Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well established dangers of continued smoking.
Precautions: Users should be informed that if they continue to smoke while using the gums they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.

Cardiovascular disease
In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke.
However dependant smokers currently hospitalised as a result of a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with nonpharmacological interventions (such as counselling). If this fails, Nicotinell 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 nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions
Angioedema and urticaria have been reported.

Gastro-intestinal disease
Swallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal and or hepatic impairment
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 (please see section 4.9). Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of with care.


Pheochromocytoma and uncontrolled hyperthyroidism
Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.

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 catalysed by CYP 1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.

Other warnings
People having problems with the joint of the jawbone and denture wearers may experience difficulty in chewing the gum.
In this case, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy.
Because Nicotinell gum contains sorbitol: Patients with rare hereditary conditions of fructose intolerance should not take this medicine.

Nicotinell 2mg Gum (Fruit) contains sweeteners including Sorbitol (powder) 208.0 mg per gum.
Nicotinell 2mg Gum (Mint) contains sweeteners including Sorbitol (powder) 207.9 mg per gum.

Nicotinell 2 mg Gum contains sodium 11.50 mg per piece of gum.
The gum base contains butylated hydroxyl toluene which may cause local irritation to mucous membranes.

Nicotinell 4mg Gum (Fruit) contains sweeteners including Sorbitol (powder) 192.1 mg per gum.
Nicotinell 4mg Gum (Mint) contains sweeteners including Sorbitol (powder) 192.0 mg per gum.

Nicotinell 4 mg Gum contains sodium 11.52 mg per piece of gum.
The gum base contains butylated hydroxy toluene which may cause local irritation to mucous membranes.

Effects on Driving