NICABATE MINI LOZENGES nicotine 1.5 mg Mint Flavour lozenge tube

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

nicotine, Quantity: 1.5 mg

Disponible depuis:

Haleon Australia Pty Ltd

DCI (Dénomination commune internationale):

Nicotine

forme pharmaceutique:

Lozenge

Composition:

Excipient Ingredients: sodium alginate; purified water; magnesium stearate; mannitol; polacrilin; sodium carbonate; acesulfame potassium; xanthan gum; potassium bicarbonate; calcium polycarbophil; Flavour

Mode d'administration:

Buccal

Unités en paquet:

60 + 60, 20, 60, 120, 20 + 20

Type d'ordonnance:

Not scheduled. Not considered by committee, Not Scheduled after consideration by Committee

indications thérapeutiques:

For the relief of nicotine withdrawal symptoms including 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 smoking. It should be used as part of a behavioural support programme.

Descriptif du produit:

Visual Identification: White to off white oval tablet with convex surfaces. One surface bearing a debossed "L" logo.; Container Type: Tube; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2008-11-10

Notice patient

NICABATE MINIS MINT – CONSUMER MEDICINE INFORMATION
PAGE 1 OF 5
_ _
NICABATE
MINIS MINT
_1.5 MG AND 4 MG NICOTINE _
_MINI LOZENGES_
CONSUMER
MEDICINE
INFORMATION
_PLEASE READ THIS INFORMATION _
_BEFORE YOU START TAKING THIS _
_MEDICINE. _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about NICABATE Minis.
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 doctor or pharmacist
has weighed the risks of you using
NICABATE Minis against the
benefits this medicine is expected to
have for you.
If you have any concerns about using
this medicine, ask your pharmacist or
doctor.
KEEP THIS INFORMATION WITH THE
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT ARE NICABATE
MINIS USED FOR?
NICABATE Minis are a stop
smoking aid. They can help you stop
smoking over a few months. You
can also use them to help you stop
smoking more gradually over a
longer period of time.
They help 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 Minis contain a nicotine
resin and, when used, nicotine is
released slowly from the resin and
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. You may feel the
following withdrawal symptoms
when you stop smoking; anger,
irritability, frustration; anxiety;
difficulty concentrating; restlessness;
increased appetite and or weight
gain; insomnia; depression. The
nicotine in NICABATE Minis may
help relieve some or many of these
symptoms.
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
dan

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
NICABATE MINIS MINT (NICOTINE) LOZENGES
1
NAME OF THE MEDICINE
Nicotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
_Nicotine _
Nicotine 1.5 mg lozenge
Nicotine 4 mg lozenge
_Excipients: _For the full list of excipients, see section 6.1 List of
Excipients._ _
3
PHARMACEUTICAL FORM
NICABATE MINIS MINT NICOTINE 1.5 MG LOZENGES
White to off white oval tablet with convex surfaces; one surface
bearing a debossed “L”
logo.
NICABATE MINIS MINT NICOTINE 4 MG LOZENGES
White to off white oval tablet with convex surfaces; one surface
bearing a debossed “F”
logo.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the relief of nicotine withdrawal symptoms including 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 smoking. It should
be used as part of a behavioural support programme.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DIRECTIONS FOR USE
One lozenge should be placed in the mouth and allowed to dissolve.
Periodically, the
lozenge should be moved from one side of the mouth to the other and
repeated, until the
lozenge is completely dissolved (approximately 10 – 13 minutes). The
lozenge should not be
chewed or swallowed whole.
2
Users should not eat or drink while a lozenge is in the mouth.
ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY)
ABRUPT CESSATION OF SMOKING
Nicabate Minis 1.5 mg are suitable for smokers who smoke 20 cigarettes
or less a day.
Nicabate Minis 4 mg are suitable for smokers who smoke more than 20
cigarettes a day.
Users should make every effort to stop smoking completely during
treatment with Nicabate
Minis.
Behavioural therapy, advice and support will normally improve the
success rate.
Users should follow the schedule of treatment below:
TABLE 1
STEP 1
WEEKS 1 TO 6
STEP 2
WEEKS 7 TO 9
STEP 3
WEEKS 10 TO 12
To help stay smoke free
over the next 12 weeks:
take a lozenge in
situations when
strongl