Nicorette icy mint 4 mg gum

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

NICOTINE RESINATE

Saadav alates:

JNTL (MALAYSIA) SDN. BHD.

INN (Rahvusvaheline Nimetus):

NICOTINE RESINATE

Ühikuid pakis:

105pieces Pieces; 15 Pieces

Valmistatud:

McNeil AB

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NICORETTE
® ICY MINT GUM
Nicotine (as resinate) (2mg and 4mg)
1
WHAT IS IN THIS LEAFLET
1.
What Nicorette
®
Icy Mint
Gum is used for
2.
How Nicorette
®
Icy Mint
Gum works
3.
Before you use Nicorette
®
Icy Mint Gum
4.
How to use Nicorette
®
Icy
Mint Gum
5. While you are using it
6. Side effects
7. Storage and disposal of
Nicorette
®
Icy Mint Gum
8. Product description
9. Manufacturer and Product
Registration Holders
10. Date of revision
WHAT NICORETTE
® ICY MINT
GUM
IS USED FOR
Nicorette® Icy Mint Gum is
used to relieve withdrawal
symptoms and reduce the
cravings for nicotine that you
get when you try to stop
smoking.
HOW
NICORETTE
® ICY MINT GUM
WORKS
When you stop smoking, your
body misses the nicotine that
you have been absorbing. You
may experience unpleasant
feelings and a strong desire to
smoke (craving). This indicates
you were dependent on nicotine.
When you chew Nicorette® Icy
Mint Gum, nicotine is released
and passes into your body
through the lining of your
mouth. The nicotine released
from the gum is sufficient to
relieve the unpleasant
withdrawal symptoms such as
irritability, restlessness, anxiety,
and frustration. It will also help
to relieve the sudden intense
urge to smoke but Nicorette®
Icy Mint Gum will not give you
the “buzz” you get from
smoking a cigarette.
BEFORE YOU USE NICORETTE
® ICY
MINT GUM
_When you must not use it _
Do not use
•
If you have an allergy to
nicotine or any of the other
ingredients.
•
If you are pregnant, trying
to get pregnant or think you
may be pregnant.
•
If you are breast-feeding.
Ask your doctor or
pharmacist for advice.
_Before you start to use it _
Talk to your doctor or
pharmacist
•
If you have experienced a
serious cardiovascular event
(heart disease), or
hospitalization for a
cardiovascular complaint, in
the previous 4 weeks (e.g.,
stroke, myocardial
infarction, unstable angina,
cardiac arrhythmia,
coronary artery bypass graft
and angioplasty) or if you
suffer from uncontrolled
hypertens

Toote omadused

NICORETTE
® ICY MINT GUM
NAME OF THE PRODUCT
Nicorette
®
icy mint 2mg gum
Nicorette
®
icy mint 4mg gum
ACTIVE INGREDIENT
Nicotine 2mg and 4mg
INACTIVE INGREDIENTS
-
Nicorette
®
icy mint 2mg gum • nicotine (as resinate): Chewing gum base,
levomenthol, acesulfame
potassium, talc, magnesium oxide (light), xylitol, peppermint oil,
sodium carbonate anhydrous, and
sodium hydrogen carbonate.
-
Nicorette
®
icy mint 4mg gum • nicotine (as resinate): Chewing gum base,
xylitol, levomenthol,
quinolone yellow E104 Al-lake, acesulfame potassium, magnesium oxide
(light), peppermint oil,
sodium carbonate anhydrous, and talc.
PHARMACEUTICAL FORM
Nicorette
®
icy mint 2mg gum • nicotine (as resinate):
A white coloured coated square chewing gum with a size of about 15 x
15 x 6 mm
Nicorette
®
icy mint 4mg gum • nicotine (as resinate):
A crème coloured coated square chewing gum with a size of about 15 x
15 x 6 mm
PHARMACOLOGY
Pharmacodynamics
Pharmacotherapeutic group: Drug used in nicotine dependence. ATC code:
N07B A01
A sudden stop of smoking for long term smokers will experience the
following withdrawal symptoms:
urge
or
craving
to
smoke,
dysphoria
or
depressed
mood,
insomnia,
irritability,
frustration
or
aggression,
anxiety,
difficulty
in
concentrating,
restlessness or
impatience, reduced
heart
rate,
increased appetite or increase in weight.
Clinical studies have shown that nicotine replacement products can
help smokers quit or reduce their
smoking by helping these withdrawal symptoms.
Pharmacokinetics
Nicotine administered from a piece of nicotine chewing gum depends on
the quantity of nicotine
released into the oral cavity and readily absorbed through the oral
mucosa. Maximum blood
concentration is achieved after 30 minutes of chewing and is
proportionate to the concentration 20-
30 minutes after smoking a cigarette.
The major eliminating organ is the liver. Greatly impaired
kidney function is assumed to affect total clearance of nicotine.
INDICATION
Nicorette
®
is used for the treatment of tobacco dependence b