NICORETTE FRESHMINT 2 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:

2 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

BRAND:  Nicorette
DATE:  2016-02-11/MPS-a
COMPONENT NO:  651493
DESCRIPTION:  Gum 2mg Leaflet
REPLACES NO:  651424
COUNTRY:  Irland/IE
TECH. DRAWING:  CH020004  
280x180 mm 
COLORS:
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K
PDD McNeil, HBG, SWE   February 11, 2016 09:37:07
ie-mockup-pl-proposed-2mg Gum combined-BV1471
 Pg. 1
651493
I
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

your doctor, nurse or pharmacist.
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 

Produktens egenskaper

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.
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