Nicospray 1 mg/spray oromucosal spray, solution

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Nicotine

متاح من:

Clonmel Healthcare Ltd

ATC رمز:

N07BA01

INN (الاسم الدولي):

Nicotine

جرعة:

1 mg/spray

الشكل الصيدلاني:

Oromucosal spray, solution

المجال العلاجي:

nicotine

الوضع إذن:

Not marketed

تاريخ الترخيص:

2019-11-08

نشرة المعلومات

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOSPRAY 1MG/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
Nicospray.
WHAT IS IN THIS LEAFLET
1.
What Nicospray is and what it is used for
2.
What you need to know before you use Nicospray
3.
How to use Nicospray
4.
Possible side effects
5.
How to store Nicospray
6.
Contents of the pack and other information
1.
WHAT NICOSPRAY IS AND WHAT IT IS USED FOR
Nicospray is used to help you stop smoking when you want to quit. This
is a type of treatment called
Nicotine Replacement Therapy (NRT).
Nicospray 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 Nicospray 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. Nicospray 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE NICOSPRAY
DO NOT USE NICOSPRAY
•
If you are
ALLERGIC
to nicotine or any of the other ingredients of this medicine (listed
in section 6).
•
If you are
UNDER THE AGE OF 18 YEARS
.
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خصائص المنتج

Health Products Regulatory Authority
01 September 2022
CRN00CZZ1
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicospray 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. Excipientwithknown effect
Ethanol 7 mg/spray
Propylene glycol 10.5 mg/spray
Benzyl alcohol 0.018 mg/spray
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
A clear colourless to brownish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicospray 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. Nicospray should
preferably be used in conjunction with a behavioural support program.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Subjects should stop smoking completely during the course of treatment
with Nicospray.
_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 day. By the end of week 9
subjects should be using HALF the average number of
sprays per day that was used in Step I.
STEP III: WEEKS 10-12
Continue reducing the number of sprays per day so that subjects are
not us