Nicorette Quickmist 1 mg/spray oromucosal spray, solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Nicotine

Доступна с:

Johnson & Johnson (Ireland) Limited

код АТС:

N07BA; N07BA01

ИНН (Международная Имя):

Nicotine

дозировка:

1 milligram(s)

Фармацевтическая форма:

Oromucosal spray, solution

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

Drugs used in nicotine dependence; nicotine

Статус Авторизация:

Marketed

Дата Авторизация:

2012-08-03

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORETTE QUICKMIST 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.
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 or to cut down smoking before
stopping completely. 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE QUICKMIST
DO NOT USE NICORETTE QUI

Характеристики продукта

Health Products Regulatory Authority
31 July 2023
CRN00D680
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette Quickmist 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 7.1 mg/spray
Propylene glycol 11 mg/spray
Butylated hydroxytoluene 363 ng/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 or to cut down smoking
before stopping completely. Permanent cessation of tobacco
use is the final objective. Nicorette QuickMist 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.
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 30 minutes