NICORETTE INHALER 15 Milligram Inhalation Cartridge for Oromucosal Use

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:

15 Milligram

Φαρμακοτεχνική μορφή:

Inhalation Cartridge for Oromucosal Use

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Drugs used in nicotine dependence

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-06-03

Φύλλο οδηγιών χρήσης

Package leaflet: information for the user
15mg Inhaler
Nicotine
Read all of this leaflet carefully before you start taking 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 Inhaler is and what it is used for
2.
What you need to know before you use Nicorette Inhaler
3.
How to use Nicorette Inhaler
4.
Possible side effects
5.
How to store Nicorette Inhaler
6.
Contents of the pack and other information
1 What Nicorette Inhaler is and what it
is used for
Nicorette Inhaler 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.
It can be used to help you quit smoking completely or to
relieve cravings and withdrawal symptoms during times when
you cannot smoke, e.g. in smoke free areas such as on a
plane or at the cinema.
Nicorette Inhaler can sometimes be used in combination
with Nicorette Invisi 10mg and 15mg Patch for the treatment
of tobacco dependence as part of a stop smoking programme.
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 desire to smoke _(craving)_. This indicates that you were
dependent on nicotine.
You may also miss the frequent movements of your hand
to your mouth, inhaling, etc. which are known as habitual
movements.
When you use Nicorette Inhaler, air is drawn through the inhaler
and nicotine is released. The nicotine is absorbed into your body
through the lining of your mouth. This relieves the unpleasant
withdrawal symptoms. It will also h

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette 15mg Inhaler
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine 15mg per cartridge.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Inhalation cartridge for oromucosal use.
White to slightly coloured porous plugs in sealed, transparent plastic
cartridges.
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.
−
helping smokers temporarily abstain from smoking
In smokers currently unable or not ready to stop smoking abruptly,
Nicorette inhaler may also be used as part of a
programme to reduce smoking prior to stopping completely.
In certain circumstances, Nicorette Inhaler may be used in combination
with Nicorette Invisi 10mg and 15mg
Transdermal Patch for the treatment of tobacco dependence as part of a
stop smoking programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS (INCLUDING THE ELDERLY)_
DOSAGE
_Smoking Cessation_
The frequency of use should depend on the previous smoking habit of
the individual. Nicorette Inhaler should be used
whenever the urge to smoke is felt, up to a maximum usage of 6
cartridges per day.
In the treatment of nicotine dependence, a course not exceeding three
months is suggested, the patient stopping
smoking completely at the start of the course.
Administration of nicotine should be stopped temporarily if any
symptoms of nicotine excess occur. Nicotine intake
should be decreased by lowering dosing frequency if nicotine excess
symptoms persist (see Section 4.9).
a)
For up to 8 weeks the patient uses not less than 3 and not more than 6
cartridges each day to relieve craving.
b)
Over the following two weeks the aim is to reduce the number of
cartridges used by half, over the next two weeks
to reduce the number to zero by the last day.
c)
If abstinence has not been achieved, further courses of treatment may
be recommended, if i