Nicorette 2mg Medicated chewing gum

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NICOTINE

Available from:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC code:

N07BA01

INN (International Name):

NICOTINE 2 mg

Pharmaceutical form:

MEDICATED CHEWING-GUM

Composition:

NICOTINE 2 mg

Prescription type:

OTC

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2006-08-30

Patient Information leaflet

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 heart disease
(including heart attack, disorders of heart rate or
rhythm, or stroke).
■
if you have high blood pressure, bad circulation.
■
if you have persistent indigestion or pai

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Nicorette 2mg Medicated Chewing Gum
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of mediated chewing gum contains 2 mg nicotine as a resin
complex.
Excipients with known effect:
Each piece contains:
0.56mg Butylated hydroxytoluene (E321)
190.25mg of Sorbitol (E420)
0.616mg ethanol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Medicated chewing gum
A square, beige 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 certain circumstances, Nicorette 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 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 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 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
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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 than 15 pieces of the chewing gum may be used each day.
Absorption of nicotine is through the
buccal mucosa,