NICABATE GUM nicotine 4 mg Extra Fresh Mint Flavour coated chewing gum blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

nicotine polacrilex, Quantity: 28.4 mg

Disponibbli minn:

Haleon Australia Pty Ltd

INN (Isem Internazzjonali):

Nicotine polacrilex

Għamla farmaċewtika:

Gum, chewing

Kompożizzjoni:

Excipient Ingredients: glycerol; xylitol; menthol; Acacia; sorbitol; mannitol; titanium dioxide; acesulfame potassium; purified talc; sodium carbonate; Carnauba Wax; calcium carbonate; sucralose; Flavour; butylated hydroxytoluene; polyvinyl acetate; glycerol ester of partially hydrogenated gum rosin; microcrystalline wax; polyisobutylene; synthetic terpene resin; hydrogenated vegetable oil; mono- and di- glycerides

Rotta amministrattiva:

Buccal

Unitajiet fil-pakkett:

100 + 30, 100, 200 + 100, 30, 24, 30 + 30, 250, 200, 300

Tip ta 'preskrizzjoni:

Not scheduled. Not considered by committee

Indikazzjonijiet terapewtiċi:

Relief of nicotine withdrawal symptoms including cravings associated with smoke cessation. Nicabate Coated Gum Extra Mint may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping completely.

Sommarju tal-prodott:

Visual Identification: Rectangular, white/off-white coat; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2015-08-28

Fuljett ta 'informazzjoni

NICABATE GUM – CONSUMER MEDICINE INFORMATION
PAGE 1 OF 6
NICABATE GUM
_2 MG AND 4 MG 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 Gum. 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 Gum
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 IS NICABATE
GUM USED FOR?
NICABATE Gum is a mint
flavoured stop smoking aid. It
can help you stop smoking over a
few months. You can also use it
to help you stop smoking more
gradually over a longer period of
time.
It helps you 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).
It contains a nicotine resin.
When it is chewed, nicotine is
released slowly from the resin
and is absorbed through the
lining of the mouth.
This medicine can reduce your
urge to smoke by providing some
of the nicotine previously inhaled
from cigarettes and helps you
resist cigarettes. This nicotine
also relieves many of the
withdrawal symptoms such as
feeling ill or irritable and
cravings that you may feel when
you try to give up.
NICABATE Gum does not have
the health dangers of tobacco
because it does not contain the
tar, carbon monoxide or other
toxins present in cigarette smoke.
If possible, when giving up
smoking, NICABATE Gum
should be used with a stop
smoking behavioural support
programme.
NICABATE 2 mg Gum is
suitable for smokers who smoke
less than 20 cigarettes a day.
NICABATE 4 mg Gum is
suitable for smokers who smoke
more than 2

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION
NICABATE GUM (NICOTINE) CHEWING GUM
1
NAME OF THE MEDICINE
Nicotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
_Nicotine _
Nicotine is 3-[(2S)-1-methylpyrolidin-2-yl]pyridine and is the major
pharmacologically active
alkaloid of tobacco. The free alkaloid is absorbed rapidly through the
skin and respiratory
tract.
Nicotine 2 mg coated chewing gum
Nicotine 4 mg coated chewing gum
_Excipients: _For the full list of excipients, see section 6.1 List of
Excipients._ _
3
PHARMACEUTICAL FORM
Off-white rectangular pillow-shaped coated chewing gum and is
approximately 20 x 12 mm.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the relief of nicotine withdrawal symptoms including nicotine
cravings associated with smoking
cessation. It may also be used as part of a smoking reduction strategy
by smokers who are unable or
not ready to stop smoking abruptly as a step towards stopping
completely. If possible, when
stopping smoking, it should be used in conjunction with a behavioural
support programme as this
normally improves the success rate.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY)
Nicabate gum 2 mg is suitable for smokers who smoke fewer than 20
cigarettes a day.
Nicabate gum 4 mg is suitable for smokers who smoke more than 20
cigarettes a day.
Users should make every effort to stop smoking completely during
treatment with Nicabate
gum.
Behavioural therapy, advice and support will normally improve the
success rate.
2
Nicabate gums should be chewed as directed whenever there is an urge
to smoke, to
maintain complete abstinence from smoking.
Users should follow the schedule of treatment in Table 1 below:
TABLE 1
STEP 1
STEP 2
STEP 3
Initial treatment
period.
12 weeks
Step down
treatment
period.
2 weeks
Step off
treatment
period
2 weeks
Chew 1 piece
whenever there is
an urge to smoke.
Use 8 – 12
pieces/day of the
2 mg strength or
8-10 pieces/day
of the 4 mg
strength.
Gradually
reduce gum use
to 4 - 6
pieces/day.
Use 1