Nicorette Freshmint 4 mg Gum or NicAssist Minty Fresh 4 mg Gum

Chewing Gum containing 4mg nicotine, as nicotine resinate.

For excipients see section 6.1

Medicated Chewing Gum

Nicorette Freshmint 4mg 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 4mg Gum should be used in conjunction with a behavioural support programme.

Nicorette Freshmint 4 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 4mg 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 4mg 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.

Hypersensitivity to any component of the chewing gum.

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 4mg 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 4mg 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 4mg 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 4mg 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 4mg 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 4mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

Pregnancy

NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.

Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the women is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.

Lactation

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.

Not applicable.

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Freshmint 4mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshmint 4mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Freshmint 4mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshmint 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

Core Gum

Polacrilin

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Quinoline yellow Al lake (E104)

Talcum

Nitrogen, food grade

Coating

Xylitol

Peppermint oil

Acacia

Titanium dioxide (E171)

Carnauba wax

Quinoline yellow Al lake (E104)

None known

2 Years

Do not store above 25^oC

Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.

Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.

Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.

Not all pack sizes may be marketed.

See section 4.2

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

PL 15513/0174

21 January 2008

11^th February 2010