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

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Nicotine

Disponible des:

JNTL Consumer Health I (Ireland) Limited

Codi ATC:

N07BA; N07BA01

Designació comuna internacional (DCI):

Nicotine

formulario farmacéutico:

Oromucosal spray, solution

Área terapéutica:

Drugs used in nicotine dependence; nicotine

Estat d'Autorització:

Marketed

Data d'autorització:

2017-07-14

Informació per a l'usuari

QuickMist Cool Berry
1mg/spray oromucosal spray, solution
Nicotine
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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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 infor-
mation 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 cut
down smoking before stopping completely. This
is a type of treatment called Nicotine Replace-
ment 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 th

Fitxa tècnica

Health Products Regulatory Authority
21 December 2023
CRN00DGZZ
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 e