Nicorette QuickMist Cool Berry 1 mg/spray, oromucosal spray, solution

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Nicotine

Fáanlegur frá:

Johnson & Johnson (Ireland) Limited

ATC númer:

N07BA; N07BA01

INN (Alþjóðlegt nafn):

Nicotine

Skammtar:

1 milligram(s)/dose

Lyfjaform:

Oromucosal spray, solution

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Drugs used in nicotine dependence; nicotine

Leyfisstaða:

Marketed

Leyfisdagur:

2017-07-14

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORETTE QUICKMIST COOL BERRY 1 MG/SPRAY OROMUCOSAL SPRAY, SOLUTION
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 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 leaflet. See section 4.
-
You must talk to a doctor if you have not been able to stop smoking
after 6 months of treatment with
Nicorette QuickMist Cool Berry.
WHAT IS IN THIS LEAFLET
1.
What Nicorette QuickMist Cool Berry is and what it is used for
2.
What you need to know before you use Nicorette QuickMist Cool Berry
3.
How to use Nicorette QuickMist Cool Berry
4.
Possible side effects
5.
How to store Nicorette QuickMist Cool Berry
6.
Contents of the pack and other information
1.
WHAT NICORETTE QUICKMIST COOL BERRY IS AND WHAT IT IS USED FOR
Nicorette QuickMist Cool Berry is used to help you stop smoking when
you want to quit or to cut down
smoking before stopping completely. This is a type of treatment called
Nicotine Replacement Therapy
(NRT).
Nicorette QuickMist Cool Berry 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
Cool Berry, 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 Cool Berry 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 counsel

Vara einkenni

Health Products Regulatory Authority
31 July 2023
CRN00D680
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette QuickMist Cool Berry 1 mg/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).
Propylene glycol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
A clear to weakly opalescent, colourless to yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorette QuickMist Cool Berry is to be used for the treatment of
tobacco dependence in adults by relief of nicotine withdrawal
symptoms, including cravings, during a quit attempt or to cut down
smoking before stopping completely. Permanent cessation
of tobacco use is the final objective. Nicorette QuickMist Cool Berry
should preferably be used in conjunction with a behavioral
support program.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Behavioural therapy advice and support will normally improve the
success rate.
_Adults and Elderly _
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.
_Abrupt Smoking Cessation_
For smokers willing and ready to stop smoking immediately.
Subjects should stop smoking completely during the course of treatment
with Nicorette QuickMist Cool Berry.
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).
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