Champix Tablet 1mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Varenicline Tartrate 1.71 mg eqv. Varenicline

Available from:

PFIZER PRIVATE LIMITED

ATC code:

N07BA03

Dosage:

1 mg/tablet

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Varenicline Tartrate 1.71 mg eqv. Varenicline 1 mg/tablet

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Italia S.r.l.

Authorization status:

ACTIVE

Authorization date:

2007-08-01

Patient Information leaflet

MEDICATION GUIDE
CHAMPIX
®
(Varenicline) Tablets
Read the Medication Guide that comes with CHAMPIX before you start
taking it and
each time you get a refill. There may be new information. This
information does not take
the place of talking with your doctor about your condition or
treatment.
What is the most important information I should know about CHAMPIX?
Some people have had serious side effects while using CHAMPIX to help
them quit
smoking including: New or worse mental health problems, such as
changes in behavior,
hostility, agitation, depressed mood, and suicidal thoughts or
actions. Some people had
these symptoms when they began taking CHAMPIX, and others developed
them after
several weeks of treatment, or after stopping CHAMPIX.
Before taking CHAMPIX, tell your doctor if you have ever had
depression or other
mental health problems. You should also tell your doctor about any
symptoms you had
during other times you tried to quit smoking, with or without CHAMPIX.
Stop taking CHAMPIX and call your doctor right away if you, your
family, or caregiver
notice agitation, hostility, depression or changes in your behavior or
thinking that are not
typical for you, or you develop any of the following symptoms:

thoughts about suicide or dying, or attempts to commit suicide

new or worse depression, anxiety, or panic attacks

feeling very agitated or restless

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

abnormal thoughts or sensations

seeing or hearing things that are not there (hallucinations)

feeling people are against you (paranoia)

feeling confused

other unusual changes in behavior or mood
When you try to quit smoking, with or without CHAMPIX, you may have
symptoms that
may be due to nicotine withdrawal, including urge to smoke, depressed
mood, trouble
sleeping, irritability, frustration, anger, feeling anxious,
difficulty concentrating,
restlessness, decreased heart rate, and increased appetite

Summary of Product characteristics

CHAMPIX™
(VARENICLINE) TABLETS
1
NAME OF THE MEDICINAL PRODUCT
CHAMPIX
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).
3
PHARMACEUTICAL FORM
Film-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHAMPIX is indicated as an aid to smoking cessation treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
USUAL DOSAGE FOR ADULTS
Smoking cessation therapies are more likely to succeed for patients
who are motivated to stop
smoking and who are provided additional advice and support. Patients
should be provided with
appropriate educational materials and counseling to support the quit
attempt.
The patient should set a date to stop smoking. CHAMPIX dosing should
start one week before
this date. Alternatively, the patient can begin CHAMPIX dosing and
then quit smoking between
days 8 and 35 of treatment (see section 5.1 PHARMACODYNAMIC PROPERTIES
- _Flexibility in _
_Setting a Quit Date_).
The recommended dose of CHAMPIX is 1 mg 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
Patients should be treated with CHAMPIX for 12 weeks. For patients who
have successfully
stopped smoking at the end of 12 weeks, an additional course of 12
weeks treatment with
CHAMPIX at 1 mg twice daily is recommended for the maintenance of
abstinence (see section
5.1 PHARMACODYNAMIC PROPERTIES - _Maintenance of Abstinence Study_).
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 that treatment period. Patients
should then continue taking
CHAMPIX for an additional 12 weeks for a total of 24 weeks of
treatment (see section 5.1
PHARMACODYNAMIC PROPERTIES – _Gradual approach to quitting
smoking_).
Patients who do not suc