NICOTINELL LOZENGES 2 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

NICOTINE

Tilgængelig fra:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC-kode:

N07BA01

Lægemiddelform:

LOZENGES

Sammensætning:

NICOTINE 2 MG

Indgivelsesvej:

PER OS

Recept type:

Not required

Fremstillet af:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

Terapeutisk gruppe:

NICOTINE

Terapeutisk område:

NICOTINE

Terapeutiske indikationer:

An aid to smoking cessation, relief of symptoms associated with nicotine withdrawal.In smokers currently unable or not ready to stop smoking abruptly the lozenges may also be used as part of a program to reduce smoking prior to stopping completely.

Autorisation dato:

2013-12-31

Produktets egenskaber

_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in _
_June 2017 _
1.
NAME OF THE MEDICINAL PRODUCT
Nicotinell Lozenges 1 mg
Nicotinell Lozenges 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of Nicotinell Lozenges 1 mg contains:
Active substance: 1 mg nicotine (corresponding to 3.072 mg nicotine
bitartrate dihydrate).
Each piece of Nicotinell Lozenges 2 mg contains:
Active substance: 2 mg nicotine (corresponding to 6.144 mg nicotine
bitartrate dihydrate).
Excipient(s): aspartame (0.01 g), maltitol (0.9 g) and sodium (9.8
mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenges
White, mint flavoured, round biconvex lozenge
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicotinell Lozenges are indicated in adults.
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
CHILDREN AND ADOLESCENTS (< 18 YEARS)
Nicotinell lozenges should not be used by people under 18 years of
age. There is no experience in
treating adolescents under the age of 18 with Nicotinell lozenges.
ADULTS AND ELDERLY
POSOLOGY:
Nicotinell Lozenges 1 mg is recommended in smokers with a low to
moderate nicotine dependency. It
is not recommended in the case of smokers with a strong or very strong
nicotine dependency.
Nicotinell Lozenges 2 mg 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 occurs with the use of the high dose form (2 mg
lozenge), use of the low dose form
(1 mg lozenge) should be considered.
The initial dosage should be individualised on the basis of the
patients nicotine dependence.