Nicorette 15mg Inhalator

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

NICOTINE

Beschikbaar vanaf:

McNeil Products Limited

ATC-code:

N07BA01

INN (Algemene Internationale Benaming):

NICOTINE

farmaceutische vorm:

INHALATION POWDER

Samenstelling:

NICOTINE 15 milligram(s)

Prescription-type:

OTC

Therapeutisch gebied:

OTHER NERVOUS SYSTEM DRUGS

Autorisatie-status:

Authorised

Autorisatie datum:

2013-09-27

Bijsluiter

PRODUCT
BRAND
COMPONENT CODE
VERSION
DESIGN
REPLACED COMP CODE
MARKET
DIELINE / TECH DRAWING REFERENCE
COLOR
ADDITIONAL
INFORMATION
CH020025
560x180mm
GB
651379
651536
Inhaler 15mg Leaflet
NICORETTE
SPRUCE
LKL-g
9 pt
BLACK
PMS 355
PDD McNeil, HBG, SWE June 30, 2017 08:41:46
Brand: Nicorette
Product:
Inhaler 15mg Leaflet
Component code:
651536
Version number: LKL-g
15MG INHALATOR
NICOTINE
INHALATION CARTRIDGES
WHAT SHOULD YOU KNOW ABOUT
NICORETTE
® 15MG INHALATOR
(nicotine 15 mg per cartridge)
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
®
inhalator 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
®
inhalator to achieve this by using it to
completely replace all your cigarettes.
However NICORETTE
®
inhalator can also be used in other
ways,
n 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,
n at those times when you can’t or 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
® INHALATOR DO?
When you stop smoking or cut down the number of
cigarettes you smoke, your body misses the nicotine that you
have been absorbing. You may experience unpleasant
feelings and a strong d

Productkenmerken

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorette

15mg Inhalator
/ Boots NicAssist 15 mg Inhalator.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine 15mg per cartridge.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Inhalation cartridge for oromucosal use.
A white to slightly coloured porous plug in a sealed, transparent
plastic tube.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorette Inhalator 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 Inhalator is indicated in pregnant and lactating women
making a quit
attempt.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and Children over 12 years of age _
Nicorette Inhalator should be used whenever the urge to smoke is felt
or to
prevent cravings in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially
replace
all their cigarettes with the Inhalator and as soon as they are able,
reduce the
number of cartridges used until they have stopped completely.
Smokers aiming to reduce cigarettes should use the Inhalator, as
needed,
between smoking episodes to prolong smoke-free intervals and with the
intention to reduce smoking as much as possible.
As soon as they are ready smokers should aim to quit smoking
completely.
Maximum daily dose: 6 cartridges.
Page 2 of 9
When making a quit attempt behavioural therapy, advice and support
will
normally improve the success rate. Those who have quit smoking, but
are
having difficulty discontinuing their Inhalator are recommended to
contact
their pharmacist or doctor for advice.
Each cartridge can be used for approximately eight 5-minute sessions,
with
each cartridge lasting approximately 40 minutes of intense use. The
more the
subject