NICORETTE FRESHMINT 4 Base Milligrams Medicated Chewing Gum

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

NICOTINE RESIN

Tillgänglig från:

McNeil Healthcare (Ireland) Ltd

ATC-kod:

N07BA01

INN (International namn):

NICOTINE RESIN

Dos:

4 Base Milligrams

Läkemedelsform:

Medicated Chewing Gum

Receptbelagda typ:

Product not subject to medical prescription

Terapiområde:

Drugs used in nicotine dependence

Bemyndigande status:

Authorised

Tillstånd datum:

2005-01-14

Bipacksedel

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 do not smoke
n in children
!
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 pains in the
chest.
n

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Freshmint 4 mg Medicated Chewing Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated chewing gum containing 4 mg nicotine as a resin complex.
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 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 Freshmint 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 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 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
swallowed being destroyed by the liver.
Administration of nicotine should be