Champix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

varenicline

Available from:

Pfizer Europe MA EEIG

ATC code:

N07BA03

INN (International Name):

varenicline

Therapeutic group:

Other nervous system drugs

Therapeutic area:

Tobacco Use Cessation

Therapeutic indications:

Champix is indicated for smoking cessation in adults.

Product summary:

Revision: 38

Authorization status:

Authorised

Authorization date:

2006-09-25

Patient Information leaflet

117
B. PACKAGE LEAFLET
118
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHAMPIX 0.5 MG FILM-COATED TABLETS
CHAMPIX 1 MG FILM-COATED TABLETS
varenicline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CHAMPIX is and what it is used for
2.
What you need to know before you take CHAMPIX
3.
How to take CHAMPIX
4.
Possible side effects
5.
How to store CHAMPIX
6.
Contents of the pack and other information
1.
WHAT CHAMPIX IS AND WHAT IT IS USED FOR
CHAMPIX contains the active substance varenicline. CHAMPIX is a
medicine which is used in adults
to help them stop smoking.
CHAMPIX can help to relieve the craving and withdrawal symptoms
associated with stopping
smoking.
CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke
when on treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHAMPIX
DO NOT TAKE CHAMPIX
-
If you are allergic to varenicline or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking CHAMPIX.
There have been reports of depression, suicidal ideation and behaviour
and suicide attempts in patients
taking CHAMPIX. If you are taking CHAMPIX and develop agitation,
depressed mood, changes in
behaviour that are of concern to you or your family or if you develop
suicidal thoughts or behaviours
you should stop taking CHAMPIX and contact your doctor immediately for
treatment assessment.
119
_The effects of stopping smoking _
The effects of changes in your body resulting from stopping smoking,
with or wit

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each film-coated tablet contains 0.5 mg of varenicline (as tartrate).
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet of 4 mm x 8 mm
White, capsular-shaped, biconvex tablets debossed with “
_Pfizer_
” on one side and “CHX 0.5” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHAMPIX is indicated for smoking cessation in adults.
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. CHAMPIX dosing should
usually start at 1-2 weeks
before this date (see section 5.1). 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 may be considered
for the maintenance of
abstinence (see section 5.1).
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).
Patients who are motivated to quit and who did not succeed in stopping
smoking during prior
CHAMPIX therapy, or who relapsed after treatment, may benefit from
another quit attempt with
CHAMPIX (see section 5.1).
Patients who cannot tolerate adverse reactions of CHAMPIX may have the
dose lowered temporarily
or permanently to 0.5 mg twice daily.
3
In smoking cessation therapy, risk for relapse to smoking is elevated
in the period immedi