NiQuitin 2mg Lozenge

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Nicotine

זמין מ:

Chefaro Ireland DAC

קוד ATC:

N07BA01

INN (שם בינלאומי):

Nicotine

כמות:

2 milligram(s)

טופס פרצבטיות:

Compressed lozenge

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

nicotine

מצב אישור:

Not marketed

תאריך אישור:

1999-05-31

עלון מידע

Page 1 of 8
PACKAGE LEAFLET
Page 2 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIQUITIN 2 MG LOZENGES
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.
Throughout this leaflet NiQuitin 2 mg Lozenges are referred to as
NiQuitin Lozenges.
WHAT IS IN THIS LEAFLET
1.
What NiQuitin Lozenges are and what they are used for
2.
What you need to know before you use NiQuitin Lozenges
3.
How to use NiQuitin Lozenges
4.
Possible side effects
5.
How to store NiQuitin Lozenges
6.
Contents of the pack and other information
1.
WHAT NIQUITIN LOZENGES ARE AND WHAT THEY ARE USED FOR
NiQuitin Lozenges are used to help people stop smoking. This type of
treatment is called Nicotine
Replacement Therapy or NRT.
It is the nicotine in cigarettes that can make you physically addicted
to them.
NiQuitin Lozenges help you to give up smoking by replacing some of the
nicotine you get
from cigarettes.
This nicotine relieves some of the unpleasant symptoms that smokers
may have when they try to give
up. These include feeling ill or irritable.
The nicotine can also relieve your cravings for a cigarette and help
you to resist the urge to smoke.
NiQuitin Lozenges do not have the health dangers of tobacco. This is
because they do not contain the tar,
carbon monoxide or other toxins in cigarette smoke. Some people worry
that after stopping smoking, they
may become dependent on nicotine lozenges instead. This is very rare,
and if it did happen, it is less
harmful than continuing to smoke. It also an easier habit to break.
Your chances of stopping smokin

מאפייני מוצר

Health Products Regulatory Authority
30 July 2021
CRN00CD0S
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin 2mg Lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 2 mg nicotine (as nicotine resinate).
Excipients with known effect_:_ Aspartame (E951) 6 mg, Mannitol (E421)
1036 mg and Sodium 17 mg.
For the full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Compressed lozenge
White, round compressed lozenge of 16 mm with convex surfaces,
debossed NL2 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NiQuitin Lozenges are indicated for the relief of nicotine withdrawal
symptoms including cravings associated with smoking
cessation. NiQuitin Lozenges should preferably be used in conjunction
with a behavioural support programme.
NiQuitin Lozenges are indicated in adults and adolescents aged 12
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (18 years and over)_
NiQuitin 2 mg Lozenges are suitable for smokers who have their first
cigarette of the day more than 30 minutes after waking
up.
Behavioural therapy, advice and support will normally improve the
success rate.
_ABRUPT CESSATION OF SMOKING:_
Users should MAKE EVERY EFFORT TO stop smoking completely during
treatment with NiQuitin Lozenges.
_RECOMMENDED TREATMENT SCHEDULE_:
STEP 1
WEEKS 1 TO 6
STEP 2
WEEKS 7 TO 9
STEP 3
WEEKS 10 TO 12
Initial treatment period
Step down treatment period
Step down treatment period
1 lozenge every 1 to 2 hours
1 lozenge every 2 to 4 hours
1 lozenge every 4 to 8 hours
During weeks 1 to 6 it is recommended that users take a minimum of 9
lozenges per day. Users should not exceed 15 lozenges
per day.
To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges
per day only on occasions when they are strongly
tempted to smoke.
Health Products Regulatory Authority
30 July 2021
CRN00CD0S
Page 2 of 8
Those who use the lozenges beyond 9 months are recommended to seek
additional help and advice from a healthcare
professional.