NICABATE CLEAR PATCH nicotine 14mg/24 hours transdermal drug delivery system sachet

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

nicotine, Quantity: 78 mg (Equivalent: nicotine, Qty 14 mg/24 h)

Fáanlegur frá:

Haleon Australia Pty Ltd

Lyfjaform:

Drug delivery system, transdermal

Samsetning:

Excipient Ingredients: ethylene dioleamide; polyethylene; ethylene/vinyl acetate copolymer; polyisobutylene; titanium dioxide; ethyl acetate; ethanol; isopropyl alcohol; methoxyisopropanol; ethylcellulose; pyroxylin

Stjórnsýsluleið:

Transdermal

Einingar í pakka:

1 pouch, 7 pouches, 3 pouches, 14 pouches

Gerð lyfseðils:

Not scheduled. Not considered by committee

Ábendingar:

For the treatment of nicotine dependence as an aid to smoking cessation.

Vörulýsing:

Visual Identification: 'Clear patch with marking "NCQ 14"'; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2001-12-07

Upplýsingar fylgiseðill

*Nicabate P is only available on the PBS
PC1007113
1
NICABATE AND NICABATE P
TRANSDERMAL PATCH
7 MG/24 HOUR, 14 MG/24 HOUR AND 21 MG/24 HOUR NICOTINE
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE. _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NICABATE
Patches. It does not contain all the
available information.
It does not take the place of talking
to your pharmacist or doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you using
NICABATE Patches against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ARE NICABATE
PATCHES USED FOR?
NICABATE Patches *are tan or
clear square patches for sticking on
your skin. They are a stop smoking
aid which helps you to give up
smoking by replacing some of the
nicotine you are used to getting from
cigarettes. It is the nicotine in
cigarettes that can make you
physically addicted to them. This
type of treatment is called Nicotine
Replacement Therapy (NRT).
NICABATE Patches provide a
steady amount of nicotine to your
body, generally at a level lower than
from cigarettes. This nicotine
relieves some of the unpleasant
symptoms such as feeling ill or
irritable that smokers often feel when
they try to give up. The nicotine can
also reduce your cravings for a
cigarette and help you to resist the
urge to smoke.
Because NICABATE Patches do not
contain the tar, carbon monoxide or
other toxins in cigarette smoke, they
do not have the health dangers of
tobacco.
If possible, when giving up smoking,
NICABATE Patches should be used
with a stop smoking behavioural
support programme.
There are no health benefits to
smoking. It is always better to give
up smoking and using NRT can help.
In general, any possible side effects
associated with NRT are far
outweighed by the well established
dangers of continuing to smoke.
Your

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION
NICABATE CLEAR PATCH, NICABATE PRE-QUIT AND NICABATE
P
RATE CONTROLLED NICOTINE TRANSDERMAL
PATCHES
1
NAME OF THE MEDICINE
Nicotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Nicotine
is
S-3-(1-methyl-2-pyrrolidinyl)-pyridine
and
is
the
major
pharmacologically active alkaloid of tobacco.
Dose
Absorbed in
24 Hours
(mg/day)
System
Area
(cm
2
)
Total
Nicotine
Content:
(mg)
21
14
7
22
15
7
114
78
36
Nicotine is the active ingredient; other components of the system are
pharmacologically inactive.
The Nicabate Pre-Quit patch has the same formulation as the Nicabate
Clear Patch 21 mg/24 hour
patch.
*Nicabate P transdermal nicotine patch is only available in 21mg
patches.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
The free alkaloid is absorbed rapidly through the skin and respiratory
tract.
The rate of delivery of nicotine to the patient from each system (40
mcg/cm
2
- h)
is
proportional to
the
surface area. About 73% of
the
total amount of nicotine remains
in the system 24 hours
after application. Nicabate* is labelled by the dose actually absorbed
by the patient (i.e. 7 mg/d, 14
mg/d or 21 mg/d).
The dose of nicotine absorbed from Nicabate represents 68% of the
amount
released in 24 hours. The other 32% evaporates from the edge of the
system.
Nicabate is a multilayered rectangular film containing nicotine as the
active agent. For the three
doses the composition per unit area is identical. Proceeding from the
visible surface toward the
surface attached to the skin are: (1) an occlusive backing consisting
of polyethylene / aluminium /
polyethylene terephthalate/ ethylene-vinyl acetate
copolymer; for Nicabate and Nicabate P and
polyethylene terephthalate / ethylene-vinyl acetate copolymer for
Nicabate Clear Patch; (2) a drug
reservoir containing nicotine (in an ethylene-vinyl acetate copolymer
matrix containing ethylene
dioleamide as slip agent): (3) a rate-controlling membrane
(polyethylene); (4) a polyisobutylene
2
adhes