NICOTINELL 21 mg 24h patch

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

NICOTINE

Disponible des:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

Codi ATC:

N07BA01

formulario farmacéutico:

PATCHES

Composición:

NICOTINE 52.5 MG

Vía de administración:

TRANSDERMAL

tipo de receta:

Not required

Fabricat per:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

Grupo terapéutico:

NICOTINE

Área terapéutica:

NICOTINE

indicaciones terapéuticas:

Aid to smoking cessation.

Data d'autorització:

2012-05-31

Fitxa tècnica

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_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in Februdary 2017 _
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1.
NAME OF THE MEDICINAL PRODUCT
NICOTINELL
7mg/24h patch
NICOTINELL
14mg/24h patch
NICOTINELL
21mg/24h patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nicotinell 7MG/24H PATCH patch contains 17.5 mg S(-)-nicotine
which provides an average
absorption rate of 7 mg nicotine in 24 hours.
Each Nicotinell 14MG/24H PATCH patch contains 35.0 mg S(-)-nicotine
which provides an average
absorption rate of 14 mg nicotine in 24 hours.
Each Nicotinell 21MG/24H PATCH patch contains 52.5 mg S(-)-nicotine
which provides an average
absorption rate of 21 mg nicotine in 24 hours.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patches
The Nicotinell patch is a transdermal therapeutic system, consisting
of a round, flat, matrix-type self-
adhesive, yellowish-ochre coloured patch. It is protected by a
rectangular metallic release liner
backing to be discarded before application.
Nicotinell 7MG/24H PATCH patch 7mg/24 hour has a drug releasing area
of 10 cm
2
and is printed
CG CWC on the patch surface.
Nicotinell 14MG/24H PATCH patch 14mg/24 hour has a drug releasing area
of 20 cm
2
and is printed
CG FEF on the patch surface.
Nicotinell 21MG/24H PATCH patch 21mg/24 Hour has a drug releasing area
of 30 cm
2
and is printed
CG EME on the patch surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aid to smoking cessation
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
For individuals smoking 20 cigarettes or more a day, it is recommended
that treatment be started with
Nicotinell 21MG/24H PATCH (Step 1) once daily, applied to a dry
non-hairy area of the skin on the
trunk or upper arm. Those smoking less than this are recommended to
start with Nicotinell 14MG/24H
PATCH (Step 2). Sizes of 30cm
2
, 20cm
2
and 10cm
2
are available to permit gradual withdrawal of
nicotine replacement, using treatment periods of 3-4 weeks (for each
size). The siz