Nicorette Citrus 4mg Gum

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1. Name Of The Medicinal Product

Nicorette® Citrus 4 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4 mg nicotine

3. Pharmaceutical Form

Chewing Gum

4. Clinical Particulars 4.1 Therapeutic Indications

Nicorette Citrus 4 mg Gum is for the relief of nicotine withdrawal symptoms as an aid to smoking cessation.

4.2 Posology And Method Of Administration

Nicorette Citrus 4 mg Gum should be chewed slowly according to the instructions.

Adults

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.

• Smoking should be stopped completely.

• Nicorette Citrus 4 mg 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 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. Any spare gum should be retained, as craving may suddenly return.

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

Children

Not for use by persons under age 18 except on the advice of a doctor.

4.3 Contraindications

Nicotine in any form is contra-indicated in pregnancy and lactation (see section 4.6).

4.4 Special Warnings And Precautions For Use

Smokers who wear dentures may experience difficulty in chewing Nicorette Citrus 4 mg Gum.

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

Swallowed nicotine may exacerbate symptoms in patients suffering from gastritis or peptic ulcers.

Allergic reactions such as angioedema and urticaria and ulcerative stomatitis have been reported.

The cardiovascular effects of nicotine may be deleterious to patients with a history of cardiovascular disease (especially angina, cardiac arrhythmias or a myocardial infarction within the last 3 months). Nicorette Citrus 4 mg Gum presents a lesser hazard, however, than smoking, which introduces carbon monoxide as an additional toxic factor.

Nicotine gum should be used with caution in patients with diabetes mellitus, hyperthyroidism or pheochromocytoma, since nicotine causes the release of catecholamines from the adrenal medulla.

The label will state 'Not for use by persons under age 18 except on the advice of a doctor.'

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Nicorette crosses the placenta and is excreted in breast milk; thus it may be a hazard to the foetus or infant.

Patients should be advised to give up smoking without the use of nicotine replacement therapy. Should this fail medical assessment of the risk/benefit ratio of nicotine gum use should be made

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Nicorette Citrus 4 mg Gum in the recommended dose has not been found to cause any serious adverse effects. 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.

Excessive consumption of Nicorette Citrus 4 mg Gum by patients who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches (as may be experienced by such a patient if tobacco is inhaled).

Common

(>1/100)

CNS:

Dizziness, headache

Gastro-intestinal:

Nausea, gastro-intestinal discomfort, hiccups

 

Local:

Sore mouth or throat. Jaw muscle ache. The gum may stick to, and may, in rare cases damage dentures

 

Uncommon

(1/100-1/1000)

Circulatory:

Palpitation

Dermatological:

Erythema, urticaria

 

Local:

Stomatitis

 

Rare

(<1/1000)

Cardiovascular:

Atrial fibrillation

Other:

Allergic reactions such as angioedema

 

Some 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.

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.

4.9 Overdose

Overdosage may occur if many gums are taken simultaneously or in rapid succession. The consequences of an overdose are most likely to be minimised by the early nausea and vomiting known to occur with excessive nicotine intake. Nicotine is also subject to a significant first-pass metabolism.

Symptoms of overdosage are those of acute nicotine poisoning and 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. The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60 mg.

Management of an overdose

All nicotine intake should cease immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Citrus 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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chewing gum base

Xylitol

Sodium carbonate, anhydrous

Blood orange flavour

Magnesium oxide, light

Quinoline yellow (E104)

Talcum

Nitrogen, food grade

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 30oC

6.5 Nature And Contents Of Container

Blister packed strips each containing 15 pieces supplied in packs of 15, 30 and 105 pieces. Pack containing blister strip of 6 pieces

6.6 Special Precautions For Disposal And Other Handling

See section 4.2

7. Marketing Authorisation Holder

Pharmacia Limited.

Davy Avenue

Milton Keynes

MK5 8PH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00032/0295

9. Date Of First Authorisation/Renewal Of The Authorisation

1 May 2001 / 1st January 2002

10. Date Of Revision Of The Text

8 March 2002

Legal Category

GSL.

Nicorette Citrus 4mg Gum

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