CHAMPIX 0.5MG FILM-COATED TABLETS

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

VARENICLINE TARTRATE

Verfügbar ab:

PFIZER (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

VARENICLINE TARTRATE

Einheiten im Paket:

11 Tablets

Hergestellt von:

Pfizer Italia S.r.l.

Gebrauchsinformation

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CHAMPIX
_®_
FILM COATED TABLET
Varenicline (0.5 mg, 1.0 mg)
PLD Title
: Varenicline (CHAMPIX
®
)
PLD Date
: 17 September 2021
Country
: Malaysia
Reference Document
: Champix Malaysia CLD dated 25 January 2021.
Reason for change
: PfLEET Number 2021-0067258 (O) – To update PLD as per effective
Malaysia CLD
dated 25 January 2021.
: To amend serial number
: To update as per BOH request.
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CHAMPIX
_®_
FILM COATED TABLET
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
11.
Serial Number.
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
be

Fachinformation

CLD Title:
Varenicline tartrate (Champix)
CLD Date:
25 January 2021
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:
PfLEET 2021-0067258 (O)- To update manufacturer details and to add
packager
address
Pfizer confidential
1
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
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 section
5.1 PHARMACODYNAMIC
PROPERTIES -_ Flexibility in Setting a Quit Date_).
Patients who cannot tolerate adverse reactions of varenicline may have
the dose lowered temporarily or
permanently to 0.5 mg twice daily.
Varenicline tablets should be swallowed whole with water. Varenicline
can be tak