Champix tablets film-coated

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

varenicline (varenicline tartrate)

Boleh didapati daripada:

R-Pharm Germany GmbH

Kod ATC:

N07BA03

INN (Nama Antarabangsa):

varenicline (varenicline tartrate)

Dos:

1mg

Borang farmaseutikal:

tablets film-coated

Unit dalam pakej:

(28/2x14/) in blister

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2018-09-12

Ciri produk

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Champix
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One tablet contains:_ _
_active ingredient_: varenicline tartrate 0.85 mg and 1.71 mg
(equivalent to 0.5 mg or 1 mg
varenicline);
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White or off-white
,
capsule-shaped, biconvex, film-coated tablets debossed with
“
Pfizer
”
on
one side and
“
CHX 0.5
”
on the other side (for 0.5 mg strength).
Light blue capsule-shaped, biconvex, film-coated tablets debossed with
“
Pfizer
”
on one side
and
“
CHX 1.0
”
on the other side (for 1.0 mg strength).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of nicotine dependency in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Method of administration _
Champix
®
is intended for oral use.
Champix
®
is taken with or without food.
Tablets should be swallowed whole with water.
_Dosage regimen _
The recommended dose of Champix
®
is 1 mg twice daily after one week of dose titration
performed in the following way:
Days 1 to 3
0.5 mg once daily
Days 4 to 7
0.5 mg twice daily
Day 8 and until the end of treatment
1 mg twice daily
A patient should set a date to stop smoking.
The administration of Champix
®
should usually
start 1 to 2 weeks before this date. Treatment with Champix
®
should be performed for 12
weeks.
Page 2 of 10
In patients who successfully stopped smoking at the end of a 12-week
period, an additional
course of 12-week treatment with Champix
®
at a dose of 1 mg twice daily should be
considered to maintain abstinence from smoking.
A gradual approach to quitting smoking with Champix
®
should be considered for patients
who are not able or willing to quit abruptly. Patients should reduce
smoking during the first 12
weeks of treatment and quit by the end of this period of treatment.
Following this patients
should continue to take Champix
®
for another 12 weeks, i.e., the total duration of treatment
will be 24 weeks.
For patients wh