NiQuitin Clear 21mg patches

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Nicotine

זמין מ:

Omega Pharma Ltd

קוד ATC:

N07BA01

INN (שם בינלאומי):

Nicotine

כמות:

21mg/24hour

טופס פרצבטיות:

Transdermal patch

מסלול נתינה (של תרופות):

Transdermal

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04100200; GTIN: 5000347078217 5000347078224

עלון מידע

The Marketing Authorisation holder is Omega Pharma Ltd,
32 Vauxhall Bridge Road, London, SW1V 2SA, UK and all enquiries
should be sent to this address.
NIQUITIN is a registered trade mark of
ELAN PHARMA INTERNATIONAL LTD.
This leaflet was last revised in October 2015.
LF10407A
31036125

מאפייני מוצר

OBJECT 1
NIQUITIN CLEAR 21MG PATCH / NIQUITIN PRE-QUIT
CLEAR 21MG PATCH
Summary of Product Characteristics Updated 30-Dec-2015 | Omega Pharma
Ltd
1. Name of the medicinal product
NiQuitin Clear 21 mg Patch
NiQuitin Pre-Quit Clear 21 mg Patch
2. Qualitative and quantitative composition
NiQuitin Clear is a transdermal delivery system for topical
application available in systems of 22 cm
2
containing 114 mg nicotine, equivalent to 5.1 mg/cm
2
of nicotine and delivering 21 mg over 24 hours.
3. Pharmaceutical form
Transdermal patch.
4. Clinical particulars
4.1 Therapeutic indications
NiQuitin Clear relieves and/or prevents craving and nicotine
withdrawal symptoms associated with
tobacco dependence. It is 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 Clear is indicated in pregnant and lactating women making a
quit attempt.
If possible, when stopping smoking, NiQuitin Clear should be used in
conjunction with a behavioural
support programme.
4.2 Posology and method of administration
NiQuitin Clear patches should be applied once a day, at the same time
each day and preferably soon after
waking, to a non-hairy, clean, dry skin site and worn continuously for
24 hours. The NiQuitin Clear patch
should be applied promptly on removal from its protective sachet.
Avoid applying to any skin which is broken, red or irritated. After 24
hours the used patch should be
removed and a new patch applied to a fresh skin site. The patch should
not be left on for longer than 24
hours. Skin sites should not be reused for at least seven days. Only
one patch should be worn at a time.
Patches may be removed before going to bed if desired. However use for
24 hours is recommended to
optimise the effect against morning cravings.
Concurrent behavioural support is recommended, as such programmes have
been shown to be beneficial
for smoking cessation.
ADULTS (18 YEARS AND OVER)
_ABRUPT CESSAT