NICORETTE QUICKMIST 1 Milligram Oromucosal Spray, Soln

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

NICOTINE

זמין מ:

McNeil Healthcare (Ireland) Ltd

קוד ATC:

N07BA01

INN (שם בינלאומי):

NICOTINE

כמות:

1 Milligram

טופס פרצבטיות:

Oromucosal Spray, Soln

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Drugs used in nicotine dependence

מצב אישור:

Authorised

תאריך אישור:

2012-08-03

עלון מידע

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 doctor or pharmacist has
told you.
-
Keep this leaflet. You may need to read it
again.
-
Ask your pharmacist if you need more
information or advice.
-
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leafet. See section 4.
-
You must talk to your doctor if you have not
been able to stop smoking after 6 months of
treatment with Nicorette QuickMist.
What is in this leaflet
1. What Nicorette QuickMist is and what it is
used for
2. What you need to know before you use
Nicorette QuickMist
3. How to use Nicorette QuickMist
4. Possible side effects
5. How to store Nicorette QuickMist
6. Contents of the pack and other information
1
WHAT NICORETTE QUICKMIST IS AND WHAT
IT IS USED FOR
Nicorette QuickMist is used to help you stop
smoking when you want to quit. This is a type of
treatment called Nicotine Replacement Therapy
(NRT).
Nicorette QuickMist relieves nicotine withdrawal
symptoms including cravings, symptoms you get
when stopping smoking. When you suddenly
stop providing nicotine from tobacco to your
body, you get hit by different kinds of unpleasant
feelings called withdrawal symptoms. By using
Nicorette QuickMist you can prevent or reduce
these unpleasant feelings and cravings for
smoking. This is because you continue to
provide a small amount of nicotine to your body
for a short period of time. Nicorette QuickMist
does not contain the tar, carbon monoxide or
other toxins in cigarette smoke.
To improve the chances of helping you to stop
smoking, you should also seek counselling
advice and support, if you can.
2
BEFORE YOU USE
NICORETTE QUICKMIST
Do not use Nicorette QuickMist
-
If you are allergic to nicotine or any of this
medicine (listed in section 6).
-
If you are under the age of 18 years.
-
If you have never smoked.
Warnings and precautions
Tal

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Quickmist 1mg/spray Oromucosal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One spray delivers 1 mg nicotine in 0.07 ml solution. 1 ml solution contains 13.6 mg nicotine.
Excipient with known effect: ethanol (less than 100 mg of ethanol/spray).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
A clear to weakly opalescent, colourless to light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorette QuickMist is to be used for the treatment of tobacco dependence in adults by relief of nicotine withdrawal
symptoms, including cravings, during a quit attempt. Permanent cessation of tobacco use is the eventual objective.
Nicorette QuickMist should preferably be used in conjunction with a behavioral support program.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Subjects should stop smoking completely during the course of treatment with Nicorette QuickMist.
_Adults and Elderly_
The following chart lists the recommended usage schedule for the oromucosal spray during full treatment (Step I) and
during tapering (Step II and Step III). Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing episode
and do not exceed 64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period.
STEP I: WEEKS 1-6 
Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings
emerge. If after a single spray cravings are not controlled within a few minutes, a
second spray should be used. If 2 sprays are required, future doses may be delivered as
2 consecutive sprays.
Most smokers will require 1-2 sprays every 30 minutes to 1 hour.
STEP II: WEEKS 7-9 
Start reducing the number of sprays per