Nicorette

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nicotine 8.3mg (10cm² patch delivers 5mg/16hours.);  

Available from:

Johnson & Johnson (New Zealand) Limited

INN (International Name):

Nicotine 8.3 mg (10cm² patch delivers 5mg/16hours.)

Dosage:

5mg/16hours

Pharmaceutical form:

Transdermal patch

Composition:

Active: Nicotine 8.3mg (10cm² patch delivers 5mg/16hours.)  

Units in package:

Individual wrap, 7x10cm� patches, 7 patches

Class:

General sale

Prescription type:

General sale

Manufactured by:

Siegfried Ltd

Product summary:

Package - Contents - Shelf Life: Individual wrap, 7x10cm? patches - 7 patches - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1991-06-28

Patient Information leaflet

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
NICORETTE
®
 Patch
Nicotine
5 mg/16h, 10 mg/16h, 15 mg/16h, transdermal patch
What is in this leaflet
This leaflet answers some common questions about Nicorette Patch. 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 Patch 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 Patch is used for
Nicorette Patch 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.
How Nicorette Patch 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 itself.
When you give up smoking, your body will miss the effects of nicotine and you will miss the habit of
smoking.
Nicorette Patch 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,
weight gain, and craving for cigarettes.
weight gain, and craving for cigarettes.
Nicorette Patch is intended to ease such withdrawal symptoms by providing your body with nicotine.
This leaves your mind free to concentrate o

Summary of Product characteristics

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TOPICS  |  SEARCH 
DATA SHEET 
NICORETTE
®
 PATCH 
5MG/16H, 10MG/16H, 15MG/16H 
PRESENTATION 
Nicorette Patch is a transdermal delivery system for topical
application, 
available in sizes of 30, 20 and 10 cm
2
 each containing 0.83 mg/cm
2
 of 
nicotine, releasing 15 mg, 10 mg and 5 mg respectively over 16 hours.
Each 
patch is rectangular in shape and comprises 3 distinct layers; an
outer beige 
matt finish backing layer, a patterned silvery middle layer and an
inner clear 
release liner, which is removed prior to use. Each patch is packaged
in a heat 
sealed multilaminate sachet. 
USES 
ACTIONS 
Pharmacotherapeutic group: Drug for treatment of addiction. 

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 
GENERAL PHARMACOKINETIC PROPERTIES OF NICOTINE 
The volume of distribution following i.v. administration of nicotine
is about 2 to 
3 L/kg. Plasma protein binding of nicotine is <5%. Therefore, changes
in 
nicotine binding from use of concomitant drugs or alterations of
plasma 
proteins by disease states would not be expected to have significant
effects 
on nicotine kinetics. 

The average plasma clearance following intravenous administration
of 
nicotine is about 70 L/hour and the terminal half-life approximately
2 hours. 
The major eliminat