NICORETTE COOLS 2 Milligram Lozenges

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

NICOTINE RESINATE

Disponible des:

McNeil Healthcare (Ireland) Ltd

Codi ATC:

N07BA01

Designació comuna internacional (DCI):

NICOTINE RESINATE

Dosis:

2 Milligram

formulario farmacéutico:

Lozenges

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Drugs used in nicotine dependence

Estat d'Autorització:

Authorised

Data d'autorització:

2011-12-16

Informació per a l'usuari

Package leaflet:
information for the user
NICORETTE COOLS 2 MG LOZENGE
NICORETTE COOLS 4 MG LOZENGE
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 has 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.
-
You must talk to a healthcare
professional if after 9 months you still
have difficulties refraining from
smoking, without the help of Nicorette
Cools.
What is in this leaflet:
1. What Nicorette Cools are and what
they are used for
2. What you need to know before you
take Nicorette Cools
3. How to use Nicorette Cools
4. Possible side effects
5. How to store Nicorette Cools
6. Contents of the pack and other
information
1
What Nicorette Cools Are And What They Are
Used For
This medicine is used to relieve
withdrawal symptoms and reduce the
cravings for nicotine that you get when
you try to stop smoking or when you are
cutting down the number of cigarettes
you smoke while trying to stop smoking.
The treatment is for adult smokers 18
years and above.
Nicorette Cools 2 mg Lozenges are
suitable for smokers who have a low
nicotine dependency e.g., who either
have their first cigarette of the day more
than 30 minutes after waking up or who
smoke fewer than 20 cigarettes per day.
Nicorette Cools 4 mg lozenges are
suitable for smokers with high nicotine
dependency e.g., those smoking their
first cigarette of the day within 30
minutes after waking up or those who
smoke more than 20 cigarettes per day.
This medicine can help you give up
smoking straightaway or to cut down
smoking before stopping completely. If
you think you can stop smoking straight-
away, then you should. However, if you
feel this is a too big step, then you may

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Cools 2mg Lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 2 mg nicotine (as nicotine resinate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Compressed lozenge (lozenge)
An oval, white to off-white lozenge imprinted with an “n” on one
side and “2” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorette Cools 2 mg Lozenges are to be used for the treatment of
tobacco dependence by relief of nicotine withdrawal
symptoms and cravings in smokers 18 years and above. Permanent
cessation of tobacco use is the eventual objective.
Nicorette Cools 2 mg Lozenges should preferably be used in conjunction
with a behavioural support programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Selecting the strength of lozenge to be used will depend on the
smoking habits of the individual.
_Adults_
Nicorette Cools 2 mg Lozenges are suitable for smokers with low
nicotine dependency e.g. those smoking their first
cigarette of the day more than 30 minutes after waking up or those who
smoke fewer than 20 cigarettes per day.
Lozenges should not be used for more than 9 months. If users still
feel the need for treatment, a healthcare professional
should be consulted.
Behavioural therapy advice and support will normally improve the
success rate.
_Abrupt cessation of smoking_:
The patient should make every effort to stop smoking completely during
treatment with Nicorette Cools Lozenges.
The lozenges should be used whenever there is an urge to smoke.
Sufficient lozenges should be used each day and most smokers usually
require 8 to 12, not to exceed 15 lozenges.
The duration of treatment is individual, but up to six weeks treatment
is recommended to break the habit of smoking.
The nicotine dose should then be gradually reduced, by decreasing the
total number of lozenges used per day. The
treatment should be stopped, when the daily consumption is down to 1-2
lozenges.
Use a lozenge w