Nicorette QuickMist Freshmint 1mgspray Mouthspray

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

Nicotine

Dostępny od:

JNTL (MALAYSIA) SDN. BHD.

INN (International Nazwa):

Nicotine

Sztuk w opakowaniu:

13.2 ml

Wyprodukowano przez:

McNeil AB

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NICORETTE
®
QUICKMIST MOUTHSPRAY
Nicotine (1mg/spray)
1
WHAT IS IN THIS LEAFLET
1.
What Nicorette
®
QuickMist is
used for
2.
How Nicorette
®
QuickMist works
3.
Before you use
Nicorette
®
QuickMist
4.
How to use Nicorette
®
QuickMist
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Nicorette
®
QuickMist
8.
Product Description
9.
Manufacturer and
Product Registration
Holder
10.
Date of revision
WHAT NICORETTE
®
QUICKMIST IS USED
FOR
Nicorette
®
QuickMist is used to help you
stop smoking when you want to quit. This is
a type of treatment called Nicotine
Replacement Therapy (NRT).
HOW NICORETTE
®
QUICKMIST WORKS
Nicorette
®
QuickMist will give you fast
relief of your cravings for nicotine and the
withdrawal symptoms you get when
stopping smoking. When you suddenly
stop providing nicotine from tobacco to
your body, you get hit by different kinds of
unpleasant feelings called withdrawal
symptoms.
By using Nicorette
®
QuickMist you can
prevent or reduce these unpleasant feelings
and cravings for smoking. This is because
you continue to provide a small amount of
nicotine to your body for a short of time.
Using Nicorette
®
QuickMist does not
involve the health dangers of tobacco
smoking. This is because it does not
contain the tar, carbon monoxide or other
toxins in cigarette smoke.
To improve the chances of helping you to
stop smoking, you should also seek
counselling advice and support, if you can.
BEFORE YOU USE NICORETTE
®
QUICKMIST
_-When you must not use it _
If you are allergic (hypersensitive) to
nicotine or any of the other ingredients in the
mouth spray.
_-Before you start use it_
Contact your doctor if you suffer from the
following. You may be able to have
Nicorette
®
QuickMist, but need to discuss
with you doctor first if you have:
-
Recently (within 3 months) had a
heart attack or stroke
-
Chest pain (unstable angina), or
resting angina
-
A heart condition that effects your
heart rate or rhythm
-
High blood pressure which is

Charakterystyka produktu

FOR HEALTHCARE PROFESSIONALS USE ONLY
NAME OF THE PRODUCT
Nicorette® QuickMist 1mg/Spray, Mouthspray (Freshmint)
ACTIVE INGREDIENT
Nicotine 1mg/spray
QUALITATIVE AND QUANTITATIVE COMPOSITION
One spray delivers 1mg nicotine in 0.07ml solution. 1ml solution
contains 13.6mg nicotine.
Excipient with known effect:
Ethanol 7.1mg/spray or 9.7 % w/v
Propylene glycol 11mg/spray
Butylated hydroxytoluene 363 ng/spray
For the full list of excipients, see information under List of
Excipients
PHARMACEUTICAL FORM
Oromucosal spray, solution
A clear to weakly opalescent, colourless to light yellow solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Nicorette® QuickMist is to be used for the treatment of tobacco
dependence in adults by relief of nicotine
withdrawal symptoms, including cravings, during a quit attempt or to
cut down smoking before stopping
completely. Permanent cessation of tobacco use is the final objective.
Nicorette® QuickMist should
preferably be used in conjunction with a behavioral support program.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Behavioural therapy advice and support will normally improve the
success rate.
_ _
_Adults and Elderly _
Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing
episode and do not exceed 64
sprays (4 sprays per hour, over 16 hours) in any 24-hour period.
_ _
_Abrupt Smoking Cessation _
For smokers willing and ready to stop smoking immediately.
Subjects should stop smoking completely during the course of treatment
with Nicorette® QuickMist.
The following chart lists the recommended usage schedule for the
oromucosal spray during full treatment
(Step I) and during tapering (Step II and Step III).
Example: If an average of 15 cigarettes per day are usually smoked,
1-2 sprays should be used at least 15
times during the day.
To help stay smoke free after Step III, subjects may continue to use
the oromucosal spray in situations
when they are strongly tempted to smoke. One spray may be used in
situations where there is an urge to
smoke, with a second spray