Nicotrol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nicotine 8.3mg (as a 10cm² patch delivering 5mg/16hours);  

Available from:

Johnson & Johnson (New Zealand) Limited

INN (International Name):

Nicotine 8.3 mg (as a 10cm² patch delivering 5mg/16hours)

Dosage:

0.31 mg/h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Nicotine 8.3mg (as a 10cm² patch delivering 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:

2001-07-17

Patient Information leaflet

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
NICOTROL
®
 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 Nicotrol 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 Nicotrol 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 Nicotrol Patch is used for
Nicotrol 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 Nicotrol 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.
Nicotrol 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.
Nicotrol Patch is intended to ease such withdrawal symptoms by providing your body with nicotine.
This leaves your mind free to concentrate on overc

Summary of Product characteristics

DATA SHEET 
NICOTROL
®
 PATCH 
_5MG/16H, 10MG/16H, 15MG/16H _
PRESENTATION 
Nicotrol Patch is a transdermal delivery system for
topical application, available in sizes 
of 30, 20 and 10 cm² each containing 0.83 mg/cm² 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 eliminating organ 
is the liver,�