NiQuitin Mint minizuigtablet 2 mg, zuigtabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NICOTINERESINAAT SAMENSTELLING overeenkomend met ; ; NICOTINE

Beschikbaar vanaf:

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

INN (Algemene Internationale Benaming):

NICOTINERESINAAT COMPOSITION corresponding to ; ; NICOTINE

farmaceutische vorm:

Zuigtablet

Samenstelling:

ACESULFAAM KALIUM (E 950) ; ARABISCHE GOM (E 414) ; KALIUMWATERSTOFCARBONAAT (E 501 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MUNTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415), ACESULFAAM KALIUM (E 950) ; ARABISCHE GOM (E 414) ; KALIUMWATERSTOFCARBONAAT (E 501 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MINTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415)

Toedieningsweg:

Oromucosaal gebruik

Autorisatie datum:

2021-06-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER NIQUITIN MINT MINIZUIGTABLET 2 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 2 mg compressed lozenges are
referred to as Nikotin.
WHAT IS IN THIS LEAFLET:
1.
What Nikotin is and what it is used for
2.
What you need to know before you take Nikotin
3.
How to use Nikotin
4.
Possible side effects
5.
How to store
Nikotin
6.
Content of the pack and other information
1.
WHAT NIKOTIN IS AND WHAT IT IS USED FOR
Nikotin are used to help people stop smoking. This type of treatment
is called Nicotine Replacement
Therapy or NRT. Nikotin is indicated in adults and adolescents (12-17
years).
Nikotin are intended for smokers who smoke
_20 cigarettes or less_
a day.
Permanent cessation of tobacco use is the eventual objective. Nikotin
can also be used for Gradual
cessation for smokers who are unwilling or unable to quit abruptly.
Nikotin should preferably be
used in conjunction with a behavioral support programme. See Section 3
“How to use Nikotin” for
further details.
It is the nicotine in cigarettes that can make you physically addicted
to them.
•
Nikotin help you to give up smoking by replacing some of the nicotine
you get from cigarettes.
•
This nicotine relieves some of the unpleasant symptoms that smokers
ma

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NiQuitin Mint minizuigtablet 2 mg, zuigtabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains nicotine resinate equivalent to 2 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 “ NIC2”
logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nikotin Perrigo is 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.
2 mg Nikotin Perrigo is suitable for smokers who smoke 20 cigarettes
or less 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. Adolescents should not quit with a
Combination NRT Regimen.
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)_ _
Monotherapy