Nicorette Inhaler

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nicotine 10mg;  

Available from:

Johnson & Johnson (New Zealand) Limited

INN (International Name):

Nicotine 10 mg

Dosage:

10 mg

Pharmaceutical form:

Volatile liquid for inhalation

Composition:

Active: Nicotine 10mg   Excipient: Levomenthol Nitrogen

Units in package:

Aluminium foil, starter pack (not marketed), 6 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Pfizer Cork Limited

Product summary:

Package - Contents - Shelf Life: Aluminium foil, starter pack - 6 dose units - 36 months from date of manufacture stored at or below 25°C - Aluminium foil, 1x18 - 18 dose units - 36 months from date of manufacture stored at or below 25°C - Aluminium foil, 1x42 - 42 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1994-07-20

Patient Information leaflet

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
NICORETTE
®
 Inhaler
Nicotine
10 mg (4 mg delivered), inhalation
What is in this leaflet
This leaflet answers some common questions about Nicorette Inhaler. It does not contain all the
available information or take the place of professional advice such as talking to your doctor or
pharmacist.
All medicines have risks and benefits. You need to weigh the risks of using Nicorette Inhaler against the
benefits it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this
leaflet with the medicine. You may need to read it again.
What Nicorette Inhaler is used for
Nicorette Inhaler helps you to give up smoking by relieving the desire to smoke, as well as some of the
unpleasant effects, which smokers experience when they stop smoking.
Nicorette Inhaler is also used to help smokers who need to temporarily stop smoking e.g. on long air
flights. Nicorette Inhaler can also help reduce the amount of cigarettes smoked in smokers who are
unable or unwilling to quit.
How Nicorette Inhaler works
Smokers have both a physical reliance on nicotine (i.e. the body becomes dependent on nicotine) and a
psychological reliance on the smoking habit.
When you give up smoking, your body will miss the effects of nicotine and you will miss the habit of
smoking.
Nicorette Inhaler helps you to tackle these two sides of the problem separately, instead of all at once.
It is your body's dependence on nicotine, which causes withdrawal symptoms when you suddenly stop
smoking. Nicotine is an addictive substance. Symptoms may include irritability, restlessness, depression,
we

Summary of Product characteristics

Page 1 of 12 
DATA SHEET 
NICORETTE
®
 INHALER 
_NICOTINE 10 MG _
PRESENTATION 
Nicotine for inhalation. 
Excipients: Levomenthol and porous plug. 
USES 
_ACTIONS _
Pharmocotherapeutic group: ATC code: N07B A01. 
Abrupt cessation of the use of tobacco-containing products following
a 
prolonged period of daily use results in a characteristic withdrawal
syndrome 
that includes four or more of the following: dysphoria or depressed
mood; 
insomnia; irritability; frustration or anger; anxiety; difficulty
concentrating; 
restlessness or impatience; decreased heart rate; and increased
appetite or 
weight gain. Nicotine craving, which is recognised as a clinically
relevant 
symptom, is also an important element in nicotine withdrawal. 
Clinical studies have shown that nicotine replacement products can
help 
smokers abstain from smoking. 
_PHARMACOKINETICS _
PHARMACOKINETIC PROPERTIES OF NICORETTE
®
 INHALER 
The major fraction of the nicotine in NICORETTE
®
  Inhaler is deposited in the 
oral cavity. Continuous, rapid inhalations over 20 minutes release up
to about 
4mg of the nicotine from each cartridge and about 50% of the
released 
nicotine is systemically available, i.e about 2mg. Absorption of
nicotine 
through the buccal mucosa is slow and does not produce the high and
rapid 
nicotine plasma concentrations seen with cigarette smoking. Self-
administration (ad lib. at clinical use) typically produces nicotine
plasma levels 
of 6-8ng/ml, which are only about 1/3 of those achieved with
cigarette 
smoking. The plasma levels following clinical use correspond to once
hourly 
chewing of NICORETTE
®
  chewing gum 2mg and once hourly use of 
NICORETTE
®
  Nasal Spray. Maximal plasma concentrations are reached 
within 15 minutes after the end of inhalation. 
Steady state plasma levels of approximately 20ng/ml are achieved
with 
continuous, rapid inhalations during 20 minutes per hour, 1 fresh
cartridge 
Page 2 of 12 
each hour, for 11 hours at ambient room temp