Nicorette Fruit 4 mg Lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nicotine

Available from:

JNTL Consumer Health I (Ireland) Limited

ATC code:

N07BA; N07BA01

INN (International Name):

Nicotine

Pharmaceutical form:

Compressed lozenge

Therapeutic area:

Drugs used in nicotine dependence; nicotine

Authorization status:

Marketed

Authorization date:

2017-12-22

Patient Information leaflet

Package leaflet:
information for the user
NICORETTE FRUIT 2 MG LOZENGES
NICORETTE FRUIT 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 Fruit.
WHAT IS IN THIS LEAFLET:
1. What Nicorette Fruit are and what they are used for
2. What you need to know before you take Nicorette Fruit
3. How to use Nicorette Fruit
4. Possible side effects
5. How to store Nicorette Fruit
6. Contents of the pack and other information
1 WHAT NICORETTE FRUIT 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 Fruit 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 Fruit 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
cutting

Summary of Product characteristics

Health Products Regulatory Authority
26 February 2024
CRN00DQ4L
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Fruit 4 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 4 mg nicotine (as nicotine resinate).
Excipients with known effects:
Sulphites (0.000096 mg per lozenge).
For a 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 7mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorette Fruit 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 Fruit 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 Fruit 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 Fruit 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 sh