CHAMPIX 1.0MG 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:

56 Tablets; 28 Tablets; 14 Tablets; 112 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 co n fid en tial
Page 1 of 28
LPD T it le: CHAM PIX (varenicline t art rat e)
LPD Dat e: 27 Sep t ember 2018
Count ry : M alay sia
Reference Document
: CDS Version 21.0 Dat ed 2 6 July 2018 (main reference) & UK SPC Dat ed
August 2018 (sect ion 4.2, 4.3, 4.4, loss of consciousness (4.7 & 4.8)5.1 & 6 ).
Reason for change: Up dat ed based on BoH recommendat ion on PRAC recommendat ion on signals
p ublished on 9 th July 2018, t he risk of loss of consciousness in Champ ix. Sect ions 4.2 (Posology and met hod of administ rat ion), 5.1 (Pharmacody namic
p rop erties), and 5.2 (Pharmacokinet ic p rop erties) of t he varenicline CDS are
being revised based on p ediat ric st udy
1. NAME OF THE MEDICINAL PRODUCT
CHAM PIX ® 0.5 mg film-coat ed t ablet s.
CHAM PIX ® 1 mg film-coat ed t ablet s.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coat ed t ablet cont ains 0.5 mg of varenicline (as t art rat e).
Each film-coat ed t ablet cont ains 1 mg of varenicline (as t art rat e).
Excip ient s:
For a full list of excip ient s, see sect ion 6.1 Li st of exci pi ents.
3. PHARMACEUTICAL FORM
Film-coat ed t ablet .
0.5 mg film-coat ed t ablet s: Whit e, film-coat ed, cap sular-shap ed, biconvex t ablet s debossed wit h “ Pfizer”
on one side and “CHX 0.5” on t he ot her side.
1 mg film-coat ed t ablet s: Light blue, film-coat ed, cap sular-shap ed, biconvex t abl et s debossed wit h “ Pfizer”
on one side and “CHX 1.0” on t he ot her side.
4. CLINICAL PARTICULARS
4.1 Therapeuti c i ndi cati ons
Varenicline is indicat ed for smoking cessat ion.
4.2 Posol ogy and method of admi ni strati on Posol ogy
T he recommended dose is 1 mg varenicline t wice daily following a 1-week t it rat ion as follows:
Day s 1 – 3: 0.5 mg once daily
Day s 4 – 7: 0.5 mg t wice daily
Day 8 – End of t reat ment : 1 mg t wice daily