Nicorette QuickMist 1mg/spray mouthspray

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NICOTINE

Available from:

McNeil Products Limited

ATC code:

N07BA01

INN (International Name):

NICOTINE

Pharmaceutical form:

OROMUCOSAL SPRAY

Composition:

NICOTINE 1 milligram(s)/dose

Prescription type:

OTC

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2012-12-03

Patient Information leaflet

PRODUCT
BRAND
COMPONENT CODE
VERSION
DESIGN
REPLACED COMP CODE
MARKET
DIELINE / TECH DRAWING REFERENCE
COLOR
ADDITIONAL
INFORMATION
CH020038
558x179mm
GB
651540
651766
Ons 1mg Mint Leaflet
NICORETTE
SPRUCE
MPS-c
10 pt
BLACK
PMS 355
J&J AD, HBG, SWE August 9, 2018 12:49:54
651540
b
b
c
e
e
f
a
d
TO LOCK NOZZLE
QUICKMIST 1MG/SPRAY MOUTHSPRAY
NICOTINE
WHAT SHOULD YOU KNOW ABOUT
NICORETTE
® QUICKMIST MOUTHSPRAY
(nicotine 1 mg per spray)
Please read this leaflet carefully
before you start using this medicine. It
provides useful information on how to
use it safely. Keep the leaflet, you might
need it again.
If you think you are having side-effects,
have any questions or are not sure about
anything please ask your doctor, nurse
or pharmacist.
1 WHAT THIS MEDICINE IS FOR
NICORETTE
®
QuickMist is a nicotine
replacement therapy (NRT). It is used
to relieve and /or prevent withdrawal
symptoms and reduce the cravings you
get when you try to stop smoking or
when cutting down the number of
cigarettes you smoke.
Ideally you should always aim to stop
smoking. You can use NICORETTE
®
mouthspray to achieve this by using it to
completely replace all your cigarettes.
However NICORETTE
®
mouthspray can
also be used in other ways,
 if you feel unable to stop smoking
completely, or wish to replace certain
cigarettes and therefore it can help
you to cut down the number of
cigarettes you smoke.
 at those times when you can’t and do
not want to smoke. For example,
- Where you don’t want to smoke and
avoid harm to others e.g children or
family.
- Smoke free areas e.g Pub, work,
public transport e.g aeroplanes.
It may also help increase your motivation
to quit.
When making a quit attempt a
behavioural support programme will
increase your chances of success.
WHAT DOES NICORETTE
®
QUICKMIST DO?
When you stop smoking your body
misses the nicotine that you have been
absorbing. You may experience
unpleasant feelings and a strong desire
to smoke (craving). This indicates that
you were dependent on nicotine.
When you use NICORETTE
�

Summary of Product characteristics

Version No: 9, Draft
SNAS BV 3035
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorette QuickMist 1mg/spray mouthspray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.07 ml contains 1 mg nicotine, corresponding to 1 mg nicotine/spray
dose.
Excipients with known effect:
Ethanol (
contains less than 100 mg of ethanol/spray dose).
Propylene glycol
Butylated hydroxytoluene
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Oromucosal spray.
A clear to weakly opalescent, colourless to light yellow solution with
a scent of
peppermint.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorette QuickMist relieves and/or prevents craving and nicotine
withdrawal
symptoms associated with tobacco dependence. It is indicated to aid
smokers wishing
to quit or reduce prior to quitting, to assist smokers who are
unwilling or unable to
smoke, and as a safer alternative to smoking for smokers and those
around them.
_ _
Nicorette QuickMist is indicated in pregnant and lactating women
making a quit
attempt.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The patient should make every effort to stop smoking completely during
treatment
with Nicorette QuickMist.
Behavioural therapy, advice and support will normally improve the
success rate.
_ _
_Directions for use _
If you are using Nicorette QuickMist for the first time or if you have
not used the
spray for 2 days, you must first prime the spray pump.
Priming
1.
Point the spray safely away from you and any other adults, children or
pets that
are near you.
2.
Press the top of the QuickMist with your index finger 3 times until a
fine spray
appears.
Note: priming reduces the number of sprays you may get from Nicorette
QuickMist.
Version No: 9, Draft
SNAS BV 3035
_ _
After priming, point the spray nozzle as close to the open mouth as
possible. Press
the top of the dispenser and release one spray into your mouth,
avoiding the lips. Do
not inhale while spraying to avoid getting spray down your throat. For
best results, do
not swallow for a few seconds after