NICORETTE INVISI 10 mg/16 h Milligram Transdermal Patch

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

NICOTINE

Διαθέσιμο από:

McNeil Healthcare (Ireland) Ltd

Φαρμακολογική κατηγορία (ATC):

N07BA01

INN (Διεθνής Όνομα):

NICOTINE

Δοσολογία:

10 mg/16 h Milligram

Φαρμακοτεχνική μορφή:

Transdermal Patch

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Drugs used in nicotine dependence

Καθεστώς αδειοδότησης:

Transfer Pending

Ημερομηνία της άδειας:

2008-09-05

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORETTE INVISI
10MG/16 HOURS
15MG/16 HOURS
TRANSDERMAL PATCH
Nicotine
A GUIDE FOR USERS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Nicorette Invisi Patch is and what it is used for
2. What you need to know before you use Nicorette Invisi Patch
3. How to use Nicorette Invisi Patch
4. Possible side effects
5. How to store Nicorette Invisi Patch
6. Contents of the pack and other information
1. WHAT NICORETTE INVISI PATCH IS AND WHAT IT IS USED FOR
Nicorette Invisi Patch is a nicotine replacement therapy (NRT). It is
used to relieve withdrawal symptoms and reduce the cravings for
nicotine that you get when you try to stop smoking.
Nicorette Invisi 10mg and 15mg Patch can sometimes be used in
combination with either Nicorette 2mg Gum or Nicorette 15mg
Inhaler for the treatment of tobacco dependence as part of a stop
smoking programme.
Nicorette
®
Invisi 15mg Patch: Each patch releases 15 milligrams of
nicotine, over 16 hours.
Nicorette
®
Invisi 10mg Patch: Each patch releases 10 milligrams of
nicotine, over 16 hours.
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 apply a Nicorette Invisi Patch to the skin, nicotine is
released and passes into your body through the skin. The nicotine
released is sufficient to relieve the unpleasant nicotine withdrawal
symptoms and your cravings to smoke.
2. WHAT YOU NEED TO KNOW BEFORE YOU US

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Invisi 10mg/16 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine, 10mg released over 16 hours use. Each patch is 9.0 cm
2
, containing 1.75mg nicotine / cm
2
.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
Beige semi-transparent patch consisting of pre-coated backing layer,
nicotine source layer, a skin contact adhesive layer
on a pre-coated, aluminized and siliconised release layer with
“nicorette” printed on the top face of the patch. The patch
is approximately 3 x 3cm (with rounded corners).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of tobacco dependence by relieving nicotine craving
and withdrawal symptoms, thereby facilitating
smoking cessation in smokers motivated to quit.
In certain circumstances, Nicorette Invisi 10mg Patch may be used in
combination with Nicorette 2mg Gum or
Nicorette 15mg Inhaler for the treatment of tobacco dependence as part
of a stop smoking programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_SMOKING CESSATION_
_ADULTS AND THE ELDERLY_
The strength of patch to be used will depend on the smoking habit of
the individual. In general, if the patient smokes
fewer than 20 cigarettes a day it is recommended that they start on
the 15mg Invisi Patch and then step down to the
Nicorette 10mg Invisi Patch. If more than 20 cigarettes per day are
smoked it is recommended that they start on the
25mg Invisi Patch and then step down to the Nicorette 15mg and 10mg
Invisi Patch.
Experience with the treatment of nicotine dependence shows that
success rates are improved if patients also receive
support therapy and counselling.
The patch should be applied to an intact area of the skin upon waking
up in the morning and removed at bedtime.
Patch treatment mimics the fluctuations of nicotine over the day in
smokers, with no nicotine administration during
sleep. Daytime nicotine patch treatment does not give the nicotine
induced sleep