Nicorette 4mg 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:

1997-10-14

Patient Information leaflet

Package leaflet: Information for the user
4mg medicated chewing gum
freshmint 4mg medicated chewing gum
freshfruit 4mg medicated chewing gum
icy white 4mg 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
withdrawl symptoms when you cannot smoke, e.g. in
smoke free areas such as on a plane or at the cinema.
2 WHAT YOU NEED TO KNOW BEFORE
YOU USE NICORETTE GUM
X
Do not use Nicorette Gum:
n if you are allergic to nicotine or any of the other
ingredients of this medicine (listed in section 6).
n if you are pregnant or breast feeding, unless
advised by your doctor.
n 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 ....
n if you are in hospital because of heart disease
(including heart attack, disorders of heart rate or
rhythm, or stroke).
n if you have high blood pressure, bad circulation.
n
if you have persistent indigestion or pa

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2023
CRN00DGZZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette 4mg Medicated Chewing-gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH PIECE OF MEDICATED CHEWING GUM CONTAINING 4 MG NICOTINE AS A
RESIN COMPLEX.
Excipients with known effect:
Each piece contains:
0.56mg Butylated hydroxytoluene (E321)
178.97mg of Sorbitol (E420)
Flavour for smoker (contains Cinnamal, Cinnamyl alcohol, Citral,
Citronellol, Eugenol, Geraniol, Isoeugenol, Limonene, Linalool)
11 mg/chewing gum.
0.616mg ethanol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated Chewing-gum
A square, yellow medicated 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 smokers currently unable or not ready to stop smoking abruptly,
Nicorette 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 4mg 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 2mg Gum is indicated. If more than 20
cigarettes per day are smoked Nicorette 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 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 that 15 pieces of the chewing gum
may be used each day. Absorption of nicotine is through the buccal
mucosa, any nicotine which is swall