NiQuitin CLEAR 7 mg/24 hrs transdermal patch

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Nicotine

Dostopno od:

Chefaro Ireland DAC

Koda artikla:

N07BA; N07BA01

INN (mednarodno ime):

Nicotine

Odmerek:

7 milligram(s)/24 hours

Farmacevtska oblika:

Transdermal patch

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Drugs used in nicotine dependence; nicotine

Status dovoljenje:

Marketed

Datum dovoljenje:

2002-09-27

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIQUITIN CLEAR
7 mg, 14 mg, 21 mg/24 hrs 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 CLEAR transdermal patches are
referred to as NIQUITIN
CLEAR.
WHAT IS IN THIS LEAFLET:
1. What NIQUITIN CLEAR is and what it is used for
2. What you need to know before you use NIQUITIN CLEAR
3. How to use NIQUITIN CLEAR
4. Possible side effects
5. How to store NIQUITIN CLEAR
6. Contents of the pack and other information
1. WHAT NIQUITIN CLEAR IS AND WHAT IT IS USED FOR
NiQuitin Clear 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 Clear 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 CLEAR). Each
strength comes in its own pack.
It is the nicotine in cigarettes that can make you addicted to them.
NiQuitin Clear 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 Clear PATCHES MAY BE USED together with any oral NiQuitin
(lozenge, mini lozenge or gum)
if you have relapsed after trying to quit with NRT, wh

Lastnosti izdelka

Health Products Regulatory Authority
16 June 2021
CRN00C8R3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin CLEAR 7 mg/24 hrs transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NiQuitin CLEAR is a transdermal delivery system for transdermal use
available in systems of 7 cm
2
containing36 mg
nicotine,equivalent to 5.1 mg/cm
2
of nicotine and delivering 7 mg over 24 hours.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Transdermal patch.
Each patch is rectangular and is comprised of clear backing and a
protective liner which is removed prior to use.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NiQuitin CLEAR is indicated for the relief of nicotine withdrawal
symptoms including cravings as an aid to smoking cessation. If
possible, when stopping smoking, NiQuitin CLEAR should be used in
conjunction with a behavioural support programme.
NiQuitin CLEAR is indicated in adults and adolescents aged 12 years
and over.
NiQuitin CLEAR can be used in combination with oral nicotine forms
(gums or lozenges) in smokers who have relapsed after
nicotine replacement therapy (NRT), or when monotherapy with one NRT
is not sufficient to control cravings, or as first line
treatment in smokers with a high level of dependence, such as those
smoking 10 or more cigarettes in a day. (See section 4.2).
Adolescents should not quit with a Combination NRT regime.
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 CLEAR. Concurrent
behavioural support is recommended, as such programmes have been shown
to be beneficial for smoking cessation.NiQuitin
CLEAR patches should be applied once a day, at the same time each day
and preferably soon after waking and worn
continuously for 24 hours.
In some instances (e.g. in heavy smokers