NiQuitin 21mg/24hrs transdermal patches

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Nicotine

Prieinama:

Chefaro Ireland DAC

ATC kodas:

N07BA; N07BA01

INN (Tarptautinis Pavadinimas):

Nicotine

Dozė:

21 milligram(s)/24 hours

Vaisto forma:

Transdermal patch

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Drugs used in nicotine dependence; nicotine

Autorizacija statusas:

Marketed

Leidimo data:

1999-05-31

Pakuotės lapelis

FONT SIZE
8PT/9PT LEADING
94% HORIZONTAL SCALE
PACKAGE LEAFLET: INFORMATION FOR THE USER
7mg, 14mg, 21mg/24hrs
transdermal patches
Nicotine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this
leaflet or as your healthcare professional has told you.
>
Keep this leaflet. You may need to read it again.
>
Ask a healthcare professional (e.g. doctor, nurse,
smoking cessation adviser or pharmacist) if you
need more information or advice.
>
If you get any side effects talk to your healthcare
professional. This includes any possible side effects
not listed in this leaflet. See section 4.
>
Throughout this leaflet NIQUITIN transdermal
patches are referred to as NIQUITIN.
WHAT IS IN THIS LEAFLET
1. What NIQUITIN is and what it is used for
2. What you need to know before you use NIQUITIN
3. How to use NIQUITIN
4. Possible side effects
5. How to store NIQUITIN
6. Contents of the pack and other information
1. WHAT NIQUITIN IS AND WHAT IT IS USED FOR
NiQuitin are SKIN PATCHES THAT DELIVER NICOTINE TO
HELP PEOPLE STOP SMOKING. This type of treatment
is called Nicotine Replacement Therapy (or NRT for
short). NiQuitin patches come in three strengths:
21mg, 14mg and 7mg/24hrs. People wanting to quit
smoking START ON A STRONGER PATCH AND GRADUALLY
SWITCH TO WEAKER ONES (SEE SECTION 3: HOW TO USE
NIQUITIN). Each strength comes in its own pack.
It is the nicotine in cigarettes that can make you
addicted to them. NiQuitin helps you give up smoking
by replacing some of the nicotine you get from
cigarettes. Each patch slowly releases nicotine into the
body. This relieves some of the unpleasant symptoms
that smokers may get when they try to quit, relieves
cravings for a cigarette and helps to resist the urge to
smoke.
NiQuitin PATCHES MAY BE USED TOGETHER WITH ANY
ORAL NIQUITIN (lozenge, mini lozenge or gum) if you
have relapsed after trying to quit with NRT, when
one NiQuitin product is not enough to control your
c

Prekės savybės

Health Products Regulatory Authority
06 October 2020
CRN009CMD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin 21mg/24hrs transdermal patches
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 22 cm
2
transdermal patch contains 114 mg nicotine, equivalent to 5.1 mg/cm
2
of nicotine and delivers 21 mg over 24
hours.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Each patch is rectangular and is comprised of an outer matt pinkish
tan-coloured layer, a middle silver layer and an outer clear
layer which is removed prior to use.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NiQuitin is indicated for the relief of nicotine withdrawal symptoms
including cravings as an aid to smoking cessation. If
possible, when stopping smoking, NiQuitin should be used in
conjunction with a behavioural support programme.
NiQuitin patch is indicated in adults and adolescents aged 12 years
and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS (18 YEARS AND OVER)
The patches should be used as directed below. Prior to initiation of
therapy users should be committed to stopping smoking.
During a quit attempt, every effort should be made to stop smoking
during treatment with NiQuitin. Concurrent behavioural
support is recommended, as such programmes have been shown to be
beneficial for smoking cessation.
In some instances (e.g. in heavy smokers, or those who have relapsed
after NRT before, or when one NRT is not enough to
control cravings), it may also be beneficial to utilise more than one
form of NiQuitin concurrently. For example, smokers who
have difficulty controlling cravings when using a patch alone may use
a gum, a lozenge or a mini lozenge to support sudden
cravings.
NiQuitin patches may be used alone or in combination with any NiQuitin
1.5mg/2mg/4mg lozenge, mini lozenge or gum (refer
to detailed combination therapy posology below).
NiQuitin patches should be applied once a day, at the same time each
day and preferably soon after waki