Nicorette Quickmist 1mg-spray mouthspray

Nicorette QuickMist 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.

Nicorette QuickMist is indicated in pregnant and lactating women making a quit attempt.

Directions for use

If you are using Nicorette QuickMist for the first time or if you have not used the spray for 2 days, you must first prime the spray pump.

Priming

1. Point the spray safely away from you and any other adults, children or pets that are near you.

2. Press the top of the QuickMist with your index finger 3 times until a fine spray appears.

Note: priming reduces the number of sprays you may get from Nicorette QuickMist.

After priming, point the spray nozzle as close to the open mouth as possible. Press the top of the dispenser and release one spray into your mouth, avoiding the lips. Do not inhale while spraying to avoid getting spray down your throat. For best results, do not swallow for a few seconds after spraying.

The patient should not eat or drink when administering the oromucosal spray.

Care should be taken not to spray the eyes whilst administering the mouth spray.

Adults and Children over 12 years of age

Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays.

Most smokers will require 1-2 sprays every 30 minutes to 1 hour.

You may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period.

Each mouthspray contains at least 150 sprays.

Each 0.07 ml spray  contains 1 mg nicotine, corresponding to 1 mg nicotine/spray dose.

Excipient: ethanol (contains less than 100 mg of ethanol/spray dose).

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette QuickMist presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe dysrhythmia or cerebrovascular accident and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette QuickMist 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 NRT is initiated.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions.

Renal or hepatic impairment: Nicorette QuickMist 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. Products containing nicotine should not be left where they may be misused, handled or ingested by children. See Section 4.9 Overdose.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette QuickMist should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

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 metabolised by CYP 1A2 (and possibly by CYP 1A1). 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, clozapine and ropinirole.

Excipients: The mouthspray contains small amounts of ethanol (alcohol), less than 100 mg per spray.