NiQuitin Minis Mint 1.5mg lozenges

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Nicotine

Διαθέσιμο από:

Omega Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

N07BA01

INN (Διεθνής Όνομα):

Nicotine

Δοσολογία:

1.5mg

Φαρμακοτεχνική μορφή:

Lozenge

Οδός χορήγησης:

Oromucosal

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04100200; GTIN: 5000347029516 5000347029523 5012616265884

Φύλλο οδηγιών χρήσης

NIQUITIN MINIS ARE NOT SUITABLE FOR CHILDREN UNDER 12 YEARS OF AGE OR
FOR NON-SMOKERS OR OCCASIONAL SMOKERS. They may develop signs of
nicotine
overdose, including headache, sickness, stomach pain and diarrhoea.
STOPPING SMOKING STRAIGHTAWAY
ADULTS AND YOUNG PEOPLE AGED 12 YEARS AND OVER:
It is important to make every effort to stop smoking completely. But
if you do
sometimes smoke a cigarette while using NRT, don’t be discouraged
— just
keep going with your quit attempt. It may help to talk to a healthcare
professional if you are finding your quit attempt difficult.
•
Start by using 8 – 12 lozenges a day. Suck a lozenge whenever you
have an
urge to smoke.
•
Use the lozenges like this for up to 6 weeks, then gradually cut down
the
number of lozenges you use a day.
•
Once you are using only 1 – 2 lozenges a day, try to stop using them
altogether.
To increase your chances of success follow a stop smoking BEHAVIOURAL
SUPPORT
PROGRAMME – see the end of Section 1 for more details.
CUTTING DOWN ON SMOKING BEFORE YOU STOP
ADULTS AGED 18 YEARS AND OVER:
You may find it easier to quit completely later if you use NiQuitin
Minis to help
you cut down on smoking first.
When you feel a strong urge to smoke, have a lozenge instead of a
cigarette
to help you manage your cravings. Cut down the number of cigarettes
you
smoke per day by as many as possible. If you have not been able to cut
down
the number of cigarettes you smoke each day after 6 weeks, talk to a
healthcare professional.
As soon as you feel ready to stop smoking completely, follow the
instructions
above, under ‘Stopping smoking straightaway’. If you have not felt
able to
make a quit attempt within 6 months of starting to use NRT, you may
find it
helpful to talk to a healthcare professional.
CUTTING DOWN WITH NO IMMEDIATE PLANS TO STOP
ADULTS AGED 18 YEARS AND OVER:
IT IS ALWAYS BEST TO STOP SMOKING COMPLETELY, but using NRT to cut
down is less
harmful than continuing to smoke heavily. Cutting down the number of
cigarettes you smoke each day will

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NiQuitin Minis Mint 1.5 mg Lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 1.5 mg nicotine (as nicotine resinate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Compressed Lozenge (lozenge)
White to off white oval tablet with convex surfaces; one surface
bearing a
debossed “L” logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NiQuitin Minis 1.5 mg Lozenges relieve and/or prevent craving and
nicotine withdrawal symptoms associated with tobacco dependence.
They are indicated to aid smokers wishing to quit or reduce prior to
quitting, to assist smokers who are unwilling or unable to smoke, and
as a safer alternative to smoking for smokers and those around them.
NiQuitin Minis 1.5 mg Lozenges are indicated in pregnant and
lactating women making a quit attempt.
NiQuitin Minis Mint 1.5 mg Lozenges should preferably be used in
conjunction with a behavioural support programme.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_DIRECTIONS FOR USE: _
The strength of lozenge to be used will depend on the smoking habits
of the
individual.
NiQuitin Minis Mint 1.5 mg Lozenges are suitable for smokers who smoke
20
cigarettes or less a day.
One lozenge should be placed in the mouth and allowed to dissolve.
Periodically, the
lozenge should be moved from one side of the mouth to the other, and
repeated, until
the lozenge is completely dissolved (approximately 10 minutes). The
lozenge should
not be chewed or swallowed whole.
Users should not eat or drink while a lozenge is in the mouth.
Behavioural therapy advice and support will normally improve the
success rate.
ADULTS (18 YEAR AND OVER)
_ABRUPT CESSATION OF SMOKING _
Users should make every effort to stop smoking completely during
treatment with
NiQuitin Minis Mint 1.5 mg Lozenges.
Use the lozenges whenever there is an urge to smoke.
Sufficient lozenges should be used each day, usually 8-12, up to a
maximum of 15.
Continue use for up to six weeks to break t