Nicorette Cools 4mg Lozenge

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Nicotine

Disponibil de la:

Johnson & Johnson (Ireland) Limited

Codul ATC:

N07BA; N07BA01

INN (nume internaţional):

Nicotine

Dozare:

4 milligram(s)

Forma farmaceutică:

Compressed lozenge

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Drugs used in nicotine dependence; nicotine

Statutul autorizaţiei:

Marketed

Data de autorizare:

2011-12-16

Prospect

Package leaflet:
information for the user
NICORETTE COOLS 2 MG LOZENGES
NICORETTE COOLS 4 MG LOZENGES
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 doctor 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 20 cigarettes or less 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 straightaway,
then you should.
However, if you feel this is a too big step, then you may wish to try
c

Caracteristicilor produsului

Health Products Regulatory Authority
31 July 2023
CRN00D680
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Cools 4mg Lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 4 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 tablet imprinted with an "n" on one side
and "4" on the other side. The size of the lozenge is about
14 x 9 x 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorette Cools 4 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 4 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 4 mg Lozenges are suitable for smokers with high
nicotine dependency e.g. those smoking their first cigarette
of the day within 30 minutes of waking up or those who smoke more 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