NiQuitin Mint minizuigtablet 4 mg, zuigtabletten

Land: Niederlande

Sprache: Niederländisch

Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Wirkstoff:

NICOTINERESINAAT SAMENSTELLING overeenkomend met ; NICOTINE

Verfügbar ab:

Omega Pharma Nederland B.V. Kralingseweg 201 3062 CE ROTTERDAM

INN (Internationale Bezeichnung):

NICOTINERESINAAT COMPOSITION corresponding to ; NICOTINE

Darreichungsform:

Zuigtablet

Zusammensetzung:

ACACIA SENEGAL ; ACESULFAAM KALIUM (E 950) ; CALCIUMCARBONAAT (E 170) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MENTHOL, RACEMISCH (DL-Vorm) ; MUNTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; PEPERMUNTOLIE ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415), ACACIA SENEGAL ; ACESULFAAM KALIUM (E 950) ; CALCIUMCARBONAAT (E 170) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MENTHOL, RACEMISCH (DL-Vorm) ; MINTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; PEPERMUNTOLIE ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415)

Verabreichungsweg:

Oromucosaal gebruik

Berechtigungsdatum:

2021-06-10

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER NIQUITIN MINT MINIZUIGTABLET 4 MG, ZUIGTABLETTEN
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 healthcare professional has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask a healthcare professional e.g. doctor, nurse, smoking cessation
adviser or pharmacist if you
need more information or advice.
•
If you get any side effects, talk to your healthcare professional.
This includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you have not achieved a reduction in
cigarette consumption or
in the number of compressed lozenges after 9 months of treatment with
Nikotin Perrigo.
Throughout this leaflet Nikotin Perrigo 4 mg compressed lozenge is
referred to as Nikotin Perrigo.
WHAT IS IN THIS LEAFLET:
1.
What Nikotin Perrigo is and what it is used for
2.
What you need to know before you take Nikotin Perrigo
3.
How to use Nikotin Perrigo
4.
Possible side effects
5.
How to store
Nikotin Perrigo
6.
Content of the pack and other information
1.
WHAT NIKOTIN PERRIGO IS AND WHAT IT IS USED FOR
Nikotin Perrigo are used to help people stop smoking. This type of
treatment is called Nicotine
Replacement Therapy or NRT. Nikotin Perrigo is indicated in adults and
adolescents (12-17 years).
Nikotin Perrigo are intended for smokers who smoke
_more than 20 cigarettes _
a day.
Nikotin Perrigo can also be used for gradual cessation for smokers who
are unwilling or unable to quit
abruptly.
Nikotin
Perrigo
should preferably
be
used
in
conjunction
with
a
behavioral
support
programme. See Section 3 “How to use Nikotin Perrigo” for further
details.
It is the nicotine in cigarettes that can make you physically addicted
to them.
•
Nikotin Perrigo help you to give up smoking by replacing some of the
nicotine you get from
cigarettes.
•
This nicotine relieves some of

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NiQuitin Mint minizuigtablet 4 mg, zuigtabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains nicotine resinate equivalent to 4 mg nicotine.
For a full list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Compressed Lozenge (lozenge)
Size to the nearest mm: L: 10 mm × W: 5 mm
White to off white oval lozenge with convex surfaces; one surface
bearing a debossed
“NIC4” logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nikotin Perrigo are to be used for the treatment of tobacco dependence
by relief of
nicotine withdrawal symptoms and cravings. Permanent cessation of
tobacco use is the
eventual objective.
Nikotin Perrigo can also be used for gradual cessation for smokers who
are unwilling or
unable to quit abruptly. Nikotin Perrigo should preferably be used in
conjunction with a
behavioral support programme.
Nikotin Perrigo is indicated in adults and adolescents (12-17 years).
In adolescents this
product should be used only after advice from a healthcare
professional.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
:_ _
Users should make every effort to stop smoking completely during
treatment with Nikotin
Perrigo.
The strength of lozenge to be used will depend on the smoking habits
of the individual.
4 mg Nikotin Perrigo are suitable for smokers who smoke more than 20
cigarettes a day.
Behavioral therapy advice and support will normally improve the
success rate
PAEDIATRIC POPULATION
:_ _
_ _
Adolescents (12-17 years) should follow the schedule of treatment for
abrupt cessation of
smoking as given above, but as data are limited, duration of use of
NRT in this age group is
restricted to 10 weeks. In adolescents this product should be used
only after advice from a
healthcare professional.
Nikotin Perrigo must not be used in children below the age of 12 due
to a lack of data on
safety and efficacy, please see section 4.3.
ADULTS (18 YEARS AND OVER)_ _
_Abrupt cessation of smoking: _
Use the lozenges whenever there