NIQUITIN STRIPS MINT

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

NICOTINE

זמין מ:

Chefaro Ireland DAC

קוד ATC:

N07BA01

INN (שם בינלאומי):

NICOTINE

כמות:

2.5 Milligram

טופס פרצבטיות:

orodispersible film

מסלול נתינה (של תרופות):

place on the tongue

יחידות באריזה:

Each pack contains 10, 15, 30 or 60 sachets.

סוג מרשם:

Product not subject to medical prescription

קבוצה תרפויטית:

Drugs used in nicotine dependence

איזור תרפויטי:

nicotine

סממני תרפויטית:

NiQuitin Films are to be used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt

מצב אישור:

Marketed

תאריך אישור:

2011-08-12

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin Strips Mint 2.5mg orodispersible film
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible film contains 2.5 mg nicotine.
Contains ethanol, not more than 3.9 mg per film.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Orodispersible Film
Transparent film approximately 20 mm by 30 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NiQuitin Films are to be used for the treatment of tobacco dependence
by relief of nicotine withdrawal symptoms,
including cravings, during a quit attempt (See section 5.1).
Permanent cessation of tobacco use is the eventual
objective.
NiQuitin Films should preferably be used in conjunction with a
behavioural support programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
NiQuitin Films are suitable for smokers who have their first cigarette
of the day more than 30 minutes after waking up.
Users should not eat or drink while a nicotine film is in the mouth.
Behavioural therapy, advice and support will normally improve the
success rate.
_Adults (18 years and over)_
Users should make every effort to stop smoking completely during
treatment with NiQuitin Films.
_Recommended treatment schedule_:
During weeks 1 to 6 it is recommended that users take a minimum of 9
nicotine films per day. Users should not exceed
15 nicotine films per day.
STEP 1
WEEKS 1 TO 6
STEP 2
WEEKS 7 TO 9
STEP 3
WEEKS 10 TO 12
Initial treatment period
Step down treatment
period
Step down treatment
period
1 nicotine film every 1 to
2 hours
1 nicotine film every 2
to 4 hours
1 nicotine film every 4
to 8 hours
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_