McNeil Healthcare (Ireland) Ltd

Nicorette Icy White 2mg Medicated Chewing Gum

Each medicated chewing gum contains 2 mg nicotine as a resin complex.

For a full list of excipients, see section 6.1.

Medicated Chewing Gum.

A square, coated, white coloured chewing gum

For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms:

- thereby facilitating smoking cessation in smokers motivated to quit.

- helping smokers temporarily abstain from smoking

In smokers currently unable or not ready to stop smoking abruptly, Nicorette gum may also be used as part of a programme to reduce smoking prior to stopping completely.

Nicorette Icy White 2mg Gum should be chewed slowly.

Smoking cessation

Adults

The strength of gum to be used will depend on the smoking habit of the individual. In general, if the patient smokes fewer than 20 cigarettes a day, Nicorette Icy White 2mg Gum is indicated. If more than 20 cigarettes per day are smoked Nicorette Icy White 4mg Gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. The patient should be urged to stop smoking completely when initiating therapy with Nicorette Icy White Gum.

The chewing gum 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 that 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.

Nicorette Icy White 2mg Gum may be used for up to 3 months during which time the habits associated with smoking will be lost. For those using the 4mg Gum, the 2mg will be helpful during withdrawal.

If not successful after 12 weeks the patient should be encouraged to make a fresh attempt to stop smoking. This may necessitate full or partial re-treatment with an NRT programme.

Temporary Abstinence

During periods of temporary abstinence, the patient should use Nicorette Icy White Gum when required to relieve nicotine cravings and withdrawal symptoms.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes fewer than 20 cigarettes a day, Nicorette Icy White 2mg Gum is indicated. If more that 20 per day are smoked Nicorette Icy White 4mg Gum is indicated.

Not more than 15 pieces of the gum should be used per day.

Smoking reduction

For smokers who are unwilling or unable to quit abruptly.

Use the 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 is variable and depends on the patients needs. Not more than 15 pieces of the gum should be used per day.

If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.

Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the number of cigarettes has been reduced to a level whereby the smoker feels ready to quit completely, then start as outlined for “smoking cessation” as given above.

If the 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.

A minor reduction in total clearance of nicotine has been demonstrated in healthy elderly patients, however, not justifying adjustment of dosage.

● Use in non-smokers

● Use in persons hypersensitive to nicotine or any ingredient in Nicorette Icy White Gum.

Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette Icy White Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence.

Nicorette should be used with caution in patients with cardiovascular disease, severe/moderate hepatic impairment, severe renal impairment, active and duodenal ulcers.

Nicotine, both from NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette should be used with caution in patients with hyperthyroidism or pheochromocytoma.

Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation.

Smokers who wear dentures may experience difficulties in chewing Nicorette Icy White Gum.

Smoking (but not nicotine) is associated with an increase in CYP1A2 activity. After cessation of smoking, reduced clearance of substrates for this enzyme may occur. This may lead to an increase in plasma levels for some medicinal products of potential clinical importance and for products with a narrow therapeutic window, e.g. theophylline, tacrine and clozapine.

The plasma concentration of other drugs metabolised in part by CYP1A2 e.g. imipramine, olanzapin, clonipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect is unknown.

Limited data indicate the metabolism of flecainide and pentazocine may also be induced by smoking

Pregnancy:

Nicotine passes freely to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent.

Therefore, the pregnant smoker should always be advised to stop smoking completely without the use of nicotine replacement therapy. The risk of continued smoking may pose a greater hazard to the foetus as compared with the use of nicotine replacement therapy products in a supervised cessation programme. Use of Nicorette Icy White Gum should only be initiated after advice from a physician.

Lactation:

Nicotine passes freely into breast milk in quantities that may affect the child even in therapeutic dose. Nicorette Icy White Gum should therefore not be used during breast-feeding.

Not applicable

Nicorette Icy White Gum may cause adverse reactions similar to those associated with nicotine administered by other means and are dose dependent.

Symptoms such as dizziness, headache and sleeplessness may be related to withdrawal symptoms associated with smoking cessation. Increased incidence of aphthous ulcer may occur after smoking cessation. The causality is unclear.

Excessive use of nicotine from either NRT and/or smoking might cause symptoms of an overdose. Symptoms of an overdose are those of acute nicotine poisoning and include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and general convulsions.

Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal.

Management of overdose:

The administration of nicotine must be stopped immediately and the patient should be treated symptomatically. Tachycardia causing circulatory impairment may require treatment with a β-blocker. Excitation and convulsions may be treated with diazepam. Mechanically assisted ventilation should be instituted if necessary.

Pharmacotherapeutic Group: Drug for treatment of addiction

ATC Code: NO7B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Icy White 2mg Gum are comparatively small. The response at any one time represents a summation of stimulation 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.

The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Clinical studies have shown that the gum helps to improve tooth whiteness.

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 proportioned to the amount of nicotine chewed and are unlikely to exceed those obtained from smoking cigarettes.

There are no 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

Chewing gum base*

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Sodium hydrogen carbonate

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Talc

Sub coating

Winterfresh

Hypromellose

Sucralose

Polysorbate 80

Purified water

Hard Coating

Xylitol

Pre-gelatinised starch

Titanium dioxide (E171)

Winterfresh

Carnauba wax

Purified water

*Chewing gum base contains:

Calcium carbonate

Ester gums

Microcrystalline

Isobutylene-Isoprene copolymer (butyl rubber)

Glycerol monostearate

Polyethylene

Polyvinyl acetate

Polyisobutylene

Butylhydroxytoluene (BHT E321)

Not applicable

3 years

Do not store above 25°C.

PVC/PVDC/Al Blister packed strips each containing 6,10 or 15 pieces supplied in packs of 10, 12, 15, 30, 105 and 210 pieces.

Not all pack sizes may be marketed.

No Special Requirements

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

823/49/24

Date of first authorisation: 6^th August 2010

January 2012