Nicorette Freshmint 2mg Medicated Chewing Gum

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:

Medicated chewing-gum

Therapeutic area:

Drugs used in nicotine dependence; nicotine

Authorization status:

Marketed

Authorization date:

2004-12-17

Patient Information leaflet

Package leaflet: Information for the user
2mg medicated chewing gum
freshmint 2mg medicated chewing gum
freshfruit 2mg medicated chewing gum
icy white 2mg medicated chewing gum
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 Gum is and what it is used for
2.
What you need to know before you use Nicorette Gum
3.
How to use Nicorette Gum
4.
Possible side effects
5.
How to store Nicorette Gum
6.
Contents of the pack and other information
1 WHAT NICORETTE GUM IS AND
WHAT IT IS USED FOR
Nicorette Gum 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, or when you are cutting down the number of
cigarettes you smoke while trying to stop smoking.
Nicorette Gum can also be used to relieve cravings and
withdrawal symptoms when you cannot smoke, e.g. in
smoke free areas such as on a plane or at the cinema.
Nicorette 2mg Gum 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.
2 WHAT YOU NEED TO KNOW
BEFORE YOU USE NICORETTE GUM
X
Do not use Nicorette Gum:
 if you are allergic to nicotine or any of the other
ingredients of this medicine (listed in section 6).
 if you are pregnant or breast feeding, unless advised
by your doctor.
 If you are a non-smoker or are under 18 years of age.
!
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before using
Nicorette Gum...
 if you are in hospital because of

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2023
CRN00DGZZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Freshmint 2mg Medicated Chewing Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated chewing gum contains 2 mg nicotine as a resin complex.
Excipients with known effect:
Each piece contains 0.56mg Butylated hydroxytoluene (E321)
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Medicated chewing gum.
A square, coated, cream coloured chewing gum.
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 certain circumstances, Nicorette Freshmint 2mg Gum 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.
_ _
In smokers currently unable or not ready to stop smoking abruptly,
Nicorette Freshmint 2mg gum may also be used as part of
a programme to reduce smoking prior to stopping completely.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Nicorette Freshmint 2mg Gum should be chewed slowly.
_SMOKING CESSATION_
_ADULTS_
The strength of gum to be used will depend on the smoking habit of the
individual. In general, if the patient smokes fewer than
20 cigarettes a day, Nicorette Freshmint 2mg Gum is indicated. If more
than 20 cigarettes per day are smoked Nicorette
Freshmint 4mg Gum will be needed to meet the withdrawal of the high
serum nicotine levels from heavy smoking. The patient
should be urged to stop smoking completely when starting therapy with
Nicorette Freshmint 2mg Gum.
The chewing gum should be used whenever there is an urge to smoke
according to the “chew and rest” technique described
on the pack. After about 30 minutes of such use, the gum will be
exhausted. Not more than 15 pieces of the chewing gum may
be used each da