Nicorette Invisi Transdermal Patch 25mg16 hours

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NICOTINE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

NICOTINE

Unit dalam pakej:

7 Pieces

Dikeluarkan oleh:

LTS Lohmann Therapie-Systeme AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NICORETTE
® INVISI TRANSDERMAL PATCH
Nicotine (10mg/16hr, 15mg/16hr and 25mg/16hr)
1
WHAT IS IN THIS LEAFLET
1.
What Nicorette
®
Invisi
Transdermal Patch is used
for
2.
How Nicorette
®
Invisi
Transdermal Patch works
3.
Before you use Nicorette
®
Invisi Transdermal Patch
4.
How to use Nicorette
®
Invisi Transdermal Patch
5. While you are using it
6. Side effects
7. Storage and Disposal of
Nicorette
®
Nicorette
®
Invisi
Transdermal Patch
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT NICORETTE
® INVISI
TRANSDERMAL PATCH IS USED FOR
Nicorette
®
Invisi Transdermal
Patch 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.
HOW
NICORETTE
® INVISI
TRANSDERMAL PATCH WORKS
When you stop smoking, or cut
down the number of cigarettes
you smoke, 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 apply Nicorette®
Invisi Transdermal Patch to the
skin, nicotine is released and
passes into your body. The
nicotine released from the patch
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® Invisi
Transdermal Patch will not give
you the “buzz” you get from
smoking a cigarette.
BEFORE YOU USE NICORETTE
®
INVISI TRANSDERMAL PATCH
_- 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 exper

Ciri produk

NICORETTE
® INVISI TRANSDERMAL PATCH
NAME OF THE PRODUCT
Nicorette
®
Invisi Transdermal Patch 10mg/16 Hours.
Nicorette
®
Invisi Transdermal Patch 15mg/16 Hours.
Nicorette
®
Invisi Transdermal Patch 25mg/16 Hours.
ACTIVE INGREDIENT
Nicotine 1.75mg/cm
2
INACTIVE INGREDIENTS
Medium chain triglycerides, basic butylated methacrylate copolymer,
polyethylenterephthalate film (PET), acrylic adhesive solution,
potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate,
siliconized PET release liner with aluminized single side.
PHARMACEUTICAL FORM
Transparent patch for topical application available in sizes of 22.5cm
2
/ 13.5cm
2
/ 9.0cm
2
.
Nicorette Invisi Transdermal Patch 10 mg/15 mg/ 25 mg per 16 Hours is
a semi-transparent, beige, imprinted, 9.0 cm
2
/13.5cm
2
/
22.5cm
2
, rectangular Transdermal Therapeutic System (TTS), with rounded
corners. It consists of pre-coated backing layer, nicotine
source layer, and a skin contact adhesive layer on a pre-coated
aluminized and siliconized release liner and contains 15.75 mg/ 23.62
mg/ 39.37 mg nicotine.
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, dizziness,
cough, constipation, gum bleeding or mouth ulcers or swelling of the
nasal
passages and the back of the throat.
Clinical studies have shown that nicotine replacement products can
help smokers quit or reduce their smoking by helping these withdrawal
symptoms.
Patch treatment mimics the fluctuations of nicotine over the day in
smokers, with no nicotine administration during sleep. Daytime
nicotine patch treatment does not give the nicotine induced sleep
disturbances seen with nicotine administration during sleep.
Phar