Nicorette Freshmint 2mg Gum

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NICOTINE

Available from:

McNeil Products Limited

ATC code:

N07BA01

INN (International Name):

NICOTINE

Pharmaceutical form:

MEDICATED CHEWING-GUM

Composition:

NICOTINE 2 milligram(s)

Prescription type:

OTC

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2006-08-30

Patient Information leaflet

Reference: 100902
Version: MAN-K
Date: 2015
Dimensions: 280x180 mm
FRESHMINT 2 MG AND 4 MG GUM
NICOTINE CHEWING GUM
WHAT YOU SHOULD KNOW ABOUT
NICORETTE
® FRESHMINT 2 MG GUM
(2 mg nicotine chewing gum)
NICORETTE
® FRESHMINT 4 MG GUM
(4 mg nicotine chewing gum)
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 THE MEDICINE IS FOR
NICORETTE
®
gum 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.
NICORETTE
®
gum can also be used when you are
pregnant or breast-feeding to help you stop
smoking, as the risks to your baby are far less than
if you continue to smoke. For more information,
see ’’_If you are pregnant or breast-feeding_’’ section.
Ideally you should always aim to stop smoking.
You can use NICORETTE
®
gum to achieve this by
using it to completely replace all your cigarettes.
However NICORETTE
®
gum 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 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. Details of NICORETTE
®
ACTIvESTOP
®
are at
the end of this leaflet.
If you smoke 20 or fewer cigarettes a day, the
2 mg nicotine gum will help relieve your cravings.
If you smoke more than 20 cigarettes a d

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorette Freshmint 2mg Gum or NicAssist Minty Fresh 2 mg Gum
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chewing Gum containing 2mg nicotine, as nicotine resinate.
For excipients see section 6.1
3
PHARMACEUTICAL FORM
Medicated Chewing Gum
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorette Freshmint 2 mg Gum 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 Freshmint 2 mg Gum 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 Freshmint 2 mg Gum should be chewed slowly according to the
instructions.
The strength of gum to be used will depend on the smoking habits of
the
individual. In general, if the patient smokes 20 or less cigarettes a
day, 2mg
nicotine gum is indicated. If more than 20 cigarettes per day are
smoked, 4mg
nicotine gum will be needed to meet the withdrawal of the high serum
nicotine
levels from heavy smoking.
Nicorette Freshmint 2mg Gum 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 Gum and as soon as they are able, reduce
the
number of gums used until they have stopped completely.
Smokers aiming to reduce cigarettes should use Nicorette Freshmint 2
mg
Gum, as needed, between smoking episodes to prolong smoke-free
intervals
and with the intention to reduce smoking as much as possible.
Page 2 of 9
As soon as they are ready smokers should aim to quit smoking
completely.
Maximum daily dose: 15 pieces per day.
When making a quit attempt behavioural therapy, adv