NICOTINELL GUM 4 MG (MINT)

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

NICOTINE

Dostopno od:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

Koda artikla:

N07BA01

Farmacevtska oblika:

CHEWING GUM

Sestava:

NICOTINE 4 MG

Pot uporabe:

PER OS

Tip zastaranja:

Not required

Izdeluje:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

Terapevtska skupina:

NICOTINE

Terapevtsko območje:

NICOTINE

Terapevtske indikacije:

As an aid to smoking cessation and for the relief of nicotine withdrawal symptoms. In smokers currently unable or not ready to stop smoking abruptly the gum may also be used as part of a program to reduce smoking prior to stopping completely.

Datum dovoljenje:

2014-08-31

Navodilo za uporabo

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
05.2013
)
:ךיראת
08.2016
:תילגנאב םירישכת םש
NICOTINELL GUM 2 MG (FRUIT); NICOTINELL GUM 2 MG (MINT);
NICOTINELL GUM 4 MG (FRUIT); NICOTINELL GUM 4 MG (MINT)
:םושירה ירפסמ
NICOTINELL GUM 2 MG (FRUIT): 115-78-29638-21; 115-78-29638-22
NICOTINELL GUM 2 MG (MINT): 115-78-29638-23; 115-78-29638-24
NICOTINELL GUM 4 MG (FRUIT): 115-79-29639-21; 115-79-29639-22
NICOTINELL GUM 4 MG (MINT): 115-79-29639-23; 115-79-29639-24 :םושירה לעב םש
)לארשי( ןיילקתימסוסקלג
מ"עב
! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
הפורתב שומישה ינפל
הפורתב שומישל תועגונה תודחוימ תורהזא אפורל רפס קיטסמ ליטוקינב שומישה ינפל
םא
:
יוקילמ רבעב תלבס וא לבוס ךניה םא
:דוקפתב
תקועת( םד ילכ וא/ו בלה
תלבס םא ,הזח
ץחל רתי ,בל בצקב תורידס יא ,בל ףקתהמ
ילכ תולחמ ,םייפגב םד תמירזב תויעב,םד
תטולב ,ןתשה תכרעמ/הילכה ,דבכה ) ,םד
תטולבב לודיג ,)דיאורית ( סירתה
תרתוי
תויעבמ ,תרכסמ ,)המוטיצמורכואפ( הילכה
,הפה ללחב תקלד ,טשווה תקלדמ ,םיינישב
( לוכיעה תכרעמ
תוערפה ,)סוקלוא ןוגכ
.תילאנומרוה תכרעמב
וללכש תויגרלא תובוגתמ רבעב תלבס םא
ןורגו םינפ ,םייתפשה לש תוחפנתה
(
angioedema
תצצקעמ רוע תחירפמ וא )
(
urticaria
)
ןשעמ ךנה ם
–
ינפל אפורל ךכ לע חוודל שי
.וז הפורתב לופיטה תלחתה
הפורתל וא והשלכ ןוזמל שיגר ךניה םא
כ
תליטנ ינפל אפורל ךכ לע עידוהל ךילע
,יהשל
.הפורתה
שי וז הפורתב לופיטה

Lastnosti izdelka

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1.
NAME OF THE MEDICINAL PRODUCT
Nicotinell Gum 2 mg (Fruit); Nicotinell Gum 2 mg (Mint);
Nicotinell Gum 4 mg (Fruit); Nicotinell Gum 4 mg (Mint)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotinell Gum 2 mg (Fruit) / Nicotinell Gum 2 mg (Mint):
One piece of medicated chewing gum contains 2 mg nicotine .
Nicotinell Gum 4 mg (Fruit) / Nicotinell Gum 4 mg (Mint):
One piece of medicated chewing gum contains 4 mg nicotine .
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewing gum
Each piece of coated chewing gum is offwhite in colour and rectangular
in shape
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an aid to smoking cessation and for the relief of nicotine
withdrawal symptoms.
In smokers currently unable or not ready to stop smoking abruptly the
gum may also be used as
part of a program to reduce smoking prior to stopping completely
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ELDERLY
2 mg strength:
One piece of Nicotinell gum to be chewed when the user feels the urge
to smoke. Normally, 8-12
pieces per day can be used, up to a maximum of 25 pieces per day.
The 2 mg chewing gum is recommended in smokers with a low to moderate
nicotine dependency.
The 2 mg chewing gum may not be well suited to smokers with a strong
or very strong nicotine
dependency.
4 mg strength:
One piece of Nicotinell gum to be chewed when the user feels the urge
to smoke. Normally, 8-12
pieces per day can be used, up to a maximum of 15 pieces per day.
The 4 mg chewing gum is intended to be used by smokers with a strong
or very strong nicotine
dependency and those who have previously failed to stop smoking with
the aid of nicotine
replacement therapy.
The optimal dosage form is selected according to the following table:
If an adverse event is noted when high dose forms are initiated, this
should be replaced by the lower
dosage form.
The characteristics of chewing-gum as a pharmaceutical form are such
that individually different
nicotine levels can result in the blood. Therefore, dosage frequency
sho