Nicorette invisi 10mg patch / NicAssist Translucent 10mg Patch

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NICOTINE

Available from:

McNeil Products Limited

ATC code:

N07BA01

INN (International Name):

NICOTINE

Pharmaceutical form:

TRANSDERMAL PATCH

Composition:

NICOTINE 10 milligram(s)

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
130x700
GB
6511558
6511721
Invisipatch Leaflet
NICORETTE
SPRUCE
LKL-h
9 pt
BLACK
PMS 355
PDD McNeil, HBG, SWE June 9, 2017 12:06:42
Brand: Nicorette
Product: Invisipatch leaflet
Component code: 6511721
Version number: LKL-h
Dimension: 130 x 700mm
Text font: 9 pt
INVISI PATCH
NICOTINE
TRANSDERMAL PATCH
WHAT SHOULD YOU KNOW ABOUT
NICORETTE
®
INVISI 25 MG
PATCH
STEP 1
NICORETTE
®
INVISI 15 MG
PATCH
STEP 2
NICORETTE
®
INVISI 10 MG
PATCH
STEP 3
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
®
invisi patch 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
®
invisi patch to achieve this by using it to
completely replace all your cigarettes.
However, NICORETTE
®
invisi patch can also be used in
other ways,
Q
if you feel unable to stop smoking completely, or wish to
increase the time to your next cigarette with the intention
of cutting down the number of cigarettes you smoke,
Q
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
-
for prolonged periods (greater than 16 hours) where
smoking cigarettes is not allowed e.g aeroplanes,
work, social occasions
It may also help increase your motivation to quit.
When making a quit attempt a behavioural support
programme will increase your chances of success.
nicorette
®
invisi 25 mg patch: Each patch releases
25 milli

Summary of Product characteristics

Version No: 9.0
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorette invisi 10 mg patch/ NicAssist Translucent 10 mg Patch.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_‘Each patch is 9 sq.cm, containing nicotine 1.75 mg/sq.cm,
releasing a nominal 10 _
_mg of nicotine per 16 hours’. _
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Transdermal patch.
Semi-transparent, beige, imprinted 9 cm
2
rectangular TTS with rounded corners.
Centrally located on a rectangular, aluminized and siliconised release
liner.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorette Invisi Patch 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 Invisi Patch is indicated in pregnant and lactating women
making a quit
attempt (see section 4.6).
If possible, Nicorette Invisi Patch should be used in conjunction with
a behavioural
support programme.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
When making a quit attempt behavioural therapy, advice and support
will normally
improve the success rate.
It is intended that the patch is worn through the waking hours
(approximately 16
hours) being applied on waking and removed at bedtime.
_SMOKING CESSATION _
_ADULTS (OVER 18 YEARS OF AGE)_
For best results, most smokers are recommended to start on 25 mg / 16
hours patch
(Step 1) and use one patch daily for 8 weeks. Gradual weaning from the
patch should
then be initiated. One 15 mg/16 hours patch (Step 2) should be used
daily for 2
weeks followed by one 10 mg/16 hours patch (Step 3) daily for 2 weeks.
Version No: 9.0
Dose
Duration
Step 1
Nicorette invisi 25mg patch
First 8 weeks
Step 2
Nicorette invisi 15mg patch
Next 2 weeks
Step 3
Nicorette invisi 10mg patch
Last 2 weeks
Lighter smokers (i.e. those who smoke less than 10 cigarette