont want to smoke and avoid harm to others e.g children or family. - Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, 4 mg nicotine gum may be more appropriate.
you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking For the best effect, make sure you chew NICORETTE gum correctly. See How to chew NICORETTE gum the NICORETTE chewing technique. The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. You may 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 of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning. Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, 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 trying 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.
dermatitis) or irritation to the eyes and mucous membranes.
!
If you are pregnant or breast-feeding
2Before using this medicine
X Do
not use nicorette gum:
If you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke. if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) your doctor will have told you this. if you have diabetes monitor your blood sugar levels more often when starting to use NICORETTE gum as you may find your insulin or medication requirements alter. if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted. f any of these applies, talk to your doctor, I nurse or pharmacist.
If you are pregnant: 1) irstly, you should try to give up smoking F without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) econdly, if you cant manage this, you can S use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) irstly, you should try to give up smoking F without NRT. 2) econdly, if you cant manage this you are S best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
i
Children under 12 years
Do not give this product to children under 12 years.
i
Adults and Children 12 years and over
Number of Dose of Gums cigarettes you smoke per day 20 cigarettes One 2 mg gum as or fewer required to relieve cravings. More than One 4 mg gum as 20 cigarettes required to relieve cravings. Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were
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How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you.
3How and when to use this medicine
i
When to use nicorette gum
The following sections contain the dosage information for NICORETTE gum. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go to the How to stop smoking section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures
turn over
What does nicorette gum do?
When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you chew NICORETTE gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE gum will not give you the buzz
!
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact
651212
i
The nicorette chewing technique
1.Chew slowly until taste becomes strong. 2.Rest between gum and cheek. 3.Chew again when the taste has faded. Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.
anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
i
How to stop smoking
Effects of too much nicotine
!
For the gums in loose-filled cardboard boxes, dispose of within 3 months of opening. Dispose of NICORETTE gum sensibly. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
You may also get these effects if you are not used to inhaling tobacco smoke.
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour). None of the gums contain sugar (sucrose) or animal products.
These effects include:
feeling faint feeling sick (nausea) headache hiccuping (due to excessive swallowing of nicotine)
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
Side-effects of nicorette gum
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) hiccups
What the medicine looks like
Common side-effects:
(less than 1 in every 10 people are affected) dizziness and sickness (vomiting)
Uncommon side-effects:
!
If you have used too many gums
!
If a child has used or swallowed the gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, Rare side-effects: hearing disturbance or weakness. (less than 1 in 1,000 people are affected) f you do get any of these effects contact a I allergic reactions (swelling of the mouth, doctor or your nearest hospital Accident and lips, throat and tongue, itching of the skin, Emergency department immediately. Take swelling of skin, ulceration and inflammation this leaflet and the pack with you. of the lining of the mouth)
(less than 1 in every 100 people are affected) hives (urticaria) redness or itching of the skin chest palpitations
NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
Who makes nicorette gum?
Very rare side-effects:
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in June 2012 .
ontact a doctor or your nearest hospital C Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
4Possible side-effects
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
!
Effects related to stopping smoking (nicotine withdrawal)
(less than 1 in 10,000 people are affected) abnormal beating of the heart If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Information about nicorette ActiveStop
NICORETTE ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access. Call 0800 244 838 for information
5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box.
These effects include:
irritability or aggression feeling low
651215 When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you chew NICORETTE gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE gum will not give you the buzz you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking For the best effect, make sure you chew NICORETTE gum correctly. See How to chew NICORETTE gum the NICORETTE chewing technique. The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. You may 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 of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning. Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, 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 trying 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.
What does nicorette gum do?
freshmint 2 mg and 4 mg gum Nicotine chewing gum What you should know about nicorette freshmint 2 mg gum
(2 mg nicotine chewing gum)
nicorette freshmint 4 mg gum
(4 mg nicotine chewing gum) Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach). if you have liver or kidney disease. if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) your doctor will have told you this. if you have diabetes monitor your blood sugar levels more often when starting to use NICORETTE gum as you may find your insulin or medication requirements alter. if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted. If any of these applies, talk to your doctor, nurse or pharmacist.
!
3How and when to use this medicine
i
When to use nicorette gum
The following sections contain the dosage information for NICORETTE gum. This shows the number of gums you should be using, when you should take them, how you should take them and the maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for. Please read this information carefully and then go to the How to stop smoking section, which will help you decide which method to use to give up smoking. Use the How to chew NICORETTE gum the NICORETTE chewing technique instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum. The number of NICORETTE gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take. The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the NICORETTE gums they are using. The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.
1What the medicine is for
Some of the ingredients can cause problems
The chewing gum base contains butylated hydroxy toluene (E321), an anti-oxidant. May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
NICORETTE gum is a nicotine replacement therapy (NRT). It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see If you are pregnant or breast-feeding section. Ideally you should always aim to stop smoking. You can use NICORETTE gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you cant or do not want to smoke. For example, - Where you dont want to smoke and avoid harm to others e.g children or family. - Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE ActiveStop are at the end of this leaflet. If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine gum will help relieve your cravings. If you smoke more than 20 cigarettes a day, 4 mg nicotine gum may be more appropriate.
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If you are pregnant or breast-feeding
If you are pregnant: 1) Firstly, you should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby. 2) Secondly, if you cant manage this, you can use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice. Products that are used intermittently, including NICORETTE gum may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night. If you are breast-feeding: 1) Firstly, you should try to give up smoking without NRT. 2) Secondly, if you cant manage this you are best to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE gum to ensure that the baby gets the smallest amount of nicotine possible. If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
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Children under 12 years
Do not give this product to children under 12 years.
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Adults and Children 12 years and over
Dose of Gums One 2 mg gum as required to relieve cravings. One 4 mg gum as required to relieve cravings.
2Before using this medicine
X Do not use nicorette gum:
If you are a child under 12 years of age. if you have an allergy to nicotine or any of the other ingredients.
!
Number of cigarettes you smoke per day 20 cigarettes or fewer More than 20 cigarettes
Talk to your doctor, nurse or pharmacist
if you are pregnant or breast-feeding you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See If you are pregnant or breast-feeding section. if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke.
Use only one piece of gum at a time. Do not use more than 15 gums per day. The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were.
i
How to chew nicorette gum the nicorette chewing technique
The method of chewing NICORETTE gum is not the same as for ordinary chewing gum. NICORETTE gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups. turn over
651215 If you have false teeth you may have difficulty chewing the gum as NICORETTE gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you. i The nicorette chewing technique 1. Chew slowly until taste becomes strong. 2. Rest between gum and cheek. 3. Chew again when the taste has faded. Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.
i
4Possible side-effects
Rare side-effects:
(less than 1 in 1,000 people are affected) allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of skin, ulceration and inflammation of the lining of the mouth).
Like all medicines, NICORETTE gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
None of the gums contain sugar (sucrose) or animal products. NICORETTE freshmint 2 mg gum is a whitish square coated piece of gum. NICORETTE freshmint 4 mg gum is a crme square coated piece of gum. Pack types and pack sizes: The gums are blister packed in sheets of 6, 10 or 15 and supplied in packs of 10, 12, 15, 30, 105 and 210 pieces. The gums are loose-fill packed in a cardboard box, wrapped in a transparent plastic film, containing 25 pieces and supplied in packs of 25, 100 (4x25) and 200 (8x25). Not all pack types and sizes may be marketed.
What the medicine looks like
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE gum before you are ready to reduce your nicotine intake.
!
Effects related to stopping smoking (nicotine withdrawal)
Very rare side-effects:
How to stop smoking
If you are able to stop smoking you should use NICORETTE gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use NICORETTE gum on those occasions when you cant or dont want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
These effects include:
irritability or aggression feeling low anxiety restlessness poor concentration increased appetite or weight gain urges to smoke (craving) night time awakening or sleep disturbance lowering of heart rate
(less than 1 in 10,000 people are affected) abnormal beating of the heart If you notice these or any other unwanted effects not listed in this leaflet tell your doctor, nurse or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/ yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am 2pm Monday to Friday) or fill in the paper form available from your local pharmacy. When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Who makes nicorette gum?
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is McNeil AB, Helsingborg, Sweden. This leaflet was revised in June 2012 .
Effects of too much nicotine
!
5Storing and disposal
Keep NICORETTE gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children. Do not store NICORETTE gum above 25C. Do not use the gum after the Use before date on the box. Dispose of NICORETTE gum sensibly. For the gums in loose-filled cardboard boxes, dispose of within 3 months of opening. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
You may also get these effects if you are not used to inhaling tobacco smoke.
Information about nicorette ActiveStop
These effects include:
feeling faint feeling sick (nausea) headache hiccuping (due to excessive swallowing of nicotine)
Nicorette ActiveStop is a personalised support programme which works with NICORETTE to support you, with the aim of helping you give up smoking. All you need is internet access. Call 0800 244 838 for information
!
If you have used too many gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you do get any of these effects contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.
NICORETTE gum can sometimes cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation. The gum may occasionally stick to dentures and in rare cases damage them.
Side-effects of nicorette gum
Very common side-effects:
(more than 1 in every 10 people are affected) headache sore mouth or throat jaw-muscle ache stomach discomfort feeling sick (nausea) and hiccups
6Further information
Whats in this medicine?
The active ingredient in NICORETTE freshmint 2 mg gum is 2 mg Nicotine The active ingredient in NICORETTE freshmint 4 mg gum is 4 mg Nicotine Other ingredients are: Chewing gum base, xylitol, acesulfame potassium, sodium carbonate, peppermint oil, menthol, polacrilin, magnesium oxide, titanium dioxide E171 (white colour), talc, acacia and carnauba wax. The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant. The 2 mg gum also contains sodium bicarbonate. The 4 mg gum also contains quinoline yellow (E104) (yellow colour).
!
If a child has used or swallowed the gums
Contact a doctor or your nearest hospital Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you. Nicotine ingestion by a child may result in severe poisoning.
Common side-effects:
(less than 1 in every 10 people are affected) dizziness sickness (vomiting)
Uncommon side-effects:
(less than 1 in every 100 people are affected) hives (urticaria), redness or itching of the skin chest palpitations
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.
