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Nicorette Freshmint Gum 2mg (pack of 30) |
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Relief of nicotine withdrawal symptoms during smoking cessation. Suitable for use by smokers able to stop abruptly and those wanting to cut down cigarette use before stopping.
Adults and children over 12 years: Chew each piece slowly for 30 minutes according to the chew and rest technique described on the pack when there is an urge to smoke. Maximum 15 piece daily, but usual daily usage is 8-12 pieces. If more than 15 pieces daily were required recommended 4mg strength.
Product information leaflet:
http://emc.medicines.org.uk/medicine/20677/SPC/Nicorette Freshmint 2mg Gum/
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Chewing Gum containing 2mg nicotine, as nicotine resinate
Medicated Chewing Gum
Nicorette Freshmint 2mg Gum is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).
In smokers currently unable or not ready to stop smoking abruptly, the gum may also be used as part of a programme to reduce smoking prior to stopping completely.
If possible, Nicorette Freshmint 2mg Gum should be used in conjunction with a behavioural support programme.
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Nicorette Freshmint 2 mg Gum should be chewed slowly according to the instructions.
The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2mg nicotine gum is indicated. If more that 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.
The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.
Behavioural therapy, advice and support will normally improve the success rate.
Smoking cessation
Adults (over 18 years of age)
The patient should make every effort to stop smoking completely during treatment with Nicorette Freshmint 2mg Gum.
Use the gum whenever there is an urge to smoke to maintain complete abstinence from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.
Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 1-2 gums, use should be stopped.
For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.
Any spare gum should be retained, as craving may suddenly return. Adults who use NRT beyond 9 months for smoking cessation are recommended to seek additional help and advice from a healthcare professional.
Adolescents (12 to 18 years)
The patient should make every effort to stop smoking completely during treatment with Nicorette Freshmint 2mg Gum.
Use the gum whenever there is an urge to smoke to maintain complete abstinence from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.
Continue use for up to 8 weeks to break the habit of smoking, then gradually reduce gum use over a 4 week period. When daily use is 1-2 gums, use should be stopped.
For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.
As data are limited in this age group, the recommended duration of treatment is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.
Smoking reduction
Adults (over 18 years of age)
Use the gum between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.
A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.
When making a quit attempt the smoking cessation instructions above can be followed.
Adolescents (12 to 18 years)
Where adolescents are motivated to stop smoking abruptly, smoking cessation should be recommended. However, smoking reduction can be considered where adolescents are not ready or able to stop smoking abruptly. As data are limited in this age group, and the recommended duration of NRT is 12 weeks, adolescents should consult a healthcare professional before starting the “smoking reduction prior to stopping” regimen.
Use the gum between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.
A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.
When making a quit attempt the smoking cessation instructions for adolescents (12 to 18 years) given above can be followed.
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Hypersensitivity to any component of the chewing gum
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Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshmint 2mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshmint 2mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Renal or hepatic impairment: Nicorette Freshmint 2mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshmint 2mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.
Excipients: Nicorette Freshmint 2mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.
Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshmint 2mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.
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