CHAMPIX 0.5MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VARENICLINE TARTRATE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

VARENICLINE TARTRATE

Unit dalam pakej:

11 Tablets

Dikeluarkan oleh:

R-Pharm Germany GmbH

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CHAMPIX
_®_
_ _
Varenicline
(0.5 mg, 1.0 mg)
PLD TITLE
:
CHAMPIX
PLD DATE
:
29 July 2019
COUNTRY
:
Malaysia
REFERENCE DOCUMENT
:
Champix Malaysia LPD dated 27 Sep 2018.
REASON FOR CHANGE :
Updated based on BoH recommendation
on PRAC recommendation on signals published
on 9
th
July 2018, the risk of loss of consciousness in Champix
:
To update the PIL as per BOH comments
Pfizer Confidential
CHAMPIX
_®_
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Varenicline
(0.5 mg, 1.0 mg)
1
WHAT IS IN THIS LEAFLET
1.
What CHAMPIX is used for
2.
How CHAMPIX works
3.
Before you use CHAMPIX
4.
How to use CHAMPIX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CHAMPIX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CHAMPIX IS USED FOR
Varenicline is indicated for smoking
cessation.
HOW CHAMPIX WORKS
CHAMPIX can help to relieve the
craving and withdrawal symptoms
associated with stopping smoking.
Although you are not recommended to
smoke after your quit date, CHAMPIX
can also reduce the enjoyment of
cigarettes if you do smoke when on
treatment. (The quit date is the day in
the second week of treatment when you
will stop smoking, see section, How to
use CHAMPIX.)
BEFORE YOU USE CHAMPIX
-
_When you must not use it _
If you are allergic (hypersensitive) to
varenicline tartrate or any of the other
ingredients of CHAMPIX.
_PREGNANCY AND LACTATION _
It is preferable to avoid the use of
CHAMPIX while you are pregnant.
Talk to your doctor if you are
intending to become pregnant. If you
want to start treatment with
CHAMPIX, your treatment should be
timed so that you have completed the
course before becoming pregnant.
Animal studies suggest that
CHAMPIX may pass into breast
milk. You should ask your doctor or
pharmacist for advice before taking
CHAMPIX.
-
_Before you start to use it _
There have been reports of
depression, suicidal ideation and
behaviour and suicide attempts in
patients takin

Ciri produk

Pfizer confidential
Page 1 of 28
LPD Title:
CHAMPIX (varenicline tartrate)
LPD Date:
27 September 2018
Country:
Malaysia
Reference Document:
CDS Version 21.0 Dated 26 July 2018 (main reference) & UK SPC Dated
August 2018 (section 4.2, 4.3, 4.4, loss of consciousness (4.7 &
4.8)5.1 & 6).
Reason for change:
Updated based on BoH recommendation
on PRAC recommendation on signals
published on 9
th
July 2018, the risk of loss of consciousness in Champix.
Sections 4.2 (Posology and method of administration), 5.1
(Pharmacodynamic
properties), and 5.2 (Pharmacokinetic properties) of the varenicline
CDS are
being revised based on pediatric study
1. NAME OF THE MEDICINAL PRODUCT
CHAMPIX
®
0.5 mg film-coated tablets.
CHAMPIX
®
1 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Each film-coated tablet contains 1 mg of varenicline (as tartrate).
Excipients:
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Film-coated tablet.
0.5 mg film-coated tablets: White, film-coated, capsular-shaped,
biconvex tablets debossed with “_Pfizer_”
on one side and “CHX 0.5” on the other side.
1 mg film-coated tablets: Light blue, film-coated, capsular-shaped,
biconvex tablets debossed with “_Pfizer_”
on one side and “CHX 1.0” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Varenicline is indicated for smoking cessation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose is 1 mg varenicline twice daily following a
1-week titration as follows:
Days 1 – 3:
0.5 mg once daily
Days 4 – 7:
0.5 mg twice daily
Day 8 – End of treatment:
1 mg twice daily
Pfizer confidential
Page 2 of 28
The patient should set a date to stop smoking. Varenicline dosing
should usually start 1-2 weeks before
this date.
Alternatively, a flexible approach to quitting may be adopted: the
patient can begin varenicline dosing
and then quit smoking between days 8 and 35 of treatment (see