Nicorette QuickMist Special Precautions

Nicorette QuickMist should not be used by non-smokers.
The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT).
A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe cardiac arrhythmias, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, the oromucosal spray may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated as reduction in nicotine induced catecholamine release can affect carbohydrate metabolism.
Allergic reactions: Susceptibility to angioedema and urticaria.
Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.
Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions.
Epilepsy and seizures: Caution should be exercised in patients with a history of epilepsy or seizures during introduction of nicotine replacement therapy. Tobacco smoke contains substances - including nicotine - which act on brain receptors, and the changes in intake of these when switching from smoked tobacco to nicotine replacement therapy during quitting may affect seizure threshold.
Transferred dependence: Transferred dependence can occur but is unusual 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 CYP1A2 (and possibly by CYP1A1). 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, tacrine, clozapine and ropinirole.
The plasma concentration of other medicinal products metabolised in part by CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect for these drugs is unknown. Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking.
If symptoms persist or get worse, or if new symptoms occur, stop use and consult a physician.
Excipients: The oromucosal spray contains small amounts of ethanol (alcohol), less than 100 mg per dose (1 or 2 sprays). This medicinal product contains less than 1 mmol sodium (23 mg) per spray, i.e. is essentially 'sodium-free'. This medicine contains 11 mg propylene glycol in each spray which is equivalent to 150 mg/mL. Due to the presence of butylated hydroxytoluene, Nicorette QuickMist may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Care should be taken not to spray the eyes whilst administering the oromucosal spray.
Effects on ability to drive and use machines: Nicorette QuickMist has no or negligible influence on the ability to drive and use machines.
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.
Use in Children: Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children, see information under Overdosage.