NiQuitin 4 mg Mint Gum.

Chewing gum containing 4 mg nicotine. For excipients see 6.1.

Chewing gum.

Yellow rectangular pillow-shaped gum.

NiQuitin Mint Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Mint Gum is indicated in pregnant and lactating women making a quit attempt.

NiQuitin Mint Gum should preferably be used in conjunction with a behavioural support programme.

Directions for use:

NiQuitin Mint Gum should be chewed slowly according to the instructions.

NiQuitin 4 mg Mint Gum is suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

Behavioural therapy, advice and support will normally improve the success rate.

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.

Adults (18 years and over)

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Gum.

NiQuitin Mint Gum should be chewed as directed whenever there is an urge to smoke to maintain complete abstinence from smoking.

Sufficient gums should be used each day, usually 812, 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 12 gums, use should be stopped. Any spare gum should be retained, as craving may suddenly return.

Those who have quit smoking but are having difficulty discontinuing using the gum are recommended to seek additional help and advice from a healthcare professional.

For those using the 4 mg gum, the 2 mg gum will be helpful during withdrawal from treatment.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly. Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If users are still feeling the need to use the gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a piece of gum whenever there is a strong urge to smoke to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children

Adolescents (12 to 17 years) should follow the above usage advice for abrupt cessation of smoking. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Mint Gum is not recommended for use in children under 12 years of age.

Hypersensitivity to nicotine or any of the other ingredients in this product.

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

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.

Allergic reactions: susceptibility to angioedema and urticaria.

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use 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.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI Disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

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. NiQuitin Mint Gum should be disposed of with care.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Smokers who wear dentures may experience difficulty in chewing NiQuitin Mint Gum.

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

Not applicable.

NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. In relation to this some reported symptoms, such as dizziness, headache and sleep disturbances may be related to withdrawal symptoms associated with abstinence from smoking. Increased frequency of aphthous ulcer may occur after abstinence from smoking.

NiQuitin Mint Gum in the recommended dose has not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Mint Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headache (as may be experienced by such a patient if tobacco smoke is inhaled). Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation. Excessive swallowing of dissolved nicotine may, at first, cause hiccuping.

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

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

ATC Code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing NiQuitin Mint 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 57 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.

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre-and post natal growth retardation and delays and changes in postnatal CNS development. Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin Mint Gum. Effects on fertility have not been established. There are no other pre-clinical data of relevance.

Chewing gum base

Calcium carbonate

Butylhydroxytoluene

Sorbitol

Maltitol liquid

Glycerol

Acesulfame potassium

Flavour

Mannitol

Sodium Carbonate, Anhydrous

Sodium Hydrogen Carbonate

Eurolake Quinoline Yellow, E104

Carnauba wax

None known.

24 months.

Do not store above 25ºC. Store in the original package.

NiQuitin 4 mg Mint Gum is available in packages of 12, 24, 36 and 96 gums.

Gums are packed 12 to a blister strip in 3 rows of 4 gums. The blister is partperforated, splitting the blister into 2 sections of 6 gum pieces each.

None.

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford TW8 9GS, UK.

PL 00079/0377

07 February 2002

30/09/2010